WorldWideScience

Sample records for research involving humans

  1. Ethical issues in neonatal research involving human subjects.

    Science.gov (United States)

    Fleischman, Alan R

    2016-06-01

    Research involving critically ill neonates creates many ethical challenges. Neonatal clinical research has always been hard to perform, is very expensive, and may generate some unique ethical concerns. This article describes some examples of historical and modern controversies in neonatal research, discusses the justification for research involving such vulnerable and fragile patients, clarifies current federal regulations that govern research involving neonates, and suggests ways that clinical investigators can develop and implement ethically grounded human subjects research. Copyright © 2016 Elsevier Inc. All rights reserved.

  2. Regulating hematology/oncology research involving human participants.

    Science.gov (United States)

    Kapp, Marshall B

    2002-12-01

    The conduct of hematology/oncology research, particularly clinical trials involving human participants, is an extensively regulated enterprise. Professionals in the specialty of hematology/oncology have important stakes in the success of biomedical research endeavors. Knowledge about and compliance strategies regarding the pertinent regulatory parameters are essential for avoiding negative legal repercussions for involved professionals. At the same time, there is a need to be aware of and actively resist the danger that strong [legal] protectionism might inadvertently result in undermining physician investigators' sense of personal moral responsibility in the conduct of human experiments. For all the limitations of that virtue in the protection of human subjects, it is surely not one that we would want medical scientists to be without [47]. Members of the potential participant pool, financial sponsors, and the general public must be convinced that everyone involved in the research enterprise is committed to operating within acceptable legal and ethical boundaries if the atmosphere of confidence and trust that is indispensable to the continued process and progress of investigation aimed at extending and improving quality of life for all of us in the future is to continue and flourish [48].

  3. Committees for Ethics in Research involving human subjects.

    Science.gov (United States)

    Hossne, William Saad; Vieira, Sonia; De Freitas, Corina Bontempo Duca

    2008-01-01

    In Brazil since October 1996 there have been guidelines for research involving human subjects. Now human subjects know when their treatment is part of research. Deceit is no longer tolerated. But is not enough to say we offer an explanation to the potential subject and we offer a choice before he or she is confronted with an informed consent form. As in all professional activity, scientific investigation needs social controls. In Brazil, the ultimate responsibility of an investigation lies on the investigator, but in every institution where research is carried out there is a Committee for Ethics in Research. All Committees are subordinated to the National Commission of Ethics in Research, which is submitted to the Brazilian Institute of Health. During 2005 around 17,000 protocols involving 700,000 human subjects were revised by 475 Committees distributed all over the country. Approximately 7,000 people are now working in these Committees.

  4. Trends in research involving human beings in Brazil

    Directory of Open Access Journals (Sweden)

    Ricardo Eccard da Silva

    2015-02-01

    Full Text Available Developing countries have experienced a dramatic increase in the number of clinical studies in the last decades. The aim of this study was to describe 1 the number of clinical trials submitted to the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, Anvisa from 2007 to 2012 and the number of human-subject research projects approved by research ethics committees (RECs and the National Research Ethics Committee (Comissão Nacional de Ética em Pesquisa, CONEP in Brazil from 2007 to 2011 and 2 the diseases most frequently studied in Brazilian states in clinical trials approved in the country from 2009 to 2012, based on information from an Anvisa databank. Two databases were used: 1 the National Information System on Research Ethics Involving Human Beings (Sistema Nacional de Informação Sobre Ética em Pesquisa envolvendo Seres Humanos, SISNEP and 2 Anvisa's Clinical Research Control System (Sistema de Controle de Pesquisa Clínica, SCPC. Data from the SCPC indicated an increase of 32.7% in the number of clinical trials submitted to Anvisa, and data from the SISNEP showed an increase of 69.9% in those approved by RECs and CONEP (from 18 160 in 2007 to 30 860 in 2011. Type 2 diabetes (26.0% and breast cancer (20.5%-related to the main causes of mortality in Brazil-were the two most frequently studied diseases. The so-called “neglected diseases,” such as dengue fever, were among the least studied diseases in approved clinical trials, despite their significant impact on social, economic, and health indicators in Brazil. Overall, the data indicated 1 a clear trend toward more research involving human beings in Brazil, 2 good correspondence between diseases most studied in clinical trials approved by Anvisa and the main causes of death in Brazil, and 3 a low level of attention to neglected diseases, an issue that should be considered in setting future research priorities, given their socioeconomic and health effects.

  5. Involving Nepali academics in health research

    DEFF Research Database (Denmark)

    Neupane, Dinesh; van Teijlingen, E; Khanal, V

    2013-01-01

    Many academics from Nepal do not involve in research activities. There are several factors hindering the involvement such as inadequate human resources and lack of financial resources. Despite limited human and financial resources, we believe it is still possible to attract many Nepali academics...... in health research. This paper purposes some ideas to increase involvement of Nepali academics in health research....

  6. 75 FR 62738 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides...

    Science.gov (United States)

    2010-10-13

    ... addressed in EPA science and ethics reviews of proposed and completed human research for pesticides, based... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides; Notification to... protection of human subjects of research that apply to third parties who conduct or support research for...

  7. 76 FR 5735 - Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides

    Science.gov (United States)

    2011-02-02

    ... addressed in EPA science and ethics reviews of proposed and completed human research with pesticides, drawn..., which suggest ethical considerations relevant to evaluation of human studies. Third, Petitioners argued... Revisions to EPA's Rule on Protections for Subjects in Human Research Involving Pesticides AGENCY...

  8. Reporting of ethical protection in recent oral and maxillofacial surgery research involving human subjects.

    Science.gov (United States)

    Pitak-Arnnop, P; Sader, R; Hervé, C; Dhanuthai, K; Bertrand, J-Ch; Hemprich, A

    2009-07-01

    This retrospective observational study investigated the frequency of reporting ethical approval and informed consent in recently published oral and maxillofacial surgery (OMS) research involving human subjects. All research involving human subjects published in the International Journal of Oral and Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, and Journal of Cranio-Maxillofacial Surgery during January to June 2005-2007 were analysed for disclosure of ethical approval by a local ethical committee and obtaining informed consent from the subjects. 534 articles were identified; ethical approval was documented in 118 (22%) and individual patient consent in 135 (25%). 355 reports (67%) did not include a statement on ethical approval or informed consent and only 74 reports (14%) disclosed statements of both. Ethical documentation in retrospective and observational studies was scant; 12% of randomised controlled trials and 38% of non-random trials did not report both of ethical protections. Most recent OMS publications involving humans failed to mention ethical review or subjects' consent. Authors must adhere to the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity and maintain public trust in the experimental process and OMS profession.

  9. Conflicts of interest in research involving human beings.

    Science.gov (United States)

    Greco, Dirceu; Diniz, Nilza Maria

    2008-01-01

    Conflicts of interest are inherent to the majority of relationships among individuals and of these with companies and institutions and, certainly, research involving human beings is no exception. In relation to clinical research, the main focus of this manuscript, conflicts of interest occur at different levels and usually permeate among them: In the pharmaceutical industry in their decisions to invest to develop new products, especially vaccines and drugs, and also in relation to marketing of these products; Among the investigators the conflicts may be related to the financial gains to participate in pharma sponsored trials, or to the expected academic career boost attained with the publication of the results of the trials and also to personal interests such as the financial support for trips to international conferences. Often the participation of host country investigators is restricted to performing phase III or IV protocols developed abroad, many times with low scientific relevance, and even lower relevance to public health; Universities or research institutes themselves also have conflicts of interest, as the sponsored projects may help increase their budgets, both directly (taxes) and indirectly (e.g., improvement of physical infrastructure of laboratories or out patient clinics); For the trial volunteers in developing countries, and Brazil is no exception despite free and universal access to its health system, participation in clinical trials is many times seen as, and can really be, an unique opportunity of receiving better health care, better treatment by the health professionals, easier access to costly lab exams and also to receiving certain medications which would otherwise be difficult to have access to. In order to handle these conflicts of interest, Brazil has a well-established and respected legal support and ethical normatization. The latter is represented by Resolution 196/96 of the Brazilian National Research Ethics Committee (CONEP). This

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

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-30

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

  11. TOXICOLOGICAL RESEARCH INVOLVING HUMANS: ETHICAL AND REGULATORY CONSIDERATIONS

    Science.gov (United States)

    This paper discusses the need for the Society of Toxicology (SOT) to develop a policy for ethical research in humans, and a review for publication of these studies. Observations on human beings have been the foundation upon which toxicologic knowledge has been built since the in...

  12. The Human Rights Context for Ethical Requirements for Involving People with Intellectual Disability in Medical Research

    Science.gov (United States)

    Iacono, T.; Carling-Jenkins, R.

    2012-01-01

    Background: The history of ethical guidelines addresses protection of human rights in the face of violations. Examples of such violations in research involving people with intellectual disabilities (ID) abound. We explore this history in an effort to understand the apparently stringent criteria for the inclusion of people with ID in research, and…

  13. Canadian governance of health research involving human subjects: is anybody minding the store?

    Science.gov (United States)

    McDonald, M

    2001-01-01

    From an ethical perspective, good governance involves the translation of collective moral intentions into effective and accountable institutional actions. With respect to the use of human subjects in Canadian health research, I contend that there have been many good intentions but very little in the way of appropriate governance arrangements. Hence, the question, "who minds the store?" is especially acute with respect to the protection of vulnerable individuals and groups that are typically recruited as subjects for health research in Canada. Beyond diagnosing failures in governance and their causes, I offer suggestions for significant reforms, including evidence-based ethics assessment, independent oversight, and greater participation of research subjects in governance. I will close with some more general reflections on ethics, law, and governance.

  14. The Public Health Service guidelines. Governing research involving human subjects: An analysis of the policy-making process

    Science.gov (United States)

    Frankel, M. S.

    1972-01-01

    The policy making process which led to development of the Public Health Service Guidelines governing research involving human subjects is outlined. Part 1 examines the evolution of PHS Guidelines, tracing (1) evolution of thought and legal interpretation regarding research using human subjects; (2) initial involvement of the Federal government; (3) development of the government's research program; (4) the social-political environment in which formal government policy was developed; and (5) various policy statements issued by the government. Part 2 analyzes the process by which PHS Guidelines were developed and examines the values and other underlying factors which contributed to their development. It was concluded that the evolution of the Guidelines is best understood within the context of a mixed-scanning strategy. In such a strategy, policy makers make fundamental decisions regarding the basic direction of policy and subsequent decisions are made incrementally and within the contexts set by the original fundamental decisions.

  15. Basic Science Research and the Protection of Human Research Participants

    Science.gov (United States)

    Eiseman, Elisa

    2001-03-01

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

  16. Mapping Frontier Research in the Humanities

    DEFF Research Database (Denmark)

    Knowledge production in academia today is burgeoning and increasingly interdisciplinary in nature. Research within the humanities is no exception: it is distributed across a variety of methodic styles of research and increasingly involves interactions with fields outside the narrow confines of th...... and for the organisation of the humanities and higher education?...... of the university. As a result, the notion of liberal arts and humanities within Western universities is undergoing profound transformations. In Mapping Frontier Research in the Humanities, the contributors explore this transformative process. What are the implications, both for the modes of research......Knowledge production in academia today is burgeoning and increasingly interdisciplinary in nature. Research within the humanities is no exception: it is distributed across a variety of methodic styles of research and increasingly involves interactions with fields outside the narrow confines...

  17. 48 CFR 207.172 - Human research.

    Science.gov (United States)

    2010-10-01

    ... 48 Federal Acquisition Regulations System 3 2010-10-01 2010-10-01 false Human research. 207.172... OF DEFENSE ACQUISITION PLANNING ACQUISITION PLANNING Acquisition Plans 207.172 Human research. Any DoD component sponsoring research involving human subjects— (a) Is responsible for oversight of...

  18. Quantifying Engagement: Measuring Player Involvement in Human-Avatar Interactions

    Science.gov (United States)

    Norris, Anne E.; Weger, Harry; Bullinger, Cory; Bowers, Alyssa

    2014-01-01

    This research investigated the merits of using an established system for rating behavioral cues of involvement in human dyadic interactions (i.e., face-to-face conversation) to measure involvement in human-avatar interactions. Gameplay audio-video and self-report data from a Feasibility Trial and Free Choice study of an effective peer resistance skill building simulation game (DRAMA-RAMA™) were used to evaluate reliability and validity of the rating system when applied to human-avatar interactions. The Free Choice study used a revised game prototype that was altered to be more engaging. Both studies involved girls enrolled in a public middle school in Central Florida that served a predominately Hispanic (greater than 80%), low-income student population. Audio-video data were coded by two raters, trained in the rating system. Self-report data were generated using measures of perceived realism, predictability and flow administered immediately after game play. Hypotheses for reliability and validity were supported: Reliability values mirrored those found in the human dyadic interaction literature. Validity was supported by factor analysis, significantly higher levels of involvement in Free Choice as compared to Feasibility Trial players, and correlations between involvement dimension sub scores and self-report measures. Results have implications for the science of both skill-training intervention research and game design. PMID:24748718

  19. Reflections on the United States National Institutes of Health draft guidelines for research involving human pluripotent stem cells--theological perspective.

    Science.gov (United States)

    Sotis, J J

    2000-01-01

    Since the human embryonic stem cell research involves destruction of human embryos and, therefore, hinges on the fundamental question of the status of the embryo, it is essential to examine this status carefully in order to establish fitting guidelines for research. The US National Institutes of Health has proposed its own guidelines on the matter recently (1999). The document, rooted in current pluralistic perspectives in moral philosophy (or bioethics), is criticised in this paper as morally inadequate. The argumentation of the criticism stems from the theological perspective on human personhood, which focuses on a continuity of personal identity from embryos to adult human beings. An additional concern for the author is the moral complicity in which the research dependent upon the destruction of human embryonic life is sanctioned.

  20. The AIR's policy on research involving the irradiation of human subjects

    International Nuclear Information System (INIS)

    Smith, A.N.

    1995-01-01

    The policy of the Australian Institute of Radiography with regards to the human subject irradiation is outlined. It is stated that members will not irradiate another individual, nor themselves, solely for the purposes of experimentation or research without gaining the prior approval of an institutional ethics committee. Where possible, researchers should consider the use of patient equivalent or human tissue equivalent phantoms. A short list of references has been compiled to assist members in designing research protocols which comply with the stated policy

  1. 40 CFR 26.1203 - Prohibition of research involving intentional exposure of any human subject who is a pregnant...

    Science.gov (United States)

    2010-07-01

    ... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of research involving intentional exposure of any human subject who is a pregnant woman (and therefore her fetus), a nursing woman, or a child. 26.1203 Section 26.1203 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY GENERAL...

  2. 40 CFR 26.203 - Prohibition of research conducted or supported by EPA involving intentional exposure of any human...

    Science.gov (United States)

    2010-07-01

    ... her fetus), a nursing woman, or child. 26.203 Section 26.203 Protection of Environment ENVIRONMENTAL... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of research conducted or... Involving Intentional Exposure of Human Subjects who are Children or Pregnant or Nursing Women § 26.203...

  3. 78 FR 10538 - Protections for Subjects in Human Research Involving Pesticides

    Science.gov (United States)

    2013-02-14

    ... involving intentional exposure of children or of pregnant or nursing women, unless relying on the data is crucial to a decision that would impose a more stringent regulatory restriction that would improve... itself to conduct or support any research involving intentional exposure of pregnant or nursing women or...

  4. Attribution of human characteristics and bullying involvement in childhood: Distinguishing between targets

    NARCIS (Netherlands)

    Noorden, T.H.J. van; Haselager, G.J.T.; Lansu, T.A.M.; Cillessen, A.H.N.; Bukowski, W.M.

    2016-01-01

    This investigation researched the association between the attribution of human characteristics and bullying involvement in children by distinguishing between targets. Study 1 focused on the attribution of human characteristics by bullies, victims, bully/victims, and non-involved children toward

  5. Policy Writing as Dialogue: Drafting an Aboriginal Chapter for Canada's Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

    Directory of Open Access Journals (Sweden)

    Jeff Reading

    2010-07-01

    Full Text Available Writing policy that applies to First Nations, Inuit and Métis peoples in Canada has become more interactive as communities and their representative organizations press for practical recognition of an Aboriginal right of self-determination. When the policy in development is aimed at supporting “respect for human dignity” as it is in the case of ethics of research involving humans, the necessity of engaging the affected population becomes central to the undertaking.

  6. Getting involved in research.

    Science.gov (United States)

    Banner, Davina; Grant, Lyle G

    2011-01-01

    The need for quality nursing research to promote evidence-based practice and optimize patient care is well recognized. This is particularly pertinent in cardiovascular nursing, where cardiovascular disease continues to be the leading cause of morbidity and mortality worldwide (World Health Organization, 2007). Across the spectrum of academic, clinical, and health care administration nursing roles, research remains fundamental to bridging theory, practice, and education (LoBiondo-Wood, Haber, Cameron, & Singh, 2009). Despite recognition of the importance of nursing research, the gap between research and practice continues to be an ongoing issue (Funk, Tornquist, & Champagne, 1995; Pettengill, Gillies, & Clark, 1994; Rizzuto, Bostrom, Suterm, & Chenitz, 1994; Rolfe, 1998). Nurses are appropriately situated to contribute to research that improves clinical outcomes and health service delivery. However, the majority of nurses in clinical practice do not have a significant research component structured into their nursing role. In this research column, the authors outline the importance of nurses being engaged in research and present some different levels of involvement that nurses may assume. A continuum of nursing research involvement includes asking researchable questions, being a savvy consumer of research evidence, finding your own level of research involvement, and aspiring to lead.

  7. Human research ethics committees in technical universities.

    Science.gov (United States)

    Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

    2014-07-01

    Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although mandated in the United States, the United Kingdom, Canada, and Australia, non-medical research involving humans need not receive ethics review in much of Europe, Asia, Latin America, and Africa. Our survey of the top 50 technical universities in the world shows that, where not specifically mandated by law, most technical universities do not employ ethics committees to review human studies. As the domains of basic and applied sciences expand, ethics committees are increasingly needed to guide and oversee all such research regardless of legal requirements. We offer as examples, from our experience as an ethics committee in a major European technical university, ways in which such a committee provides needed services and can help ensure more ethical studies involving humans outside the standard medical context. We provide some arguments for creating such committees, and in our supplemental article, we provide specific examples of cases and concerns that may confront technical, engineering, and design research, as well as outline the general framework we have used in creating our committee. © The Author(s) 2014.

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

    Science.gov (United States)

    Jansson, Roger L

    2003-02-01

    Two sets of federal regulations, the "Common Rule" and Food and Drug Administration (FDA) regulations, govern human subject research that is either federally-funded or involves FDA regulated products. These regulations require, inter alia, that: (1) researchers obtain informed consent from human subjects, and (2) that an Institutional Review Board (IRB) independently review and approve the research protocol. Although the federal regulations do not provide an express cause of action against researchers, research subjects should be able to bring informed consent and malpractice actions against researchers by establishing a duty of care and standard of care. Researchers owe human subjects a duty of care analogous to the special relationship between physicians and patients. The federal regulations should provide the minimum standard of care for informed consent in human subject research, and complying with them should be a partial defense. In contrast, expert testimony should establish the standard of care for researcher malpractice, and IRB approval should be a partial defense.

  9. Undergraduate research involving human subjects should not be granted ethical approval unless it is likely to be of publishable quality.

    Science.gov (United States)

    Gallagher, Cathal T; McDonald, Lisa J; McCormack, Niamh P

    2014-06-01

    Small-scale research projects involving human subjects have been identified as being effective in developing critical appraisal skills in undergraduate students. In deciding whether to grant ethical approval to such projects, university research ethics committees must weigh the benefits of the research against the risk of harm or discomfort to the participants. As the learning objectives associated with student research can be met without the need for human subjects, the benefit associated with training new healthcare professionals cannot, in itself, justify such risks. The outputs of research must be shared with the wider scientific community if it is to influence future practice. Our survey of 19 UK universities indicates that undergraduate dissertations associated with the disciplines of medicine, dentistry and pharmacy are not routinely retained in their library catalogues, thus closing a major avenue to the dissemination of their findings. If such research is unlikely to be published in a peer-reviewed journal, presented at a conference, or otherwise made available to other researchers, then the risks of harm, discomfort or inconvenience to participants are unlikely to be offset by societal benefits. Ethics committees should be satisfied that undergraduate research will be funnelled into further research that is likely to inform clinical practice before granting ethical approval.

  10. What's Wrong with Human/Nonhuman Chimera Research?

    Science.gov (United States)

    Hyun, Insoo

    2016-08-01

    The National Institutes of Health (NIH) is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed.

  11. Development and oversight of ethical health promotion quality assurance and evaluation activities involving human participants.

    Science.gov (United States)

    Sainsbury, Peter

    2015-12-01

    This paper considers the role of ethics and ethics review processes in the development of health promotion quality assurance and evaluation activities involving human participants. The Australian National Health and Medical Research Council (NHMRC) National Statement on Ethical Conduct in Human Research and associated documents provide the framework for the ethical conduct and independent review of research (including quality assurance and evaluation) involving humans in Australia. Identifying the level of risk to which participants may be exposed by participation in quality assurance and evaluation activities is essential for health promotion workers undertaking such activities. Organisations can establish processes other than review by a Human Research Ethics Committee for negligible and low risk research activities. Health promotion quality assurance and evaluation activities often involve negligible and low risk to participants. Seven triggers that indicate the need for ethics review of quality assurance and evaluation activities and a procedural checklist for developing ethical quality assurance and evaluation activities are provided. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research. When ethical considerations underpin the planning and conduct of all quality assurance and evaluation from the very beginning, the activity is the better for it, independent 'ethics approval' can mostly be secured without much trouble and workers' frustration levels are reduced. So what? Health promotion quality assurance and evaluation activities must be ethically justified. Health promotion workers should be familiar with the NHMRC's National Statement on Ethical Conduct in Human Research and should use it when developing health promotion quality assurance and evaluation activities.

  12. What's Wrong with Human/Nonhuman Chimera Research?

    Directory of Open Access Journals (Sweden)

    Insoo Hyun

    2016-08-01

    Full Text Available The National Institutes of Health (NIH is poised to lift its funding moratorium on research involving chimeric human/nonhuman embryos, pending further consideration by an NIH steering committee. The kinds of ethical concerns that seem to underlie this research and chimera research more generally can be adequately addressed.

  13. Status, challenges and facilitators of consumer involvement in Australian health and medical research

    Directory of Open Access Journals (Sweden)

    Girgis Afaf

    2010-11-01

    Full Text Available Abstract Background The emergent international practice of involving consumers in health research is driven, in part, by the growing share of health research that can only be applied in and emerge from knowledge that is shaped by human values and societal contexts. This is the first investigation of its kind to identify the current prevalence, challenges, enabling factors and range of approaches to consumer involvement in health and medical research in Australia. Methods A nation-wide survey of research funding organisations and organisations that conduct research was performed during 2008-2009. Results Marked variation in consumer involvement experience and perceptions exists between research funders and researchers. Research funders were over eight times more likely than organisations conducting research to involve consumers in identifying research needs and prioritising research topics. Across both groups, practical and time constraints were reported as key challenges to involving consumers, while guidelines on consumer involvement and evidence of effect were the most important potential enablers. More than a third of research organisations indicated that when consumer involvement was a condition of research funding, it was an important facilitator of involvement. Conclusion It is no longer simply enough to keep society informed of important scientific breakthroughs. If Australian health research is to take into account important social contexts and consequences, it must involve consumers. A set of minimum consumer involvement standards and associated guidelines, that are agreed and routinely adopted, could ensure that consumers and the Australian community they represent, are given an opportunity to shed light on experiences and local circumstance, and express views and concerns relevant to health research.

  14. Ethics education in research involving human beings in undergraduate medicine curriculum in Brazil.

    Science.gov (United States)

    Novaes, Maria Rita Garbi; Guilhem, Dirce; Barragan, Elena; Mennin, Stewart

    2013-12-01

    The Brazilian national curriculum guidelines for undergraduate medicine courses inspired and influenced the groundwork for knowledge acquisition, skills development and the perception of ethical values in the context of professional conduct. The evaluation of ethics education in research involving human beings in undergraduate medicine curriculum in Brazil, both in courses with active learning processes and in those with traditional lecture learning methodologies. Curricula and teaching projects of 175 Brazilian medical schools were analyzed using a retrospective historical and descriptive exploratory cohort study. Thirty one medical schools were excluded from the study because of incomplete information or a refusal to participate. Active research for information from institutional sites and documents was guided by terms based on 69 DeCS/MeSH descriptors. Curriculum information was correlated with educational models of learning such as active learning methodologies, tutorial discussions with integrated curriculum into core modules, and traditional lecture learning methodologies for large classes organized by disciplines and reviewed by occurrence frequency of ethical themes and average hourly load per semester. Ninety-five medical schools used traditional learning methodologies. The ten most frequent ethical themes were: 1--ethics in research (26); 2--ethical procedures and advanced technology (46); 3--ethic-professional conduct (413). Over 80% of schools using active learning methodologies had between 50 and 100 hours of scheduled curriculum time devoted to ethical themes whereas more than 60% of traditional learning methodology schools devoted less than 50 hours in curriculum time to ethical themes. The data indicates that medical schools that employ more active learning methodologies provide more attention and time to ethical themes than schools with traditional discipline-based methodologies. Given the importance of ethical issues in contemporary medical

  15. Involving disabled children and young people as partners in research: a systematic review.

    Science.gov (United States)

    Bailey, S; Boddy, K; Briscoe, S; Morris, C

    2015-07-01

    Children and young people can be valuable partners in research, giving their unique perspectives on what and how research should be done. However, disabled children are less commonly involved in research than their non-disabled peers. This review investigated how disabled children have been involved as research partners; specifically how they have been recruited, the practicalities and challenges of involvement and how these have been overcome, and impacts of involvement for research, and disabled children and young people. The INVOLVE definition of involvement and the Equality and Human Rights Commission definition of disability were used. Relevant bibliographic databases were searched. Websites were searched for grey literature. Included studies had involved disabled children and young people aged 5-25 years in any study design. Reviews, guidelines, reports and other documents from the grey literature were eligible for inclusion. Twenty-two papers were included: seven reviews, eight original research papers, three reports, three guidelines and one webpage. Nine examples of involvement were identified. Recommendations included developing effective communication techniques, using flexible methods that can be adapted to needs and preferences, and ensuring that sufficient support and funding is available for researchers undertaking involvement. Positive impacts of involvement for disabled children included increased confidence, self-esteem and independence. Positive impacts for research were identified. Involving disabled children in research can present challenges; many of these can be overcome with sufficient time, planning and resources. More needs to be done to find ways to involve those with non-verbal communication. Generally, few details were reported about disabled children and young people's involvement in studies, and the quality of evidence was low. Although a range of positive impacts were identified, the majority of these were authors' opinions rather

  16. Ethics in research involving prisoners.

    Science.gov (United States)

    Pont, Jörg

    2008-01-01

    Research involving prisoners repeatedly went astray during the last century, culminating in the cruel medical experiments inside the Nazi concentration camps that gave rise to the Nuremberg Code. However, prisoners continued to become victims of scientific exploitation by the rapidly evolving biomedical research industry. The common roots of these abuses were the flawed philosophy that the needs of the society outweigh the needs of the individual and the researchers' view that prisoners are cheap, easy to motivate and stable research subjects. Prisoners are vulnerable to exploitation and abuse by research because their freedom for consent can easily be undermined, and because of learning disabilities, illiteracy and language barriers prevailing within prisoner populations. Therefore, penal laws of some countries supported by a number of internationally agreed documents prohibit research involving prisoners completely. However, prisoners must also be regarded as vulnerable to the specific health problems in prisons, e.g. transmissible diseases, mental disorders and suicide - problems that need to be addressed by research involving prisoners. Additionally, the participation of prisoner patients in research they directly can benefit from should be provided. Hence, it must be a common objective to find the right balance between protection from exploitation and access to research beneficial to prisoners.

  17. Ethics, Ethical Human Research and Human Research Ethics Committees

    Science.gov (United States)

    Lindorff, Margaret

    2010-01-01

    Non-medical research involves the same issues of justice, beneficence, and respect for persons that apply to non-medical research. It also may involve risk of harm to participants, and conflicts of interest for researchers. It is therefore not possible to argue that such research should be exempt from ethical review. This paper argues that…

  18. Parallel experience: how art and art theory can inform ethics in human research.

    Science.gov (United States)

    Schwartz, L

    2003-12-01

    Trends in ethical research involving humans emphasise the importance of collaboration, of involving research subjects, alongside the researchers in the construction and implementation of research. This paper will explore parallels derived from another tradition of investigation of the human: art and art theory. An artist's inquiry into the problems of human research will be described, followed by the application of arguments from art theory to research practice. Recently artist Christine Borland has provided examples in which the lack of collaboration in research has caused injustice. Borland's work reflects these ethical dilemmas and questions the procedures and assumptions involved. In most cases the value of subject anonymity is called into question because it reduces the subjects' control over themselves. The application of art theory, which has already considered these problems, helps question and explore the ways in which the subject turned object of artistic or scientific interpretation can maintain some control and dignity.

  19. Human subject research: reporting ethics approval and informed consent in 3 chiropractic journals.

    Science.gov (United States)

    Lawrence, Dana J

    2011-11-01

    To date, there have been no reports of ethics board approval or informed consent within the chiropractic literature or within chiropractic research. The purpose of this study was to assess the reporting of ethics approval and informed consent in articles published during the 2008 volume year of 3 chiropractic research journals included in PubMed. A quantitative assessment of the articles published in each journal for the 2008 volume year was performed. Information collected included if the article involved human subject research, if it reported ethics board approval, and if informed consent was given to subjects. Data were collected as descriptive statistics (frequency counts and percentages). In aggregate, 50 articles of a total of 143 published involved human subject research (35%). 44 reported ethics board approval (88%), and 28 reported that informed consent had been obtained (56%). Forty-five percent of articles published in the Journal of Manipulative and Physiological Therapeutics involved human subject research (39/87), of which 95% reported ethics board approval (37/39) and 64% reported informed consent (25/39); 12.5% of articles from the Journal of the Canadian Chiropractic Association involved human subject research (5/40), of which 80% reported ethics board approval (4/5) and 40% reported informed consent (2/5); and 37.5% of articles published in Chiropractic and Osteopathy involved human subject research (6/16), of which 50% reported ethics board approval (3/6) and 17% reported informed consent (1/6). Overall, most articles reported ethics approval, and more than half reported consent. This was harmonious with research on this topic from other disciplines. This situation indicates a need for continued quality improvement and for better instruction and dissemination of information on these issues to researchers, to manuscript reviewers, to journal editors, and to the readers. Copyright © 2011 National University of Health Sciences. Published by Mosby

  20. Protection of the human research participant: A structured review

    African Journals Online (AJOL)

    related or social-science research involves a human participant. This ... quantitative studies, as well as review articles, were included, to enhance ... In the study by Gremillion et al.,[7] comparison was made between .... research stakeholders, who took part in interviews and focus- .... Contact persons ... Face to face.

  1. Patient involvement in research priorities (PIRE)

    DEFF Research Database (Denmark)

    Piil, Karin; Jarden, Mary

    2016-01-01

    Introduction: Patient involvement in healthcare has expanded from the clinical practice setting to include collaboration during the research process. There has been a growing international interest in patient and public involvement in setting research priorities to reduce the risk of discrepancy...... between what patients with cancer and their relatives experience as important unanswered questions and those which are actually researched. This study aims to challenge the conventional research process by inviting patients with life-threatening cancer (primary malignant brain tumours or acute leukaemia......), relatives and patient organisations to join forces with clinical specialists and researchers to identify, discuss and prioritise supportive care and rehabilitation issues in future research. Methods and analysis: This is an exploratory qualitative study comprising two sets of three focus group interviews...

  2. Community Involvement in TB Research

    NARCIS (Netherlands)

    M. van der Werf (Marloes); S.G. Heumann (Silke); E.M.H. Mitchell

    2011-01-01

    textabstractWhile communities at risk have been both drivers and partners in HIV research, their important role in TB research is yet to be fully realized. Involvement of communities in tuberculosis care and prevention is currently on the international agenda. This creates opportunities and

  3. Enhancing public involvement in assistive technology design research.

    Science.gov (United States)

    Williamson, Tracey; Kenney, Laurence; Barker, Anthony T; Cooper, Glen; Good, Tim; Healey, Jamie; Heller, Ben; Howard, David; Matthews, Martin; Prenton, Sarah; Ryan, Julia; Smith, Christine

    2015-05-01

    To appraise the application of accepted good practice guidance on public involvement in assistive technology research and to identify its impact on the research team, the public, device and trial design. Critical reflection and within-project evaluation were undertaken in a case study of the development of a functional electrical stimulation device. Individual and group interviews were undertaken with lay members of a 10 strong study user advisory group and also research team members. Public involvement was seen positively by research team members, who reported a positive impact on device and study designs. The public identified positive impact on confidence, skills, self-esteem, enjoyment, contribution to improving the care of others and opportunities for further involvement in research. A negative impact concerned the challenge of engaging the public in dissemination after the study end. The public were able to impact significantly on the design of an assistive technology device which was made more fit for purpose. Research team attitudes to public involvement were more positive after having witnessed its potential first hand. Within-project evaluation underpins this case study which presents a much needed detailed account of public involvement in assistive technology design research to add to the existing weak evidence base. The evidence base for impact of public involvement in rehabilitation technology design is in need of development. Public involvement in co-design of rehabilitation devices can lead to technologies that are fit for purpose. Rehabilitation researchers need to consider the merits of active public involvement in research.

  4. Cinnamic Acid Is Partially Involved in Propolis Immunomodulatory Action on Human Monocytes

    Directory of Open Access Journals (Sweden)

    Bruno José Conti

    2013-01-01

    Full Text Available Propolis is a beehive product used in traditional medicine due to its biological properties. It shows a complex chemical composition including phenolics, such as cinnamic acid (Ci. The mechanisms of action of propolis have been the subject of research recently; however, the involvement of Ci on propolis activity was not investigated on immune cells. Ci effects were evaluated on human monocytes, assessing the expression of Toll-like receptors (TLRs, HLA-DR, and CD80. Cytokine production (TNF-α and IL-10 and the fungicidal activity of monocytes were evaluated as well. Data showed that Ci downregulated TLR-2, HLA-DR, and CD80 and upregulated TLR-4 expression by human monocytes. High concentrations of Ci inhibited both TNF-α and IL-10 production, whereas the same concentrations induced a higher fungicidal activity against Candida albicans. TNF-α and IL-10 production was decreased by blocking TLR-4, while the fungicidal activity of monocytes was not affected by blocking TLRs. These results suggest that Ci modulated antigen receptors, cytokine production, and the fungicidal activity of human monocytes depending on concentration, and TLR-4 may be involved in its mechanism of action. Ci seemed to be partially involved in propolis activities.

  5. Parent Involvement in Homework: A Research Synthesis

    Science.gov (United States)

    Patall, Erika A.; Cooper, Harris; Robinson, Jorgianne Civey

    2008-01-01

    New emphasis is being placed on the importance of parent involvement in children's education. In a synthesis of research on the effects of parent involvement in homework, a meta-analysis of 14 studies that manipulated parent training for homework involvement reveals that training parents to be involved in their child's homework results in (a)…

  6. The Society's Involvement in the Defense of Human Rights

    Science.gov (United States)

    Gerjuoy, Edward

    2015-04-01

    The history of the Society's involvement in the defense of human rights, a history of which the Society can be proud, will be summarized; the summary will include illustrative specific APS human rights defense actions in illustrative specific cases. As will be emphasized, the aforesaid involvement has been primarily through the activities of the APS Committee on International Freedom of Scientists (CIFS). It is noteworthy-and one of the reasons the Society can be proud-that CIFS is charged with ``monitoring concerns regarding human rights for scientists,'' not solely for physicists, and that CIFS indeed has sought to protect the human rights of nonphysicists.

  7. Human cloning, stem cell research. An Islamic perspective.

    Science.gov (United States)

    Al-Aqeel, Aida I

    2009-12-01

    The rapidly changing technologies that involve human subjects raise complex ethical, legal, social, and religious issues. Recent advances in the field of cloning and stem cell research have introduced new hopes for the treatment of serious diseases. But this promise has raised many complex questions. This field causes debate and challenge, not only among scientists but also among ethicists, religious scholars, governments, and politicians. There is no consensus on the morality of human cloning, even within specific religious traditions. In countries in which religion has a strong influence on political decision making, the moral status of the human embryo is at the center of the debate. Because of the inevitable consequences of reproductive cloning, it is prohibited in Islam. However, stem cell research for therapeutic purposes is permissible with full consideration, and all possible precautions in the pre-ensoulment stages of early fetus development, if the source is legitimate.

  8. Salutogenic service user involvement in nursing research: a case study.

    Science.gov (United States)

    Mjøsund, Nina Helen; Vinje, Hege Forbech; Eriksson, Monica; Haaland-Øverby, Mette; Jensen, Sven Liang; Kjus, Solveig; Norheim, Irene; Portaasen, Inger-Lill; Espnes, Geir Arild

    2018-05-12

    The aim was to explore the process of involving mental healthcare service users in a mental health promotion research project as research advisors and to articulate features of the collaboration which encouraged and empowered the advisors to make significant contributions to the research process and outcome. There is an increasing interest in evaluating aspects of service user involvement in nursing research. Few descriptions exist of features that enable meaningful service user involvement. We draw on experiences from conducting research which used the methodology interpretative phenomenological analysis to explore how persons with mental disorders perceived mental health. Aside from the participants in the project, five research advisors with service user experience were involved in the entire research process. We applied a case study design to explore the ongoing processes of service user involvement. Documents and texts produced while conducting the project (2012-2016), as well as transcripts from multistage focus group discussions with the research advisors, were analysed. The level of involvement was dynamic and varied throughout the different stages of the research process. Six features: leadership, meeting structure, role clarification, being members of a team, a focus on possibilities and being seen and treated as holistic individuals, were guiding principles for a salutogenic service user involvement. These features strengthened the advisors' perception of themselves as valuable and competent contributors. Significant contributions from research advisors were promoted by facilitating the process of involvement. A supporting structure and atmosphere were consistent with a salutogenic service user involvement. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

  9. Classification system for reporting events involving human malfunctions

    DEFF Research Database (Denmark)

    Rasmussen, Jens; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting indus-trial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify "human error......" rates. The classification system has a multifacetted non-hierarchical struc-ture and its compatibility with Isprals ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors oriented......, are listed with their respective subcategories, and comments are given. Underlying models of human data processes and their typical malfunc-tions and of a human decision sequence are described....

  10. Classification system for reporting events involving human malfunctions

    International Nuclear Information System (INIS)

    Rasmussen, J.; Pedersen, O.M.; Mancini, G.; Carnino, A.; Griffon, M.; Gagnolet, P.

    1981-03-01

    The report describes a set of categories for reporting industrial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify ''human error'' rates. The classification system has a multifacetted non-hierarchial structure and its compatibility with Ispra's ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors oriented, are listed with their respective subcategories, and comments are given. Underlying models of human data processes and their typical malfunctions and of a human decision sequence are described. (author)

  11. Human Participants in Engineering Research: Notes from a Fledgling Ethics Committee.

    Science.gov (United States)

    Koepsell, David; Brinkman, Willem-Paul; Pont, Sylvia

    2015-08-01

    For the past half-century, issues relating to the ethical conduct of human research have focused largely on the domain of medical, and more recently social-psychological research. The modern regime of applied ethics, emerging as it has from the Nuremberg trials and certain other historical antecedents, applies the key principles of: autonomy, respect for persons, beneficence, non-maleficence, and justice to human beings who enter trials of experimental drugs and devices (Martensen in J Hist Med Allied Sci 56(2):168-175, 2001). Institutions such as Institutional Review Boards (in the U.S.) and Ethics Committees (in Europe and elsewhere) oversee most governmentally-funded medical research around the world, in more than a hundred nations that are signers of the Declaration of Helsinki (World Medical Association 2008). Increasingly, research outside of medicine has been recognized to pose potential risks to human subjects of experiments. Ethics committees now operate in the US, Canada, the U.K. and Australia to oversee all governmental-funded research, and in other jurisdictions, the range of research covered by such committees is expanding. Social science, anthropology, and other fields are falling under more clear directives to conduct a formal ethical review for basic research involving human participants (Federman et al. in Responsible research: a systems approach to protecting research participants. National Academies Press, Washington, 2003, p. 36). The legal and institutional response for protecting human subjects in the course of developing non-medical technologies, engineering, and design is currently vague, but some universities are establishing ethics committees to oversee their human subjects research even where the experiments involved are non-medical and not technically covered by the Declaration of Helsinki. In The Netherlands, as in most of Europe, Asia, Latin America, or Africa, no laws mandate an ethical review of non-medical research. Yet, nearly 2

  12. Methodological issues involved in conducting qualitative research ...

    African Journals Online (AJOL)

    The purpose of this article is to describe the methodological issues involved in conducting qualitative research to explore and describe nurses' experience of being directly involved with termination of pregnancies and developing guidelines for support for these nurses. The article points out the sensitivity and responsibility ...

  13. Predictive Mechanisms Are Not Involved the Same Way during Human-Human vs. Human-Machine Interactions: A Review

    Directory of Open Access Journals (Sweden)

    Aïsha Sahaï

    2017-10-01

    Full Text Available Nowadays, interactions with others do not only involve human peers but also automated systems. Many studies suggest that the motor predictive systems that are engaged during action execution are also involved during joint actions with peers and during other human generated action observation. Indeed, the comparator model hypothesis suggests that the comparison between a predicted state and an estimated real state enables motor control, and by a similar functioning, understanding and anticipating observed actions. Such a mechanism allows making predictions about an ongoing action, and is essential to action regulation, especially during joint actions with peers. Interestingly, the same comparison process has been shown to be involved in the construction of an individual's sense of agency, both for self-generated and observed other human generated actions. However, the implication of such predictive mechanisms during interactions with machines is not consensual, probably due to the high heterogeneousness of the automata used in the experimentations, from very simplistic devices to full humanoid robots. The discrepancies that are observed during human/machine interactions could arise from the absence of action/observation matching abilities when interacting with traditional low-level automata. Consistently, the difficulties to build a joint agency with this kind of machines could stem from the same problem. In this context, we aim to review the studies investigating predictive mechanisms during social interactions with humans and with automated artificial systems. We will start by presenting human data that show the involvement of predictions in action control and in the sense of agency during social interactions. Thereafter, we will confront this literature with data from the robotic field. Finally, we will address the upcoming issues in the field of robotics related to automated systems aimed at acting as collaborative agents.

  14. Ethics is for human subjects too: participant perspectives on responsibility in health research.

    Science.gov (United States)

    Cox, Susan M; McDonald, Michael

    2013-12-01

    Despite the significant literature as well as energy devoted to ethical review of research involving human subjects, little attention has been given to understanding the experiences of those who volunteer as human subjects. Why and how do they decide to participate in research? Is research participation viewed as a form of social responsibility or as a way of obtaining individual benefits? What if anything do research subjects feel they are owed for participation? And what do they feel that they owe the researcher? Drawing on in-depth individual interviews conducted in 2006 and 2007 with 41 subjects who participated in a variety of types of health research in Canada, this paper focuses on subject perspectives on responsibility in research. Highlighting the range of ways that subjects describe their involvement in research and commitments to being a 'good' subject, we present a typology of narratives that sheds new light on the diverse meanings of research participation. These narratives are not mutually exclusive or prescriptive but are presented as ideal types typifying a set of circumstances and values. As such, they collectively illuminate a range of motivations expressed by human subjects as well as potential sources of vulnerability. The typology adds a new dimension to the literature in this area and has significant implications for researchers seeking more human-subject centred approaches to research recruitment and retention, as well as research ethics boards trying to better anticipate the perspectives of prospective participants. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Administration of ionizing radiation to human subjects in medical research

    International Nuclear Information System (INIS)

    1985-01-01

    Any administration of ionizing radiation to human subjects for the purposes of diagnostic or therapeutic research involving either irradiation or the administration of radionuclides, should be undertaken only after approval by an institutional ethics committee. The ethics committee should obtain advice from a person experienced in radiation protection before granting approval. The research proposal must conform to regulatory requirements relating to the use of ionizing radiation

  16. Bioethical Principles of Biomedical Research Involving Animals

    Directory of Open Access Journals (Sweden)

    Bakir Mehić

    2011-08-01

    Full Text Available A major requirement both of national and international ethical codes for human experimentation, and of national legislation in many cases, is that new substances or devices should not be used for the first time on human beings unless previous tests on animals have provided a reasonable presumption of their safety. That is so called: Good Clinical Praxis (GCP. There are two international ethical codes intended principally for the guidance of countries or institutions that have not yet formulated their own ethical requirements for human experimentation: The Declaration of Helsinki of the World Medical Association and The Proposed International Guidelines for Biomedical Research Involving Human Subjects of the Council for International Organizations of Medical Sciences and the World Health Organization[1].Animal experimentation is fundamental to the biomedical sciences, not only for the advancement of specific vital processes, but also for the improvement of methods of prevention, diagnosis, and treatment of disease both in man and in animals. The use of animals is also indispensable for testing the potency and safety of biological substances used in human and veterinary medicine, as well as for determining the toxicity of the rapidly growing number of molecules that never existed before in nature and which may represent a hazard to health. This extensive exploitation by man of animals implies philosophical and moral problems that are not peculiar to their use for scientific purposes, and there are no objective ethical criteria by which to judge claims and counterclaims in such matters[2]. However, there is a consensus that „deliberate cruelty is repugnant”.While many countries have general laws or regulations imposing penalties for ill-treatment of animals, relatively few make specific provision for their use for scientific purposes. Because of differing legal systems and cultural backgrounds there are varying approaches to the use of

  17. Classification system for reporting events involving human malfunctions

    International Nuclear Information System (INIS)

    Rasmussen, J.; Pedersen, O.M.; Mancini, G.

    1981-01-01

    The report describes a set of categories for reporting industrial incidents and events involving human malfunction. The classification system aims at ensuring information adequate for improvement of human work situations and man-machine interface systems and for attempts to quantify ''human error'' rates. The classification system has a multifacetted non-hierarchical structure and its compatibility with Ispra's ERDS classification is described. The collection of the information in general and for quantification purposes are discussed. 24 categories, 12 of which being human factors-oriented, are listed with their respective subcategories, and comments are given. Underlying models of human data process and their typical malfuntions and of a human decision sequence are described. The work reported is a joint contribution to the CSNI Group of Experts on Human Error Data and Assessment

  18. Ethical issues in Alzheimer's disease research involving human subjects.

    Science.gov (United States)

    Davis, Dena S

    2017-12-01

    As we aggressively pursue research to cure and prevent Alzheimer's disease, we encounter important ethical challenges. None of these challenges, if handled thoughtfully, would pose insurmountable barriers to research. But if they are ignored, they could slow the research process, alienate potential study subjects and do damage to research recruits and others. These challenges are (1) the necessity of very large cohorts of research subjects, recruited for lengthy studies, probably ending only in the subjects' death; (2) the creation of cohorts of 'study ready' volunteers, many of whom will be competent to consent at the beginning of the process, but move into cognitive impairment later; (3) reliance on adaptive trial design, creating challenges for informed consent, equipoise and justice; (4) the use of biomarkers and predictive tests that describe risk rather than certainty, and that can threaten participants' welfare if the information is obtained by insurance companies or long-term care providers; (5) the use of study partners that creates unique risks of harm to the relationship of subject and study partner. We need greater attention, at all levels, to these complex ethical issues. Work on these issues should be included in research plans, from the federal to the local, and should be supported through NIH in the same way that it supported work on the ethical, legal and social implications of genetic research. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  19. Open access monographs: a humanities research perspective

    Directory of Open Access Journals (Sweden)

    Dr Jim Cheshire

    2014-04-01

    Full Text Available This article discusses the thoughts of a humanities researcher in relation to open access (OA publishing. Digital media have dramatically improved access to historic texts but library e-books are frustrating due to software and loan arrangements. Authors of illustrated books risk losing control of book design, although new media offer opportunities to improve image quality and access. Alfred Tennyson's career shows that authors have been sensitive about the physical form of their work since the Victorian period and ignoring the material significance of the book could make us overlook the fundamental changes that the e-book represents. Monographs retain value as a way of evaluating substantive research projects and those published through the OA process will have great advantages over the commercial e-book. ‘Green’ OA publishing is impractical for humanities scholars and funded ‘gold’ OA publishing is likely to involve a labour-intensive application process.

  20. Leashes and Lies: Navigating the Colonial Tensions of Institutional Ethics of Research Involving Indigenous Peoples in Canada

    Directory of Open Access Journals (Sweden)

    Martha L. Stiegman

    2015-06-01

    Full Text Available Ethical standards of conduct in research undertaken at Canadian universities involving humans has been guided by the three federal research funding agencies through the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (or TCPS for short since 1998. The statement was revised for the first time in 2010 and is now commonly referred to as the TCPS2, which includes an entire chapter (Chapter 9 devoted to the subject of research involving First Nations, Inuit, and Métis peoples of Canada. While the establishment of TCPS2 is an important initial step on the long road towards decolonizing Indigenous research within the academy, our frustrations—which echo those of many colleagues struggling to do research “in a good way” (see, for example, Ball & Janyst 2008; Bull, 2008; Guta et al., 2010 within this framework—highlight the urgent work that remains to be done if university-based researchers are to be enabled by establishment channels to do “ethical” research with Aboriginal peoples. In our (and others’ experience to date, we seem to have been able to do research in a good way, despite, not because of the TCPS2 (see Castleden et al., 2012. The disconnect between the stated goals of TCPS2, and the challenges researchers face when attempting to navigate how individual, rotating members of REBs interpret the TPCS2 and operate within this framework, begs the question: Wherein lies the disconnect? A number of scholars are currently researching this divide (see for example see Guta et al. 2010; Flicker & Worthington, 2011; and Guta et al., 2013. In this editorial, we offer an anecdote to illustrate our experience regarding some of these tensions and then offer reflections about what might need to change for the next iteration of the TCPS.

  1. 21 CFR 56.110 - Expedited review procedures for certain kinds of research involving no more than minimal risk...

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 1 2010-04-01 2010-04-01 false Expedited review procedures for certain kinds of research involving no more than minimal risk, and for minor changes in approved research. 56.110 Section 56.110 Food and Drugs FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL...

  2. The irradiation of human volunteer subjects in research

    International Nuclear Information System (INIS)

    Rosen, R.

    1980-01-01

    In medical research radiation is sometimes used to obtain data from healthy individuals. These subjects gain no specific benefit from the research. To safeguard their welfare, constraints are imposed on the dose to be received, on the selection of volunteer subjects, on ensuring their understanding of the procedures and risks, and on obtaining their free consent to participate. The research proposals are assessed by peer review prior to being approved by the host institution. The first example presented describes the use of diagnostic radiography to obtain in vivo data on the femur bone. Conservative dosimetry indicates an expected dose-equivalent per film of 0.5 mSv in bone and 0.18 mSv in bone marrow and gonad tissue. The critical organ total dose-equivalent is estimated to be 7% of the dose-equivalent limit for a volunteer. The second example involves the internal administration of radioactive tracers. Dosimetric calculations indicate an expected whole-body dose-equivalent of 0.5 mSv in the case of C-14 and 0.37 mSv in the case of H-3, these values bejng 10% and 7% of the relevant dose-equivalent limit. Both proposals were given conditional approval. In the generalized research use of volunteer human subjects the rights of the subject, the investigator and the institution need to be protected. At the University of New South Wales procedures have been introduced to govern all experjmental procedures involving human subjects. Some interesting problems which have arisen are discussed. (author)

  3. Human Research Program Integrated Research Plan. Revision A January 2009

    Science.gov (United States)

    2009-01-01

    The Integrated Research Plan (IRP) describes the portfolio of Human Research Program (HRP) research and technology tasks. The IRP is the HRP strategic and tactical plan for research necessary to meet HRP requirements. The need to produce an IRP is established in HRP-47052, Human Research Program - Program Plan, and is under configuration management control of the Human Research Program Control Board (HRPCB). Crew health and performance is critical to successful human exploration beyond low Earth orbit. The Human Research Program (HRP) is essential to enabling extended periods of space exploration because it provides knowledge and tools to mitigate risks to human health and performance. Risks include physiological and behavioral effects from radiation and hypogravity environments, as well as unique challenges in medical support, human factors, and behavioral or psychological factors. The Human Research Program (HRP) delivers human health and performance countermeasures, knowledge, technologies and tools to enable safe, reliable, and productive human space exploration. Without HRP results, NASA will face unknown and unacceptable risks for mission success and post-mission crew health. This Integrated Research Plan (IRP) describes HRP s approach and research activities that are intended to address the needs of human space exploration and serve HRP customers and how they are integrated to provide a risk mitigation tool. The scope of the IRP is limited to the activities that can be conducted with the resources available to the HRP; it does not contain activities that would be performed if additional resources were available. The timescale of human space exploration is envisioned to take many decades. The IRP illustrates the program s research plan through the timescale of early lunar missions of extended duration.

  4. How to Cope with the Rare Human Error Events Involved with organizational Factors in Nuclear Power Plants

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Sa Kil; Luo, Meiling; Lee, Yong Hee [Korea Atomic Research Institute, Daejeon (Korea, Republic of)

    2014-10-15

    The current human error guidelines (e.g. US DOD handbooks, US NRC Guidelines) are representative tools to prevent human errors. These tools, however, have limits that they do not adapt all operating situations and circumstances such as design base events. In other words, these tools are only adapted foreseeable standardized operating situations and circumstances. In this study, our research team proposed an evidence-based approach such as UK's safety case to coping with the rare human error events such as TMI, Chernobyl, Fukushima accidents. These accidents are representative events involved with rare human errors. Our research team defined the 'rare human errors' as the follow three characterized events; Extremely low frequency Extremely high complicated structure Extremely serious damage of human life and property A safety case is a structured argument, supported by evidence, intended to justify that a system is acceptably safe. The definition by UK defense standard 00-56 issue 4 states that such an evidence-based approach can be contrast with a prescriptive approach to safety certification, which require safety to be justified using a prescribed process. Safety managements and safety regulatory activities based on safety case are effective to control organizational factors in terms of integrated safety management. Especially safety issues relevant with public acceptance are useful to provide practical evidences to the public reasonably. European Union including UK has developed the concept of engineered safety management system to deal with public acceptance using the safety case. In Korea nuclear industry, the Korean Atomic Research Institute has firstly performed a basic research to adapt the safety case in the field of radioactive waste according to the IAEA SSG-23(KAERI/TR-4497, 4531). Excepting the radioactive waste, there is no try to adapt the safety case yet. Most incidents and accidents involved human during operating NPPs have a tendency

  5. How to Cope with the Rare Human Error Events Involved with organizational Factors in Nuclear Power Plants

    International Nuclear Information System (INIS)

    Kim, Sa Kil; Luo, Meiling; Lee, Yong Hee

    2014-01-01

    The current human error guidelines (e.g. US DOD handbooks, US NRC Guidelines) are representative tools to prevent human errors. These tools, however, have limits that they do not adapt all operating situations and circumstances such as design base events. In other words, these tools are only adapted foreseeable standardized operating situations and circumstances. In this study, our research team proposed an evidence-based approach such as UK's safety case to coping with the rare human error events such as TMI, Chernobyl, Fukushima accidents. These accidents are representative events involved with rare human errors. Our research team defined the 'rare human errors' as the follow three characterized events; Extremely low frequency Extremely high complicated structure Extremely serious damage of human life and property A safety case is a structured argument, supported by evidence, intended to justify that a system is acceptably safe. The definition by UK defense standard 00-56 issue 4 states that such an evidence-based approach can be contrast with a prescriptive approach to safety certification, which require safety to be justified using a prescribed process. Safety managements and safety regulatory activities based on safety case are effective to control organizational factors in terms of integrated safety management. Especially safety issues relevant with public acceptance are useful to provide practical evidences to the public reasonably. European Union including UK has developed the concept of engineered safety management system to deal with public acceptance using the safety case. In Korea nuclear industry, the Korean Atomic Research Institute has firstly performed a basic research to adapt the safety case in the field of radioactive waste according to the IAEA SSG-23(KAERI/TR-4497, 4531). Excepting the radioactive waste, there is no try to adapt the safety case yet. Most incidents and accidents involved human during operating NPPs have a tendency

  6. Supporting public involvement in research design and grant development: a case study of a public involvement award scheme managed by a National Institute for Health Research (NIHR) Research Design Service (RDS).

    Science.gov (United States)

    Boote, Jonathan D; Twiddy, Maureen; Baird, Wendy; Birks, Yvonne; Clarke, Clare; Beever, Daniel

    2015-10-01

    It is good practice for the public to be involved in developing health research. Resources should be available for researchers to fund the involvement of the public in the development of their grants. To describe a funding award scheme to support public involvement in grant development, managed by an NIHR Research Design Service (RDS). Case examples of how the award contributed to successful grant applications and findings from a recent evaluation of the scheme are presented. A case study of resource provision to support public involvement activities in one region of England. University and NHS-based researchers, and members of the public. Between 2009 and 2012, the RDS approved 45 public involvement funding awards (totalling nearly £19,000). These awards contributed to 27 submitted applications at the time of writing, of which 11 were successful (totalling over £7.5 million). The evaluation revealed difficulties encountered by some researchers when involving the public in grant development, which led to suggestions about how the scheme could be improved. This award scheme represents an efficient method of providing researchers with resources to involve the public in grant development and would appear to represent good value for money. © 2013 John Wiley & Sons Ltd.

  7. The impact of consumer involvement in research: an evaluation of consumer involvement in the London Primary Care Studies Programme.

    Science.gov (United States)

    Wyatt, Katrina; Carter, Mary; Mahtani, Vinita; Barnard, Angela; Hawton, Annie; Britten, Nicky

    2008-06-01

    The value of consumer involvement in health services research is widely recognized. While there is a growing body of evidence about the principles of good consumer involvement, there is little research about the effect that involvement can have on the research. This evaluation assessed the level and impact of consumer involvement in the London Primary Care Studies Programme (LPCSP), all of whose individual projects had to demonstrate substantial involvement as a condition of funding. To evaluate consumer involvement in the LPSCP and understand what impact consumers had on the research process and outcomes. A multi-method case study approach was undertaken, using survey techniques, interviews, focus groups, observation and scrutiny of written documents. The overall data set comprised 61 questionnaires, 44 semi-structured interviews, 2 focus groups and 15 hours of observation of meetings. Eleven primary care-based research projects which together made up the LPCSP. An in-depth description of consumer involvement in the Programme was produced. Nine projects had consumers as co-applicants, four projects had been completed before the evaluation began and one was still ongoing at the time of the evaluation. Of the eight projects which have produced final reports, all met their aims and objectives. Consumers had had an additional impact in the research, in the initial design of the study, in recruitment of the research subjects, in developing data collection tools, in collecting the data, in analysis and disseminating the findings. Consumer involvement in National Health Service research is a relatively recent policy development and while there is an increasing amount of literature about how and why consumers should be involved in research, there is less evidence about the impact of such involvement. This evaluation provides evidence about the impact that consumers have not only on the research process but also on the outcomes of the research.

  8. Why the moratorium on human-animal chimera research should not be lifted.

    Science.gov (United States)

    Moy, Alan

    2017-08-01

    The National Institutes of Health (NIH) announced its plans to lift its moratorium on funding research that involves injecting human embryonic stem cells into animal embryos, which would allow for the creation of part-human and part-animal organisms known as chimeras. The NIH allowed only one month to receive public comments in the midst of a presidential election campaign. Lifting the moratorium means that, for the first time, the federal government will begin spending taxpayer dollars on the creation and manipulation of new organisms that would blur the line between humans and animals. Interestingly, this government effort is creating an uncommon coalition between pro-life groups and animal rights activists that oppose this medical research on ethical grounds; the former seeking to ensure the welfare of human embryos and the latter seeking to protect the well-being of animals. Unlike the issue of abortion, this research is complex. Yet, it is important that the pro-life laity and clergy be adequately informed on some of the basic science and ethics that surround this research. To fully understand why this research is unethical and why the NIH is pursuing this particular research, it is important to understand the ethical tenets governing human-subject research and why secular scientists are pursuing this scientific field.

  9. Ethical Issues Surrounding the Use of Modern Human Remains for Research in South Africa.

    Science.gov (United States)

    Briers, N; Dempers, J J

    2017-02-01

    Chapter 8 of the South African National Health Act 61 of 2003 (NHA) that deals with the donation of human tissue was promulgated in 2012. The new Act is perceived to impose restrictions on low-risk research involving human remains. This study aimed to identify the issues raised by a research ethics committee (REC) when reviewing protocols where human remains are used as data source. REC minutes from 2009 to 2014 were reviewed, and issues raised by the committee were categorized. In total, 127 protocols submitted to the committee over 6 years involved human remains. Queries relating to science (22.2%) and administration (18.9%) were the most common, whereas queries relating to legal issues constituted only 10.2%. Ethical issues centered on informed consent regarding sensitive topics such as HIV, DNA, and deceased children. The change in legislation did not change the number or type of legal issues identified by the REC.

  10. The Significance of Benefit Perceptions for the Ethics of HIV Research Involving Adolescents in Kenya.

    Science.gov (United States)

    Rennie, Stuart; Groves, Allison K; Hallfors, Denise Dion; Iritani, Bonita J; Odongo, Fredrick S; Luseno, Winnie K

    2017-10-01

    Assessment of benefits is traditionally regarded as crucial to the ethical evaluation of research involving human participants. We conducted focus group discussions (FGDs) with health and other professionals engaged with adolescents, caregivers/parents, and adolescents in Siaya County, Kenya, to solicit opinions about appropriate ways of conducting HIV research with adolescents. Our data revealed that many focus group participants have a profoundly positive conception of participation in health research, including studies conferring seemingly few benefits. In this article, we identify and analyze five different but interrelated types of benefits as perceived by Kenyan adolescent and adult stakeholders in HIV research, and discuss their ethical significance. Our findings suggest that future empirical and conceptual research should concentrate on factors that may trigger researcher obligations to improve benefit perceptions among research participants.

  11. Radiation risk statement in the participant information for a research protocol that involves exposure to ionising radiation

    International Nuclear Information System (INIS)

    Caon, Martin

    2005-01-01

    A Human Research Ethics Committee (HREC) is required to scrutinise the protocols of clinical drug trials that recruit patients as participants. If the study involves exposing the participants to ionizing radiation the information provided to the participant should contain a radiation risk statement that is understandable by the Committee and the participant. The information that should be included in the risk statement is available from a variety of published sources and is discussed. The ARPANSA Code of Practice Exposure of Humans to Ionizing Radiation for Research Purposes (2005) states explicitly what the responsibilities of the researcher and the HREC are. Some research protocols do not provide the information required by good radiation protection practice and explicitly called for by the Code. Nine points (including: state that ionizing radiation is involved; that the radiation is additional to standard care; the effective dose to be received; the dose compared to natural background; the dose to the most exposed organs; a statement of risk; the benefits accruing from the exposure; ask the participant about previous exposures; name a contact person from whom information may be sought) that should be considered for inclusion in the participant information are presented and discussed. An example of a radiation risk statement is provided

  12. Accreditation of human research protection program: An Indian perspective

    Directory of Open Access Journals (Sweden)

    K L Bairy

    2012-01-01

    Full Text Available With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can have, that subjects are duly compensated, and credible data generated. Most importantly, each institution/hospital should have a strong Human Research Protection Program to safe guard the trial subjects. In order to look at research with a comprehensive objective approach, there is a need for a formal auditing and review system by a recognized body. As of now, only the sponsors are monitoring/auditing their respective trials; however, there is an increasing need to perform a more detailed review and assessment of processes of the institution and the Ethics Committee. This challenge can be addressed by going for accreditation by a reputed association that encompasses-the institutions, the ethics committees, and researcher/research staff. Starting their journey for the accreditation process in late 2010, Kasturba Medical College and Hospital [KMC], Manipal, and Manipal Hospital Bangalore [MHB] received full Association for the Accreditation of Human Research Protection Programs (AAHRPP accreditation in Dec 2011-a first in India. This article delves into the steps involved in applying for AAHRPP accreditation from an Indian Perspective, the challenges, advantages, and testimonials from the two hospitals on the application experience and how the accreditation has improved the Human Research Protection Program at these hospitals.

  13. Where does New Zealand stand on permitting research on human embryos?

    Science.gov (United States)

    Jones, D Gareth

    2014-08-01

    In many respects New Zealand has responded to the assisted reproductive technologies (ARTs) as positively as many comparable societies, such as Australia and the UK. Consequently, in vitro fertilisation (IVF) and pre-implantation genetic diagnosis (PGD) are widely available, as is non-commercial surrogacy utilising IVF. These developments have been made possible by the Human Assisted Reproductive Technology (HART) Act 2004, overseen by its two committees, the Advisory Committee on Assisted Reproductive Technology (ACART) and the Ethics Committee (ECART). However, New Zealand stands apart from many of these other societies by the lack of permission for scientists to conduct research using human embryos. There is no doubt this reflects strongly held viewpoints on the part of some that embryos should be protected and not exploited. Legitimate as this stance is, the resulting situation is problematic when IVF is already designated as an established procedure. This is because the development of IVF involved embryo research, and continuing improvements in procedures depend upon ongoing embryo research. While prohibition of research on human embryos gives the impression of protecting embryos, it fails to do this and also fails to enhance the health and wellbeing of children born using IVF. This situation will not be rectified until research is allowed on human embryos.

  14. 40 CFR 26.1703 - Prohibition of reliance on research involving intentional exposure of human subjects who are...

    Science.gov (United States)

    2010-07-01

    ...), nursing women, or children. 26.1703 Section 26.1703 Protection of Environment ENVIRONMENTAL PROTECTION... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Prohibition of reliance on research... intentional exposure of human subjects who are pregnant women (and therefore their fetuses), nursing women, or...

  15. An evolving research agenda for human-coastal systems

    Science.gov (United States)

    Lazarus, Eli D.; Ellis, Michael A.; Brad Murray, A.; Hall, Damon M.

    2016-03-01

    Within the broad discourses of environmental change, sustainability science, and anthropogenic Earth-surface systems, a focused body of work involves the coupled economic and physical dynamics of developed shorelines. Rapid rates of change in coastal environments, from wetlands and deltas to inlets and dune systems, help researchers recognize, observe, and investigate coupling in natural (non-human) morphodynamics and biomorphodynamics. This same intrinsic quality of fast-paced change also makes developed coastal zones exemplars of observable coupling between physical processes and human activities. In many coastal communities, beach erosion is a natural hazard with economic costs that coastal management counters through a variety of mitigation strategies, including beach replenishment, groynes, revetments, and seawalls. As cycles of erosion and mitigation iterate, coastline change and economically driven interventions become mutually linked. Emergent dynamics of two-way economic-physical coupling is a recent research discovery. Having established a strong theoretical basis, research into coupled human-coastal systems has passed its early proof-of-concept phase. This paper frames three major challenges that need resolving in order to advance theoretical and empirical treatments of human-coastal systems: (1) codifying salient individual and social behaviors of decision-making in ways that capture societal actions across a range of scales (thus engaging economics, social science, and policy disciplines); (2) quantifying anthropogenic effects on alongshore and cross-shore sediment pathways and long-term landscape evolution in coastal zones through time, including direct measurement of cumulative changes to sediment cells resulting from coastal development and management practices (e.g., construction of buildings and artificial dunes, bulldozer removal of overwash after major storms); and (3) reciprocal knowledge and data exchange between researchers in coastal

  16. Isocyanates and human health: Multi-stakeholder information needs and research priorities

    Science.gov (United States)

    Lockey, JE; Redlich, CA; Streicher, R; Pfahles-Hutchens, A; Hakkinen, PJ; Ellison, GL; Harber, P; Utell, M; Holland, J; Comai, A; White, Marc

    2014-01-01

    Objective Outline the knowledge gaps and research priorities identified by a broad-base of stakeholders involved in the planning and participation of an international conference and research agenda workshop on isocyanates and human health held in Potomac, Maryland in April 2013. Methods A multi-modal iterative approach was employed for data collection including pre-conference surveys, review of a 2001 consensus conference on isocyanates, oral and poster presentations, focused break-out sessions, panel discussions and post-conference research agenda workshop. Results Participants included representatives of consumer and worker health, health professionals, regulatory agencies, academic and industry scientists, labor, and trade associations. Conclusions Recommendations were summarized regarding knowledge gaps and research priorities in the following areas: worker and consumer exposures; toxicology, animal models, and biomarkers; human cancer risk; environmental exposure and monitoring; and respiratory epidemiology and disease, and occupational health surveillance. PMID:25563538

  17. Ethical issues when involving people newly diagnosed with dementia in research.

    Science.gov (United States)

    Holland, Suzanne; Kydd, Angela

    2015-03-01

    To discuss the methodological and ethical review challenges encountered by researchers who want to enable people with dementia to be involved in research. There has been increasing recognition of the importance of involving people with dementia in research. However, an argument has centred on the protection of these vulnerable clients versus their freedom to be involved as participants in research. People with dementia do have the right to have their experiences explored. Involving this client group in research is essential to gain a true understanding of their needs. The lead author's experience of conducting a study in which people newly diagnosed with dementia were recruited as research participants. An interpretive phenomenological approach was adopted during this qualitative study, with data collected by means of one to one interviews with people newly diagnosed with dementia. This study was completed within the set timeframe, but a large part of the work was spent gaining ethical approval. This meant that the timeframe of the study period was reduced and as a result, it was only possible to recruit three participants. However, people with dementia are perhaps one of the most vulnerable client groups and it is only right that they should not be subjected to harm. Ethical review is an important part of research. Meeting the ethical requirements of research involving people with dementia requires time and careful preparation to ensure that researchers safeguard the interests of this vulnerable client group, while also allowing the participants the opportunity to exercise their autonomy to their fullest potential. Conducting research that involves people with dementia may be time consuming, but it is only fair that this client group are afforded the freedom to be involved in research. This small time-limited study points to the need for larger pilot studies to hear from individuals what needs they have following a diagnosis of dementia.

  18. Ethical issues in research involving children and young people

    International Nuclear Information System (INIS)

    Scally, Andy

    2014-01-01

    This article identifies the key ethical issues that need to be addressed in any research study involving children and young people, accessed through the NHS. It makes specific reference to the Declaration of Helsinki and to additional guidance developed for researchers from a variety of disciplines, both within healthcare and in other fields of study. The focus of the paper is on defining the key ethical issues, identifying the complexities in the legislative framework underpinning research involving this patient group and offering practical advice on when, and how, ethical approval needs to be sought

  19. African Americans' opinions about human-genetics research.

    Science.gov (United States)

    Achter, Paul; Parrott, Roxanne; Silk, Kami

    2004-03-01

    Research on attitudes toward genetics and medicine registers skepticism among minority communities, but the reasons for this skepticism are not well known. In the past, studies linked mistrust of the medical system to historical ethics violations involving minority groups and to suspicions about ideological premise and political intent. To assess public knowledge, attitudes, and behavior regarding human-genetics research, we surveyed 858 Americans onsite in four community settings or online in a geographically nonspecific manner. Compared to participants as a whole, African Americans were significantly more likely to believe that clinical trials might be dangerous and that the federal government knowingly conducted unethical research, including studies in which risky vaccines were administered to prison populations. However, African Americans were also significantly more likely to believe that the federal government worked to prevent environmental exposure to toxicants harmful to people with genetic vulnerabilities. Our data suggest that most Americans trust government to act ethically in sponsoring and conducting research, including genetics research, but that African Americans are particularly likely to see government as powerfully protective in some settings yet selectively disingenuous in others.

  20. INVOLVING CHILDREN AND THEIR PARENTS IN RESEARCH DESIGN.

    Science.gov (United States)

    Hibberd, Suzannah

    2016-09-01

    Article 12 of the UN Convention on the Rights of the Child, states that children should be involved in decisions that directly affect them.1 Research involving children should ensure that the opinions and assistance of children and young people is sought at the beginning of the project as their perspectives may influence all aspects of the research design. To describe the challenges recruiting paediatric patients and members of the public to consult on the design of a research project. Posters were put up around the Children's Hospital including pharmacy to recruit paediatric patients and parents to review a research proposal involving children with long-term conditions. There were two responses to the poster, a father and his 15 year old daughter, and a father with a 2 year old child. The father of the 15 year old attended the initial planning meeting, unfortunately the 15 year old and the father of the 2 year old were unable to attend on the day although both agreed to participate in the project. The meeting gave the opportunity to explain the research proposal and answer questions. It was established that the lay team would review the lay summary, participant information leaflet (PIL), and questionnaires that would be sent to the participants. It was arranged that all further contact would be via email due to travel constraints.Patient and public involvement (PPI) in research requires the individuals to be reimbursed for their time. The National Institute for Health Research rate is £18.75 per hour. The lay team members were informed of this and were reimbursed for attending the planning meeting. The use of posters to recruit PPI into the research design had limited success. Since recruitment, the Children's Hospital has launched a youth partnership which may be able to assist in recruitment of lay team members in the future.The logistics of how to pay the lay team members needed to be resolved before their recruitment to ensure timely payment. A form has been

  1. Incorporating BDI Agents into Human-Agent Decision Making Research

    Science.gov (United States)

    Kamphorst, Bart; van Wissen, Arlette; Dignum, Virginia

    Artificial agents, people, institutes and societies all have the ability to make decisions. Decision making as a research area therefore involves a broad spectrum of sciences, ranging from Artificial Intelligence to economics to psychology. The Colored Trails (CT) framework is designed to aid researchers in all fields in examining decision making processes. It is developed both to study interaction between multiple actors (humans or software agents) in a dynamic environment, and to study and model the decision making of these actors. However, agents in the current implementation of CT lack the explanatory power to help understand the reasoning processes involved in decision making. The BDI paradigm that has been proposed in the agent research area to describe rational agents, enables the specification of agents that reason in abstract concepts such as beliefs, goals, plans and events. In this paper, we present CTAPL: an extension to CT that allows BDI software agents that are written in the practical agent programming language 2APL to reason about and interact with a CT environment.

  2. Exploring the characteristics, global distribution and reasons for retraction of published articles involving human research participants: a literature survey.

    Science.gov (United States)

    Li, Guowei; Kamel, Mariam; Jin, Yanling; Xu, Michael Kuan; Mbuagbaw, Lawrence; Samaan, Zainab; Levine, Mitchell Ah; Thabane, Lehana

    2018-01-01

    Article retraction is a measure taken by journals or authors where there is evidence of research misconduct or error, redundancy, plagiarism or unethical research. Recently, the retraction of scientific publications has been on the rise. In this survey, we aimed to describe the characteristics and distribution of retracted articles and the reasons for retractions. We searched retracted articles on the PubMed database and Retraction Watch website from 1980 to February 2016. The primary outcomes were the characteristics and distribution of retracted articles and the reasons for retractions. The secondary outcomes included how article retractions were handled by journals and how to improve the journal practices toward article retractions. We included 1,339 retracted articles. Most retracted articles had six authors or fewer. Article retraction was most common in the USA (26%), Japan (11%) and Germany (10%). The main reasons for article retraction were misconduct (51%, n = 685) and error (14%, n = 193). There were 66% (n = 889) of retracted articles having male senior or corresponding authors. Of the articles retracted after August 2010, 63% (n = 567) retractions were reported on Retraction Watch. Large discrepancies were observed in the ways that different journals handled article retractions. For instance, articles were completely withdrawn from some journals, while in others, articles were still available with no indication of retraction. Likewise, some retraction notices included a detailed account of the events that led to article retraction, while others only consisted of a statement indicating the article retraction. The characteristics, geographic distribution and reasons for retraction of published articles involving human research participants were examined in this survey. More efforts are needed to improve the consistency and transparency of journal practices toward article retractions.

  3. Service user involvement enhanced the research quality in a study using interpretative phenomenological analysis - the power of multiple perspectives.

    Science.gov (United States)

    Mjøsund, Nina Helen; Eriksson, Monica; Espnes, Geir Arild; Haaland-Øverby, Mette; Jensen, Sven Liang; Norheim, Irene; Kjus, Solveig Helene Høymork; Portaasen, Inger-Lill; Vinje, Hege Forbech

    2017-01-01

    The aim of this study was to examine how service user involvement can contribute to the development of interpretative phenomenological analysis methodology and enhance research quality. Interpretative phenomenological analysis is a qualitative methodology used in nursing research internationally to understand human experiences that are essential to the participants. Service user involvement is requested in nursing research. We share experiences from 4 years of collaboration (2012-2015) on a mental health promotion project, which involved an advisory team. Five research advisors either with a diagnosis or related to a person with severe mental illness constituted the team. They collaborated with the research fellow throughout the entire research process and have co-authored this article. We examined the joint process of analysing the empirical data from interviews. Our analytical discussions were audiotaped, transcribed and subsequently interpreted following the guidelines for good qualitative analysis in interpretative phenomenological analysis studies. The advisory team became 'the researcher's helping hand'. Multiple perspectives influenced the qualitative analysis, which gave more insightful interpretations of nuances, complexity, richness or ambiguity in the interviewed participants' accounts. The outcome of the service user involvement was increased breadth and depth in findings. Service user involvement improved the research quality in a nursing research project on mental health promotion. The interpretative element of interpretative phenomenological analysis was enhanced by the emergence of multiple perspectives in the qualitative analysis of the empirical data. We argue that service user involvement and interpretative phenomenological analysis methodology can mutually reinforce each other and strengthen qualitative methodology. © 2016 The Authors. Journal of Advanced Nursing Published by John Wiley & Sons Ltd.

  4. Pharmacists' views on involvement in pharmacy practice research: Strategies for facilitating participation.

    Science.gov (United States)

    Armour, Carol; Brillant, Martha; Krass, Ines

    2007-01-01

    In order for community pharmacy practice to continue to evolve, pharmacy practice research on potential new services is essential. This requires the active participation of community pharmacists. At present the level of involvement of community pharmacists in pharmacy practice research is minimal. To ascertain the attitudes of a group of research-experienced community pharmacists towards participating in research; to investigate the barriers and facilitators to participation; to identify potential strategies to increase the involvement of community pharmacists in research. A focus group was conducted with a purposive sample of 11 research-experienced community pharmacists. A pharmacist academic moderated the focus group using a semi-structured interview guide. The participants were asked about their attitudes towards research, previous involvement in research, barriers to their involvement and strategies to overcome these barriers. The session was audio-taped and notes were taken by an observer. Thematic analysis of the notes and audio-tape transcripts was conducted. Three themes emerged around pharmacists' attitudes towards research: pharmacists' perception of the purpose of research, pharmacists' motivation for involvement in research, and pharmacists' desired role in research. Barriers to research participation were grouped into four themes: pharmacists' mindset, communication, infrastructure (time, money and staff), and skills/knowledge. Strategies to address each of these barriers were suggested. Participants recognised the importance of research towards advancing their profession and this was a motivating factor for involvement in research. They perceived their role in research primarily as data collection. A series of practical strategies to overcome the barriers to participation were offered that researchers may wish to consider when promoting research outcomes and designing research projects.

  5. Pharmacists’ views on involvement in pharmacy practice research: Strategies for facilitating participation.

    Directory of Open Access Journals (Sweden)

    Armour C

    2007-06-01

    Full Text Available In order for community pharmacy practice to continue to evolve, pharmacy practice research on potential new services is essential. This requires the active participation of community pharmacists. At present the level of involvement of community pharmacists in pharmacy practice research is minimal. Objectives: To ascertain the attitudes of a group of research-experienced community pharmacists towards participating in research; to investigate the barriers and facilitators to participation; to identify potential strategies to increase the involvement of community pharmacists in research. Methods: A focus group was conducted with a purposive sample of 11 research-experienced community pharmacists. A pharmacist academic moderated the focus group using a semi-structured interview guide. The participants were asked about their attitudes towards research, previous involvement in research, barriers to their involvement and strategies to overcome these barriers. The session was audio-taped and notes were taken by an observer. Thematic analysis of the notes and audio-tape transcripts was conducted.Results: Three themes emerged around pharmacists’ attitudes towards research: pharmacists’ perception of the purpose of research, pharmacists’ motivation for involvement in research, and pharmacists’ desired role in research. Barriers to research participation were grouped into four themes: pharmacists’ mindset, communication, infrastructure (time, money and staff, and skills/knowledge. Strategies to address each of these barriers were suggested.Conclusions: Participants recognised the importance of research towards advancing their profession and this was a motivating factor for involvement in research. They perceived their role in research primarily as data collection. A series of practical strategies to overcome the barriers to participation were offered that researchers may wish to consider when promoting research outcomes and designing research

  6. E-Learning: A Means to Increase Learner Involvement in Research

    Science.gov (United States)

    de Beer, Marie; Mason, Roger B.

    2014-01-01

    This paper investigates a method for increasing the involvement of marketing fourth year learners in academic research, by encouraging greater participation in, and commitment to, their research project in the Applied Marketing IV subject. It is assumed that greater involvement will result in a greater pass rate. The main reasons for this lack of…

  7. Human cloning and stem cell research: engaging in the political process. (Legislation review: prohibition of Human Cloning Act 2002 and the research involving Human Embryos Act).

    Science.gov (United States)

    Skene, Loane

    2008-03-01

    Committees appointed by governments to inquire into specific policy issues often have no further role when the Committee's report is delivered to government, but that is not always so. This paper describes the activities of members of the Australian Committee on human cloning and embryo research (the Lockhart Committee) to inform Parliament and the community about the Committee's recommendations after its report was tabled in Parliament. It explains their participation in the political process as their recommendations were debated and amending legislation was passed by Parliament. It illustrates a method of communication about scientific and policy issues that explores people's concerns and what they 'need to know' to make a judgment; and then responds to questions they raise, with the aim of facilitating discussion, not arguing for one view. The paper considers whether this type of engagement and communication is appropriate and could be used in other policy discussions.

  8. [Experience of a research Ethics Committee and the challenges of the new Chilean legislation on research in human beings].

    Science.gov (United States)

    Oyarzún G, Manuel; Pinto C, María Eugenia; Raineri B, Gina G; Amigo, Hugo; Cifuentes O, Lucía; González, María Julieta; Horwitz, Nina; Marshall F, Claudia; Orellana V, Gricel

    2014-07-01

    The welfare of research participants must be guaranteed by international ethical standards. This article communicates the procedures of the Research Ethics Committee of the School of Medicine, University of Chile (CEISH). The new Chilean legislation on research in human beings is also discussed. Law 20.120: "On scientific research in human beings, its genome and forbidding human cloning" establishes the ethical principles that must be accomplished in every research involving human beings. Article 28 of the Law 20.584 "Regulation of the rights and duties of health care users", forbids the participation of handicapped people who cannot express their will in scientific research. Article 13 states that people not related directly with patient care cannot have access to his clinical records (with the exception of people with notarial authorization by the patient). CEISH proposes that, in case of people with intellectual deficiency, the decision to approve a scientific research should be analyzed on an individual basis. If the person is capable of expressing his or her will or has stated his or her consent beforehand, the research can be authorized. If the person cannot express his or her will, the scientific research cannot take place. In prospective studies, a consent from the patient and an authorization of the health authority should be required to access clinical records. In retrospective studies, consent should be obtained from the patient when personal information is going to be used. If the information is nameless, the consent can be disregarded.

  9. Clinical research involving minors in international and serbian regulations.

    Science.gov (United States)

    Planojević, Nina; Zivojinović, Dragica

    2013-07-01

    Participation in clinical trials can be useful for the health of a person, in who it is conducted, but it does not have to be - it can even be harmful. Therefore, primary motive to accept such risk is humanity and human wish to contribute to the progress of medicine; this is expressed by personal consent. The consent, however, can be an expression of personal humanity, and for this, it is not logical that someone can give consent on behalf of someone else, as it is done by a legally authorized representative on behalf of a minor. Therefore, authors raise 3 questions: What are the reasons to consider representative's consent acceptable? How should a model of regulations look like in order to provide the most complete possible protection to a minor? Is actual regulation of minors' position within international and Serbian law, analyzed here by authors for their specific solutions, acceptable? Representative's consent is acceptable only for therapeutic research, because these can bring benefits to everyone's health, including a minor in which those are conducted - this is an acceptable (secondary) motive of participation in the research. Expression of humanity on other's behalf, typical for non-therapeutic research, is not acceptable; this makes ban of minors' participation in non-therapeutic research more appropriate regulation model. International regulations are not in accordance to results presented in the paper for allowing participation of minors both in therapeutic and non-therapeutic research. Serbian regulation is closer to the most acceptable regulation model.

  10. Strategies for involving undergraduates in mentored research (Invited)

    Science.gov (United States)

    Marin-Spiotta, E.

    2013-12-01

    Early engagement in research can transform the undergraduate experience and has a positive effect on minority student recruitment to graduate school. Multiple strategies used to involve undergraduates in research at a large R1 university are presented. During my first four years as an assistant professor, my lab has hosted 14 undergraduates, 9 of them women and 4 of them Hispanic. Institutional support has been critical for undergraduate student involvement. UW supports a research program for incoming underrepresented students. An advantage of this program is very early research participation, with the opportunity for long-term training. One disadvantage is that many first year students have not yet identified their interests. The Biology major also requires students to complete an independent project, which culminates in a research symposium. Competitive research fellowships and grants are available for students to conduct work under faculty mentorship. We have been successful at keeping students on even when their majors are very different from our research discipline, mainly by providing flexibility and a welcoming lab environment. This mentoring culture is strongly fostered by graduate student interest and involvement with all undergraduates as well as active mentor training. By offering multiple pathways for involvement, we can accommodate students' changing schedules and priorities as well as changing lab needs. Students can volunteer, receive course credit, conduct an independent project or honors thesis, contribute to an existing project, do lab work or write a literature review, work with one mentor or on multiple projects. We often provide employment over the summer and subsequent semesters for continuing students. Some will increase their commitment over time and work more closely with me. Others reduce down to a few hours a week as they gain experience elsewhere. Most students stay multiple semesters and multiple years because they 'enjoy being in the

  11. Accessible Article: Involving People with Learning Disabilities in Research

    Science.gov (United States)

    Garbutt, Ruth; Tattersall, John; Dunn, Jo; Boycott-Garnett, Rachel

    2010-01-01

    This is an article that talks about our research about sex and relationships for people with learning disabilities. It talks about how people with learning disabilities have been fully involved in the research. (Contains 2 footnotes.)

  12. Human Research Program

    Data.gov (United States)

    National Aeronautics and Space Administration — Strategically, the HRP conducts research and technology development that: 1) enables the development or modification of Agency-level human health and performance...

  13. Managing Ethical Problems in Qualitative Research Involving Vulnerable Populations, Using a Pilot Study

    Directory of Open Access Journals (Sweden)

    Evalina van Wijk RN, PhD

    2013-02-01

    Full Text Available The purpose of the researcher's study was to examine the meaning that intimate partners of female rape victims attached to their lived experiences after the rape. The conduct of qualitative research concerning non-offending partners of female rape victims, however, often involves multifaceted ethical and practical challenges, which can be managed through the use of pilot studies. The pilot study described in this report had three objectives. The first was to pretest and refine the proposed method for locating, accessing, and recruiting intimate partners of female rape victims, within the first two weeks after the rape, for participation in a six-month longitudinal study. The second objective was to identify and prevent all possible risk factors in the proposed recruitment and data collection methods that could harm the participants' safety during the main study. The third objective was to determine the feasibility of the main study, in terms of the limited financial and human resources available. The pilot phase was valuable in identifying ethical and methodological problems during the recruitment of participants and collection of data. It allowed for methodological adjustments prior to the main study and confirmed the feasibility of the overall research design. A pilot, pretesting phase is therefore seen as an essential component of a qualitative study involving a vulnerable population.

  14. Student involvement and research for the nuclear industry

    International Nuclear Information System (INIS)

    Ginniff, M.E.

    1980-01-01

    Nuclear engineering is one of the modern and rapidly advancing technologies. Those already involved in it are continually updating their knowledge to keep abreast of the developments. Of course the sound basic principles of engineering still apply but the scene of application can be transformed in a few years. In fact, because of this, many engineers from more traditional industries often express the view that presently the total range of nuclear engineering is research and development. How can students be trained for such a rapidly advancing technology. Is not the answer early involvement. Effective early involvement for students can only come about by the close co-operation and involvement of the staff of universities and industry. The theme is developed. (author)

  15. Community perspectives on research consent involving vulnerable children in Western Kenya.

    Science.gov (United States)

    Vreeman, Rachel; Kamaara, Eunice; Kamanda, Allan; Ayuku, David; Nyandiko, Winstone; Atwoli, Lukoye; Ayaya, Samuel; Gisore, Peter; Scanlon, Michael; Braitstein, Paula

    2012-10-01

    Involving vulnerable pediatric populations in international research requires culturally appropriate ethical protections. We sought to use mabaraza, traditional East African community assemblies, to understand how a community in western Kenya viewed participation of children in health research and informed consent and assent processes. Results from 108 participants revealed generally positive attitudes towards involving vulnerable children in research, largely because they assumed children would directly benefit. Consent from parents or guardians was understood as necessary for participation while gaining child assent was not. They felt other caregivers, community leaders, and even community assemblies could participate in the consent process. Community members believed research involving orphans and street children could benefit these vulnerable populations, but would require special processes for consent.

  16. Methods for Involving Older People in Health Research-A Review of the Literature.

    Science.gov (United States)

    Schilling, Imke; Gerhardus, Ansgar

    2017-11-29

    Demographic change has increased the need for research on healthcare for older people. Recently there has been a growing awareness that research might benefit from actively involving patients and the public in study design and conduct. Besides empowering patients and democratizing research, involvement enhances the quality of research and the development of equitable healthcare solutions. Little is known about how to involve older people. This review aims to support scientists intending to involve older people in health research by systematically identifying and describing studies involving older people and analyzing associated facilitators and challenges. Old people were operationalized as people living with old-age-related conditions. We conducted a systematic search in PubMed, CINAHL (Cumulative Index to Nursing and Allied Health Literature), and Cochrane library for the period 2007 to July 2017 and also manually searched reference lists of the nine retrieved articles and other relevant sources. While involvement of older people in research is feasible, specific challenges related to this group need be taken into account. Strategies to enhance effective involvement comprise a thoughtful choice of location, use of visualization and accessible communication, building good relationships and flexible approaches. Further research is needed on the involvement of people in care homes or with vision, hearing or mobility limitations.

  17. [Ethics and laws related to human subject research].

    Science.gov (United States)

    Chiu, Hui-Ju; Lee, Ya-Ling; Chang, Su-Fen

    2011-10-01

    Advances in medical technology rely on human subject research to test the effects on real patients of unproven new drugs, equipment and techniques. Illegal human subject research happens occasionally and has led to subject injury and medical disputes. Familiarity with the laws and established ethics related to human subject research can minimize both injury and disputes. History is a mirror that permits reflection today on past experience. Discussing the Nuremberg Code, the Declaration of Helsinki and Belmont Report, this article describes the laws, ethics, history and news related to human subject research as well as the current definition and characteristics of human subject research. Increasing numbers of nurses serve as research nurses and participate in human subject research. The authors hope this article can increase research nurse knowledge regarding laws and ethics in order to protect human research subjects adequately.

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

    Science.gov (United States)

    Resnik, David B

    2017-01-01

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

  19. Bringing humanity into view: action research with Qatar's ambulance service.

    Science.gov (United States)

    Coleman, Gill; Wiggins, Liz

    2017-08-21

    Purpose The purpose of this paper is to argue for the widening of attention in healthcare improvement efforts, to include an awareness of the humanity of people who work in the sector and an appreciation of the part human connection plays in engagement around good quality work. Theoretical frameworks and research approaches which draw on action-based, interpretive and systemic thinking are proposed, as a complement to current practices. Design/methodology/approach The paper describes the early stages of an action research (AR) project, which used the appreciative inquiry "4D" framework to conduct participative inquiry in Hamad Medical Corporation's ambulance service in Qatar, in which staff became co-researchers. Findings The co-researchers were highly motivated to work with improvement goals as a result of their participation in the AR. They, and their managers, saw each other and the work in new ways and discovered that they had much to offer. Research limitations/implications This was a small-scale pilot project, from which findings must be considered tentative. The challenges of establishing good collaboration across language, culture and organisational divides are considerable. Practical implications Appreciative and action-oriented inquiry methods can serve not only to find things out, but also to highlight and give value to aspects of humanity in the workplace that are routinely left invisible in formal processes. This, in turn, can help with quality improvement. Originality/value This paper is a challenge to the orthodox way of viewing healthcare organisations, and improvement processes within them, as reliant on control rather than empowerment. An alternative is to actively include the agency, sense-making capacity and humanity of those involved.

  20. Consumer and community involvement in health and medical research: evaluation by online survey of Australian training workshops for researchers.

    Science.gov (United States)

    McKenzie, Anne; Alpers, Kirsten; Heyworth, Jane; Phuong, Cindy; Hanley, Bec

    2016-01-01

    In Australia, since 2009, the Consumer and Community Involvement Program (formerly the Consumer and Community Participation Program) has developed and run workshops to help people working in health and medical research involve more consumers (patients) and community members (the public) in their research. In 2012, workshop attendees were invited to do an online survey to find out the effect, if any, that attending a workshop had on their awareness of and attitudes to consumer and community involvement. They were also asked about changes in their behaviour when it came to the involvement of consumers and the community in their work. The study found that, for people who answered the survey, more than double the number found consumer and community involvement very relevant after attending a workshop, compared with the number who thought that before attending one. Also, amongst those who answered the survey, 94 % thought that the workshop increased their understanding about involvement. Background There is limited evidence of the benefits of providing training workshops for researchers on how to involve consumers (patients) and the community (public) in health and medical research. Australian training workshops were evaluated to contribute to the evidence base. The key objective was to evaluate the impact of the workshops in increasing awareness of consumer and community involvement; changing attitudes to future implementation of involvement activities and influencing behaviour in the methods of involvement used. A secondary objective was to use a formal evaluation survey to build on the anecdotal feedback received from researchers about changes in awareness, attitudes and behaviours. Methods The study used a cross-sectional, online survey of researchers, students, clinicians, administrators and members of non-government organisations who attended Consumer and Community Involvement Program training workshops between 2009 and 2012 to ascertain changes to awareness

  1. Human Research Program Science Management: Overview of Research and Development Activities

    Science.gov (United States)

    Charles, John B.

    2007-01-01

    An overview of research and development activities of NASA's Human Research Science Management Program is presented. The topics include: 1) Human Research Program Goals; 2) Elements and Projects within HRP; 3) Development and Maintenance of Priorities; 4) Acquisition and Evaluation of Research and Technology Proposals; and 5) Annual Reviews

  2. Embedding a Recovery Orientation into Neuroscience Research: Involving People with a Lived Experience in Research Activity.

    Science.gov (United States)

    Stratford, Anthony; Brophy, Lisa; Castle, David; Harvey, Carol; Robertson, Joanne; Corlett, Philip; Davidson, Larry; Everall, Ian

    2016-03-01

    This paper highlights the importance and value of involving people with a lived experience of mental ill health and recovery in neuroscience research activity. In this era of recovery oriented service delivery, involving people with the lived experience of mental illness in neuroscience research extends beyond their participation as "subjects". The recovery paradigm reconceptualises people with the lived experience of mental ill health as experts by experience. To support this contribution, local policies and procedures, recovery-oriented training for neuroscience researchers, and dialogue about the practical applications of neuroscience research, are required.

  3. 40 CFR 26.1125 - Prior submission of proposed human research for EPA review.

    Science.gov (United States)

    2010-07-01

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

  4. 3 CFR - Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-01-01

    ... 3 The President 1 2010-01-01 2010-01-01 false Guidelines for Human Stem Cell Research Presidential Documents Other Presidential Documents Memorandum of July 30, 2009 Guidelines for Human Stem Cell Research..., scientifically worthy human stem cell research, including human embryonic stem cell research, to the extent...

  5. Involving lay People in Research and Professional Development Through Gaming

    DEFF Research Database (Denmark)

    Magnussen, Rikke

    2017-01-01

    a systematic mapping review methodology, the focus was to map and examine research in these types of games or game environments, and to identify potentials and gaps in the field to inform future research. 89 studies were identified through iterative searching and identification processes applying keywords......Due to the increasing significance of games where lay people are involved in generating knowledge for research or development, the current paper presents a mapping review of status and trends in research of games designed for citizen science, crowdsourcing or community driven research. Using...... they were involved and studies where participants develop knowledge for professional use. The 32 studies were selected for a grounded theory inspired qualitative review and six themes were identified: 1. Motivation; 2. Quality of participant contribution; 3. Learning/education; 4. System/task analysis; 5...

  6. Research on disaster prevention by human factor

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Bok Youn; Kang, Chang Hee; Kang, Sun Duck; Jo, Young Do [Korea Institute of Geology Mining and Materials, Taejon (Korea)

    1998-12-01

    Mining, by its very nature, requires workers and technology to function in an unpredictable environment that can not easily be engineered to accommodate human factors. Miners' physical and cognitive capabilities are sometimes stretched to the point that 'human error' in performance result. Mine safety researchers estimate that 50-85% of all mining injuries are due, in large part, to human error. Further research suggests that the primary causes of these errors in performance lie outside the individual and can be minimized by improvements in equipment design, work environments, work procedures and training. The human factors research is providing the science needed to determine which aspects of the mining environment can be made more worker-friendly and how miners can work more safely in environments that can not be improved. Underground mines have long been recognized as an innately hazardous and physically demanding work environment. Recently, mining is becoming a more complicated process as more sophisticated technologies are introduced. The more complicated or difficult the tasks to be performed, the more critical it is to have a systematic understanding of the humans, the technology, the environments, and how they interact. Human factors is a key component in solving most of today's mine safety and health problems. Human factors research primarily centered around solving problems in the following four areas: 1) How mining methods and equipment affect safety, 2) Evaluating the fit between miner's physical capabilities and the demands of their job, 3) Improving miner's ability to perceive and react to hazards, 4) Understanding how organizational and managerial variables influence safety. Human factor research was begun during the World war II. National Coal Board (British Coal) of Great Britain commenced ergonomics in 1969, and Bureau of Mine of United States started human factor researches in same year. Japan has very short history

  7. Management and research priorities of NASA 'Human Research Program'

    International Nuclear Information System (INIS)

    Zhou Weijun; Diao Tianxi; Li Lijuan; Li Zulan

    2013-01-01

    Research on humans has been the focus of the United States space biomedical research, while 'Human Research Program', as an important project initiated by NASA, aims to reduce the risks to the health and performance of astronauts. This paper analyzed this project in terms of organization and management, funding investment and research directions. (authors)

  8. Human Research Ethics Committees in Technical Universities

    NARCIS (Netherlands)

    Koepsell, D.R.; Brinkman, W.P.; Pont, S.C.

    2014-01-01

    Human research ethics has developed in both theory and practice mostly from experiences in medical research. Human participants, however, are used in a much broader range of research than ethics committees oversee, including both basic and applied research at technical universities. Although

  9. Pediatric oncologists' attitudes towards involving adolescents in decision-making concerning research participation.

    Science.gov (United States)

    de Vries, Martine C; Wit, Jan M; Engberts, Dirk P; Kaspers, Gertjan J L; van Leeuwen, Evert

    2010-07-15

    Various regulations and guidelines stipulate the importance of involving adolescents in decision-making concerning research participation. Several studies have shown that in the context of pediatric oncology this involvement is difficult to achieve due to emotional stress, the complexity of research protocols and limited time. Still, up to 80% of adolescents with cancer enter onto a trial during their illness. The aim of this study was to determine clinicians' views and attitudes towards enrolling adolescents in research, considering the difficulties surrounding their involvement in decision-making. A qualitative multicenter study was performed, using in-depth semi-structured interviews on the informed consent process with 15 pediatric hemato-oncologists. Four central themes emerged that characterize clinicians' attitudes towards involving adolescents in the decision-making process: (1) clinicians regard most adolescents as not capable of participating meaningfully in discussions regarding research; (2) clinicians do not always provide adolescents with all information; (3) proxy consent from parents is obtained and is deemed sufficient; (4) clinician-investigator integrity: clinicians judge research protocols as not being harmful and even in the best interest of the adolescent. Clinicians justify not involving adolescents in research discussions by referring to best interest arguments (adolescents' incompetence, proxy consent, and investigator integrity), although this is not in line with legal regulations and ethical guidelines.

  10. Participatory action research: involving students in parent education.

    Science.gov (United States)

    Fowler, Cathrine; Wu, Cynthia; Lam, Winsome

    2014-01-01

    Competition for scarce clinical placements has increased requiring new and innovative models to be developed to meet the growing need. A participatory action research project was used to provide a community nursing clinical experience of involvement in parent education. Nine Hong Kong nursing students self-selected to participate in the project to implement a parenting program called Parenting Young Children in a Digital World. Three project cycles were used: needs identification, skills development and program implementation. Students were fully involved in each cycle's planning, action and reflection phase. Qualitative and quantitative data were collected to inform the project. The overall outcome of the project was the provision of a rich and viable clinical placement experience that created significant learning opportunities for the students and researchers. This paper will explore the student's participation in this PAR project as an innovative clinical practice opportunity. Copyright © 2013 Elsevier Ltd. All rights reserved.

  11. Can the impact of public involvement on research be evaluated? A mixed methods study

    Science.gov (United States)

    Barber, Rosemary; Boote, Jonathan D; Parry, Glenys D; Cooper, Cindy L; Yeeles, Philippa; Cook, Sarah

    2011-01-01

    Abstract Background  Public involvement is central to health and social research policies, yet few systematic evaluations of its impact have been carried out, raising questions about the feasibility of evaluating the impact of public involvement. Objective  To investigate whether it is feasible to evaluate the impact of public involvement on health and social research. Methods  Mixed methods including a two‐round Delphi study with pre‐specified 80% consensus criterion, with follow‐up interviews. UK and international panellists came from different settings, including universities, health and social care institutions and charitable organizations. They comprised researchers, members of the public, research managers, commissioners and policy makers, self‐selected as having knowledge and/or experience of public involvement in health and/or social research; 124 completed both rounds of the Delphi process. A purposive sample of 14 panellists was interviewed. Results  Consensus was reached that it is feasible to evaluate the impact of public involvement on 5 of 16 impact issues: identifying and prioritizing research topics, disseminating research findings and on key stakeholders. Qualitative analysis revealed the complexities of evaluating a process that is subjective and socially constructed. While many panellists believed that it is morally right to involve the public in research, they also considered that it is appropriate to evaluate the impact of public involvement. Conclusions  This study found consensus among panellists that it is feasible to evaluate the impact of public involvement on some research processes, outcomes and on key stakeholders. The value of public involvement and the importance of evaluating its impact were endorsed. PMID:21324054

  12. Can the impact of public involvement on research be evaluated? A mixed methods study.

    Science.gov (United States)

    Barber, Rosemary; Boote, Jonathan D; Parry, Glenys D; Cooper, Cindy L; Yeeles, Philippa; Cook, Sarah

    2012-09-01

      Public involvement is central to health and social research policies, yet few systematic evaluations of its impact have been carried out, raising questions about the feasibility of evaluating the impact of public involvement.   To investigate whether it is feasible to evaluate the impact of public involvement on health and social research.   Mixed methods including a two-round Delphi study with pre-specified 80% consensus criterion, with follow-up interviews. UK and international panellists came from different settings, including universities, health and social care institutions and charitable organizations. They comprised researchers, members of the public, research managers, commissioners and policy makers, self-selected as having knowledge and/or experience of public involvement in health and/or social research; 124 completed both rounds of the Delphi process. A purposive sample of 14 panellists was interviewed.   Consensus was reached that it is feasible to evaluate the impact of public involvement on 5 of 16 impact issues: identifying and prioritizing research topics, disseminating research findings and on key stakeholders. Qualitative analysis revealed the complexities of evaluating a process that is subjective and socially constructed. While many panellists believed that it is morally right to involve the public in research, they also considered that it is appropriate to evaluate the impact of public involvement.   This study found consensus among panellists that it is feasible to evaluate the impact of public involvement on some research processes, outcomes and on key stakeholders. The value of public involvement and the importance of evaluating its impact were endorsed. © 2011 Blackwell Publishing Ltd.

  13. Involving people with early-stage dementia in qualitative research about their lifeworld perspectives

    DEFF Research Database (Denmark)

    Thoft, Diana Schack

    Involving people with early-stage dementia in qualitative research about their lifeworld perspectives......Involving people with early-stage dementia in qualitative research about their lifeworld perspectives...

  14. Patient involvement in research programming and implementation: a responsive evaluation of the Dialogue Model for research agenda setting

    NARCIS (Netherlands)

    Abma, T.A.; Pittens, C.A.C.M.; Visse, M.; Elberse, J.E.; Broerse, J.E.W.

    2015-01-01

    Background: The Dialogue Model for research agenda-setting, involving multiple stakeholders including patients, was developed and validated in the Netherlands. However, there is little insight into whether and how patient involvement is sustained during the programming and implementation of research

  15. Undergraduate Research Involving Deaf and Hard-of-Hearing Students in Interdisciplinary Science Projects

    Directory of Open Access Journals (Sweden)

    Todd Pagano

    2015-05-01

    Full Text Available Scientific undergraduate research in higher education often yields positive outcomes for student and faculty member participants alike, with underrepresented students often showing even more substantial gains (academic, professional, and personal as a result of the experience. Significant success can be realized when involving deaf and hard-of-hearing (d/hh undergraduate students, who are also vastly underrepresented in the sciences, in interdisciplinary research projects. Even d/hh Associate degree level students and those in the first two years of their postsecondary careers can contribute to, and benefit from, the research process when faculty mentors properly plan/design projects. We discuss strategies, including the dissemination/communication of research results, for involving these students in research groups with different communication dynamics and share both findings of our research program and examples of successful chemical and biological research projects that have involved d/hh undergraduate students. We hope to stimulate a renewed interest in encouraging diversity and involving students with disabilities into higher education research experiences globally and across multiple scientific disciplines, thus strengthening the education and career pipeline of these students.

  16. Human subject research for engineers a practical guide

    CERN Document Server

    de Winter, Joost C F

    2017-01-01

    This Brief introduces engineers to the main principles in ethics, research design, statistics, and publishing of human subject research. In recent years, engineering has become strongly connected to disciplines such as biology, medicine, and psychology. Often, engineers (and engineering students) are expected to perform human subject research. Typical human subject research topics conducted by engineers include human-computer interaction (e.g., evaluating the usability of software), exoskeletons, virtual reality, teleoperation, modelling of human behaviour and decision making (often within the framework of ‘big data’ research), product evaluation, biometrics, behavioural tracking (e.g., of work and travel patterns, or mobile phone use), transport and planning (e.g., an analysis of flows or safety issues), etc. Thus, it can be said that knowledge on how to do human subject research is indispensable for a substantial portion of engineers. Engineers are generally well trained in calculus and mechanics, but m...

  17. Evaluating public involvement in research design and grant development: Using a qualitative document analysis method to analyse an award scheme for researchers.

    Science.gov (United States)

    Baxter, Susan; Muir, Delia; Brereton, Louise; Allmark, Christine; Barber, Rosemary; Harris, Lydia; Hodges, Brian; Khan, Samaira; Baird, Wendy

    2016-01-01

    The National Institute for Health Research (NIHR) Research Design Service (RDS) for Yorkshire and Humber has been running a public involvement funding scheme since 2008. This scheme awards researchers a small amount of money to help them get involvement from patients and/or the public. Involvement activities take place at the time when researchers are planning studies, and when they are completing application forms to request funding for a proposed research project. After the public involvement activities researchers are asked to write a report for the RDS describing what they did with the public involvement funding. This study analysed those reports using an approach which included members of a public involvement panel in the data analysis process. The aim of the work was to see what the views and experiences of researchers who received funding were, and what might be learned for the future of the scheme. Twenty five reports were analysed. Four main themes were identified, these described: the added value of public involvement; aspects to consider when planning and designing public involvement; different roles of public contributors; and aspects of valuing public member contributions. The group approach to analysis was successful in enabling involvement of a variety of individuals in the process. The findings of the study provide evidence of the value of public involvement during the development of applications for research funding. The results also indicate that researchers recognise the variety in potential roles for the public in research, and acknowledge how involvement adds value to studies. Background A regional Research Design Service, funded by the National Institute for Health Research, introduced a small grant in 2008, to support public involvement (often known as patient and public involvement [PPI]) activities during the development of applications for research funding. Successful applicants are requested to submit a report detailing how the grant

  18. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study.

    Science.gov (United States)

    De Smit, Elisabeth; Kearns, Lisa S; Clarke, Linda; Dick, Jonathan; Hill, Catherine L; Hewitt, Alex W

    2016-01-01

    Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs) and Research Governance Offices (RGOs) across Australia. In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA), for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a "National Ethics Application Form" and three a "Low Negligible Risk" form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22) and panel review turnaround time (range nine to 136 days). We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently.

  19. Heterogeneity of Human Research Ethics Committees and Research Governance Offices across Australia: An observational study

    Directory of Open Access Journals (Sweden)

    Elisabeth De Smit

    2016-02-01

    Full Text Available Background Conducting ethically grounded research is a fundamental facet of all investigations. Nevertheless, the administrative burdens of current ethics review are substantial, and calls have been made for a reduction in research waste. Aims To describe the heterogeneity in administration and documentation required by Human Research Ethics Committees (HRECs and Research Governance Offices (RGOs across Australia. Methods In establishing a nationwide study to investigate the molecular aetiology of Giant Cell Arteritis (GCA, for which archived pathological specimens from around Australia are being recruited, we identified variation across separate HREC and RGO requirements. Submission paperwork and correspondence from each collaborating site and its representative office for research were reviewed. This data was interrogated to evaluate differences in current guidelines. Results Twenty-five pathology departments across seven Australian States collaborated in this study. All states, except Victoria, employed a single ethics review model. There was discrepancy amongst HRECs as to which application process applied to our study: seven requested completion of a “National Ethics Application Form” and three a “Low Negligible Risk” form. Noticeable differences in guidelines included whether electronic submission was sufficient. There was variability in the total number of documents submitted (range five to 22 and panel review turnaround time (range nine to 136 days. Conclusion We demonstrate the challenges and illustrate the heavy workload involved in receiving widespread ethics and governance approval across Australia. We highlight the need to simplify, homogenise, and nationalise human ethics for non-clinical trial studies. Reducing unnecessary administration will enable investigators to achieve research aims more efficiently

  20. Genetic testing and its implications: human genetics researchers grapple with ethical issues.

    Science.gov (United States)

    Rabino, Isaac

    2003-01-01

    To better understand ethical issues involved in the field of human genetics and promote debate within the scientific community, the author surveyed scientists who engage in human genetics research about the pros, cons, and ethical implications of genetic testing. This study contributes systematic data on attitudes of scientific experts. The survey finds respondents are highly supportive of voluntary testing and the right to know one's genetic heritage. The majority consider in utero testing and consequent pregnancy termination acceptable for cases involving likelihood of serious disease but disapprove for genetic reasons they consider arbitrary, leaving a gray area of distinguishing between treatment of disorders and enhancement still to be resolved. While safeguarding patient confidentiality versus protecting at-risk third parties (kin, reproductive partners) presents a dilemma, preserving privacy from misuse by institutional third parties (employers, insurers) garners strong consensus for legislation against discrimination. Finally, a call is made for greater genetic literacy.

  1. 75 FR 45130 - Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research...

    Science.gov (United States)

    2010-08-02

    ... and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, rm. 2201, Silver... DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2009-D-0125] Guidance for Industry and Researchers on the Radioactive Drug Research Committee: Human Research Without an...

  2. Human rights, politics, and reviews of research ethics.

    Science.gov (United States)

    Beyrer, Chris; Kass, Nancy E

    2002-07-20

    Although the human rights movement and the sphere of research ethics have overlapping principles and goals, there has been little attempt to incorporate external political and human rights contexts into research ethics codes or ethics reviews. Every element of a research ethics review--the balance of risks and benefits, the assurance of rights for individual participants, and the fair selection of research populations--can be affected by the political and human rights background in which a study is done. Research that at first seems to be low in risk may become high in risk if implemented in a country where the government might breach the confidentiality of study results or where results might be used to deport a refugee group. Researchers should determine whether research could or should be done by consulting human rights organisations and, when possible, a trusted colleague, to learn the background political context and human rights conditions of the settings in which they propose to do research.

  3. Development, implementation and critique of a bioethics framework for pharmaceutical sponsors of human biomedical research.

    Science.gov (United States)

    Van Campen, Luann E; Therasse, Donald G; Klopfenstein, Mitchell; Levine, Robert J

    2015-11-01

    Pharmaceutical human biomedical research is a multi-dimensional endeavor that requires collaboration among many parties, including those who sponsor, conduct, participate in, or stand to benefit from the research. Human subjects' protections have been promulgated to ensure that the benefits of such research are accomplished with respect for and minimal risk to individual research participants, and with an overall sense of fairness. Although these protections are foundational to clinical research, most ethics guidance primarily highlights the responsibilities of investigators and ethics review boards. Currently, there is no published resource that comprehensively addresses bioethical responsibilities of industry sponsors; including their responsibilities to parties who are not research participants, but are, nevertheless key stakeholders in the endeavor. To fill this void, in 2010 Eli Lilly and Company instituted a Bioethics Framework for Human Biomedical Research. This paper describes how the framework was developed and implemented and provides a critique based on four years of experience. A companion article provides the actual document used by Eli Lilly and Company to guide ethical decisions regarding all phases of human clinical trials. While many of the concepts presented in this framework are not novel, compiling them in a manner that articulates the ethical responsibilities of a sponsor is novel. By utilizing this type of bioethics framework, we have been able to develop bioethics positions on various topics, provide research ethics consultations, and integrate bioethics into the daily operations of our human biomedical research. We hope that by sharing these companion papers we will stimulate discussion within and outside the biopharmaceutical industry for the benefit of the multiple parties involved in pharmaceutical human biomedical research.

  4. Mapping frontier research in the humanities

    DEFF Research Database (Denmark)

    -academic fields and supplemented by new transdisciplinary methods focusing on solving grand societal challenges, such as globalisation, multiculturalism, equality, democracy, security and health. Given the nature of these challenges and the ways in which university leadership has been organised, the very notion...... of impact and styles of reasoning, both in classical and interdisciplinary fields of the humanities. From this perspective, a more composite picture of human culture, language and history can emerge from humanities research. It goes beyond the picture of rational agents, and situates human interaction...... in more complex landscapes of collective identities, networks, and constraints that open for new forms of intellectual leadership in the 21st century. Link: http://www.bloomsbury.com/uk/mapping-frontier-research-in-the-humanities-9781472597687/...

  5. Mapping Frontier Research in the Humanities

    DEFF Research Database (Denmark)

    -academic fields and supplemented by new transdisciplinary methods focusing on solving grand societal challenges, such as globalisation, multiculturalism, equality, democracy, security and health. Given the nature of these challenges and the ways in which university leadership has been organised, the very notion...... of impact and styles of reasoning, both in classical and interdisciplinary fields of the humanities. From this perspective, a more composite picture of human culture, language and history can emerge from humanities research. It goes beyond the picture of rational agents, and situates human interaction...... in more complex landscapes of collective identities, networks, and constraints that open for new forms of intellectual leadership in the 21st century. Link: http://www.bloomsbury.com/uk/mapping-frontier-research-in-the-humanities-9781472597687/...

  6. An Evolutionary Genomic Approach to Identify Genes Involved in Human Birth Timing

    Science.gov (United States)

    Orabona, Guilherme; Morgan, Thomas; Haataja, Ritva; Hallman, Mikko; Puttonen, Hilkka; Menon, Ramkumar; Kuczynski, Edward; Norwitz, Errol; Snegovskikh, Victoria; Palotie, Aarno; Fellman, Vineta; DeFranco, Emily A.; Chaudhari, Bimal P.; McGregor, Tracy L.; McElroy, Jude J.; Oetjens, Matthew T.; Teramo, Kari; Borecki, Ingrid; Fay, Justin; Muglia, Louis

    2011-01-01

    Coordination of fetal maturation with birth timing is essential for mammalian reproduction. In humans, preterm birth is a disorder of profound global health significance. The signals initiating parturition in humans have remained elusive, due to divergence in physiological mechanisms between humans and model organisms typically studied. Because of relatively large human head size and narrow birth canal cross-sectional area compared to other primates, we hypothesized that genes involved in parturition would display accelerated evolution along the human and/or higher primate phylogenetic lineages to decrease the length of gestation and promote delivery of a smaller fetus that transits the birth canal more readily. Further, we tested whether current variation in such accelerated genes contributes to preterm birth risk. Evidence from allometric scaling of gestational age suggests human gestation has been shortened relative to other primates. Consistent with our hypothesis, many genes involved in reproduction show human acceleration in their coding or adjacent noncoding regions. We screened >8,400 SNPs in 150 human accelerated genes in 165 Finnish preterm and 163 control mothers for association with preterm birth. In this cohort, the most significant association was in FSHR, and 8 of the 10 most significant SNPs were in this gene. Further evidence for association of a linkage disequilibrium block of SNPs in FSHR, rs11686474, rs11680730, rs12473870, and rs1247381 was found in African Americans. By considering human acceleration, we identified a novel gene that may be associated with preterm birth, FSHR. We anticipate other human accelerated genes will similarly be associated with preterm birth risk and elucidate essential pathways for human parturition. PMID:21533219

  7. The benefits of patient involvement for translational research

    NARCIS (Netherlands)

    van der Scheer, Lieke; Garcia, Elisa; van der Laan, A.L.; van der Burg, Simone; Boenink, Marianne

    The question we raise in this paper is, whether patient involvement might be a beneficial way to help determine and achieve the aims of translational (TR) research and, if so, how to proceed. TR is said to ensure a more effective movement (‘translation’) of basic scientific findings to relevant and

  8. The Benefits of Patient Involvement for Translational Research

    NARCIS (Netherlands)

    Scheer, L. van der; Garcia, E.; Laan, A.L. van der; Burg, S. van der; Boenink, M.

    2017-01-01

    The question we raise in this paper is, whether patient involvement might be a beneficial way to help determine and achieve the aims of translational (TR) research and, if so, how to proceed. TR is said to ensure a more effective movement ('translation') of basic scientific findings to relevant and

  9. Students' Involvement in Faculty Research: Ethical and Methodological Issues

    Directory of Open Access Journals (Sweden)

    Linda M. Ferguson

    2004-12-01

    Full Text Available Faculty who engage students as participants in their qualitative research often encounter methodological and ethical problems. Ethical issues arise from the fiduciary relationship between faculty and their students, and violations of that relationship occur when the educator has a dual role as researcher with those students. Methodological issues arise from research designs to address these ethical issues. This conflict is particularly evident in faculty research on pedagogy in their own disciplines, for which students are necessary as participants but are captive in the relationship. In this article, the authors explore the issues of double agency when faculty involve students as participants in their research.

  10. Research report on human media; Human media no chosa kenkyu hokokusho

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-03-01

    The human multimedia technology corresponding to users` subjective characteristics was researched to realize information environment producing a sense of unity with human. The human media technology realizes a human sensitive information processing model and a common database easily acceptable sensitively by various users. This technology also should be able to fairly accept and transmit individual`s information and knowledge as multimedia information, and in addition it is required to supply a virtual space with presence. In fiscal 1995, the research committee studied the concrete developmental issue for integrating these advanced fundamental technologies, and as practical images planned the prototype systems such as human media interactive plant operation, supply of environment supporting personal intelligent activities, and virtual medical center. The research committee also discussed development of space mobile media to secure energy-saving and safety of automobiles, and an environment simulation system with participation of many people. 34 figs., 2 tabs.

  11. Problematizing Digital Research Evaluation using DOIs in Practice-Based Arts, Humanities and Social Science Research.

    Science.gov (United States)

    Swijghuisen Reigersberg, Muriel

    2015-01-01

    This paper explores emerging practices in research data management in the arts, humanities and social sciences (AHSS). It will do so vis-à-vis current citation conventions and impact measurement for research in AHSS. Case study findings on research data inventoried at Goldsmiths', University of London will be presented. Goldsmiths is a UK research-intensive higher education institution which specialises in arts, humanities and social science research. The paper's aim is to raise awareness of the subject-specific needs of AHSS scholars to help inform the design of future digital tools for impact analysis in AHSS. Firstly, I shall explore the definition of research data and how it is currently understood by AHSS researchers. I will show why many researchers choose not to engage with digital dissemination techniques and ORCID. This discussion must necessarily include the idea that practice-based and applied AHSS research are processes which are not easily captured in numerical 'sets' and cannot be labelled electronically without giving careful consideration to what a group or data item 'represents' as part of the academic enquiry, and therefore how it should be cited and analysed as part of any impact assessment. Then, the paper will explore: the role of the monograph and arts catalogue in AHSS scholarship; how citation practices and digital impact measurement in AHSS currently operate in relation to authorship and how digital identifiers may hypothetically impact on metrics, intellectual property (IP), copyright and research integrity issues in AHSS. I will also show that, if we are to be truly interdisciplinary, as research funders and strategic thinkers say we should, it is necessary to revise the way we think about digital research dissemination. This will involve breaking down the boundaries between AHSS and other types of research.

  12. Research strategies for human performance

    International Nuclear Information System (INIS)

    1998-01-01

    Knowledge about factors that influence Human Performance is essential for the safety of nuclear power plant operation. Through a number of tasks, workshops and projects, experience is shared among OECD countries. At its December 1996 meeting, the CSNI endorsed the SESAR/CAF report on 'Nuclear Safety Research in OECD Countries: Capabilities and Facilities' and requested that the Principal Working Groups (PWGs) review existing co-operative programmes and develop specifications for programmes which address the identified needs. Following discussions between the chairmen of these PWGs and the NEA Secretariat, it was concluded that, for this technical area, the development of programme specifications must be preceded by the development of a strategic document that further elaborates the conclusions of the SESAR/CAF report and set out the general orientation of the research over the medium and long term. Accordingly, a group of senior experts met in August 1997 to discuss possible strategies in the area of Human Performance. The objectives of this meeting were: - To exchange information on existing plans and strategies by different Member countries; - To determine relevant issues and realistic medium/long-term targets and expectations for their resolution, and - To determine, in general sense, possible research programmes, their priority and their likelihood for success. This document is the result of this meeting. Its objective is to present to the CSNI proposals for future work on Human Performance research. The proposals are built upon the work performed to date by PWG1 and PWG5. Carrying out these proposals will continue to require close coordination on joint activities between these two PWGs. Reinforced systematic networking activities are needed particularly in management and organisational performance research to initiate and manage comparison and benchmarking activities. Synchronising the availability of funding is a specific problem in many cases. Since most

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

    Science.gov (United States)

    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.

  14. Undergraduate students' development of social, cultural, and human capital in a networked research experience

    Science.gov (United States)

    Thompson, Jennifer Jo; Conaway, Evan; Dolan, Erin L.

    2016-12-01

    Recent calls for reform in undergraduate biology education have emphasized integrating research experiences into the learning experiences of all undergraduates. Contemporary science research increasingly demands collaboration across disciplines and institutions to investigate complex research questions, providing new contexts and models for involving undergraduates in research. In this study, we examined the experiences of undergraduates participating in a multi-institution and interdisciplinary biology research network. Unlike the traditional apprenticeship model of research, in which a student participates in research under the guidance of a single faculty member, students participating in networked research have the opportunity to develop relationships with additional faculty and students working in other areas of the project, at their own and at other institutions. We examined how students in this network develop social ties and to what extent a networked research experience affords opportunities for students to develop social, cultural, and human capital. Most studies of undergraduate involvement in science research have focused on documenting student outcomes rather than elucidating how students gain access to research experiences or how elements of research participation lead to desired student outcomes. By taking a qualitative approach framed by capital theories, we have identified ways that undergraduates utilize and further develop various forms of capital important for success in science research. In our study of the first 16 months of a biology research network, we found that undergraduates drew upon a combination of human, cultural, and social capital to gain access to the network. Within their immediate research groups, students built multidimensional social ties with faculty, peers, and others, yielding social capital that can be drawn upon for information, resources, and support. They reported developing cultural capital in the form of learning to

  15. Developing a Collaborative Agenda for Humanities and Social Scientific Research on Laboratory Animal Science and Welfare.

    Science.gov (United States)

    Davies, Gail F; Greenhough, Beth J; Hobson-West, Pru; Kirk, Robert G W; Applebee, Ken; Bellingan, Laura C; Berdoy, Manuel; Buller, Henry; Cassaday, Helen J; Davies, Keith; Diefenbacher, Daniela; Druglitrø, Tone; Escobar, Maria Paula; Friese, Carrie; Herrmann, Kathrin; Hinterberger, Amy; Jarrett, Wendy J; Jayne, Kimberley; Johnson, Adam M; Johnson, Elizabeth R; Konold, Timm; Leach, Matthew C; Leonelli, Sabina; Lewis, David I; Lilley, Elliot J; Longridge, Emma R; McLeod, Carmen M; Miele, Mara; Nelson, Nicole C; Ormandy, Elisabeth H; Pallett, Helen; Poort, Lonneke; Pound, Pandora; Ramsden, Edmund; Roe, Emma; Scalway, Helen; Schrader, Astrid; Scotton, Chris J; Scudamore, Cheryl L; Smith, Jane A; Whitfield, Lucy; Wolfensohn, Sarah

    2016-01-01

    Improving laboratory animal science and welfare requires both new scientific research and insights from research in the humanities and social sciences. Whilst scientific research provides evidence to replace, reduce and refine procedures involving laboratory animals (the '3Rs'), work in the humanities and social sciences can help understand the social, economic and cultural processes that enhance or impede humane ways of knowing and working with laboratory animals. However, communication across these disciplinary perspectives is currently limited, and they design research programmes, generate results, engage users, and seek to influence policy in different ways. To facilitate dialogue and future research at this interface, we convened an interdisciplinary group of 45 life scientists, social scientists, humanities scholars, non-governmental organisations and policy-makers to generate a collaborative research agenda. This drew on methods employed by other agenda-setting exercises in science policy, using a collaborative and deliberative approach for the identification of research priorities. Participants were recruited from across the community, invited to submit research questions and vote on their priorities. They then met at an interactive workshop in the UK, discussed all 136 questions submitted, and collectively defined the 30 most important issues for the group. The output is a collaborative future agenda for research in the humanities and social sciences on laboratory animal science and welfare. The questions indicate a demand for new research in the humanities and social sciences to inform emerging discussions and priorities on the governance and practice of laboratory animal research, including on issues around: international harmonisation, openness and public engagement, 'cultures of care', harm-benefit analysis and the future of the 3Rs. The process outlined below underlines the value of interdisciplinary exchange for improving communication across

  16. Developing a Collaborative Agenda for Humanities and Social Scientific Research on Laboratory Animal Science and Welfare

    Science.gov (United States)

    Davies, Gail F.; Greenhough, Beth J; Hobson-West, Pru; Kirk, Robert G. W.; Applebee, Ken; Bellingan, Laura C.; Berdoy, Manuel; Buller, Henry; Cassaday, Helen J.; Davies, Keith; Diefenbacher, Daniela; Druglitrø, Tone; Escobar, Maria Paula; Friese, Carrie; Herrmann, Kathrin; Hinterberger, Amy; Jarrett, Wendy J.; Jayne, Kimberley; Johnson, Adam M.; Johnson, Elizabeth R.; Konold, Timm; Leach, Matthew C.; Leonelli, Sabina; Lewis, David I.; Lilley, Elliot J.; Longridge, Emma R.; McLeod, Carmen M.; Miele, Mara; Nelson, Nicole C.; Ormandy, Elisabeth H.; Pallett, Helen; Poort, Lonneke; Pound, Pandora; Ramsden, Edmund; Roe, Emma; Scalway, Helen; Schrader, Astrid; Scotton, Chris J.; Scudamore, Cheryl L.; Smith, Jane A.; Whitfield, Lucy; Wolfensohn, Sarah

    2016-01-01

    Improving laboratory animal science and welfare requires both new scientific research and insights from research in the humanities and social sciences. Whilst scientific research provides evidence to replace, reduce and refine procedures involving laboratory animals (the ‘3Rs’), work in the humanities and social sciences can help understand the social, economic and cultural processes that enhance or impede humane ways of knowing and working with laboratory animals. However, communication across these disciplinary perspectives is currently limited, and they design research programmes, generate results, engage users, and seek to influence policy in different ways. To facilitate dialogue and future research at this interface, we convened an interdisciplinary group of 45 life scientists, social scientists, humanities scholars, non-governmental organisations and policy-makers to generate a collaborative research agenda. This drew on methods employed by other agenda-setting exercises in science policy, using a collaborative and deliberative approach for the identification of research priorities. Participants were recruited from across the community, invited to submit research questions and vote on their priorities. They then met at an interactive workshop in the UK, discussed all 136 questions submitted, and collectively defined the 30 most important issues for the group. The output is a collaborative future agenda for research in the humanities and social sciences on laboratory animal science and welfare. The questions indicate a demand for new research in the humanities and social sciences to inform emerging discussions and priorities on the governance and practice of laboratory animal research, including on issues around: international harmonisation, openness and public engagement, ‘cultures of care’, harm-benefit analysis and the future of the 3Rs. The process outlined below underlines the value of interdisciplinary exchange for improving communication across

  17. Developing a Collaborative Agenda for Humanities and Social Scientific Research on Laboratory Animal Science and Welfare.

    Directory of Open Access Journals (Sweden)

    Gail F Davies

    Full Text Available Improving laboratory animal science and welfare requires both new scientific research and insights from research in the humanities and social sciences. Whilst scientific research provides evidence to replace, reduce and refine procedures involving laboratory animals (the '3Rs', work in the humanities and social sciences can help understand the social, economic and cultural processes that enhance or impede humane ways of knowing and working with laboratory animals. However, communication across these disciplinary perspectives is currently limited, and they design research programmes, generate results, engage users, and seek to influence policy in different ways. To facilitate dialogue and future research at this interface, we convened an interdisciplinary group of 45 life scientists, social scientists, humanities scholars, non-governmental organisations and policy-makers to generate a collaborative research agenda. This drew on methods employed by other agenda-setting exercises in science policy, using a collaborative and deliberative approach for the identification of research priorities. Participants were recruited from across the community, invited to submit research questions and vote on their priorities. They then met at an interactive workshop in the UK, discussed all 136 questions submitted, and collectively defined the 30 most important issues for the group. The output is a collaborative future agenda for research in the humanities and social sciences on laboratory animal science and welfare. The questions indicate a demand for new research in the humanities and social sciences to inform emerging discussions and priorities on the governance and practice of laboratory animal research, including on issues around: international harmonisation, openness and public engagement, 'cultures of care', harm-benefit analysis and the future of the 3Rs. The process outlined below underlines the value of interdisciplinary exchange for improving

  18. Confirmation of RAX gene involvement in human anophthalmia.

    Science.gov (United States)

    Lequeux, L; Rio, M; Vigouroux, A; Titeux, M; Etchevers, H; Malecaze, F; Chassaing, N; Calvas, P

    2008-10-01

    Microphthalmia and anophthalmia are at the severe end of the spectrum of abnormalities in ocular development. Mutations in several genes have been involved in syndromic and non-syndromic anophthalmia. Previously, RAX recessive mutations were implicated in a single patient with right anophthalmia, left microphthalmia and sclerocornea. In this study, we report the findings of novel compound heterozygous RAX mutations in a child with bilateral anophthalmia. Both mutations are located in exon 3. c.664delT is a frameshifting deletion predicted to introduce a premature stop codon (p.Ser222ArgfsX62), and c.909C>G is a nonsense mutation with similar consequences (p.Tyr303X). This is the second report of a patient with anophthalmia caused by RAX mutations. These findings confirm that RAX plays a major role in the early stages of eye development and is involved in human anophthalmia.

  19. Human factors involvement in bringing the power of AI to a heterogeneous user population

    Science.gov (United States)

    Czerwinski, Mary; Nguyen, Trung

    1994-01-01

    The Human Factors involvement in developing COMPAQ QuickSolve, an electronic problem-solving and information system for Compaq's line of networked printers, is described. Empowering customers with expert system technology so they could solve advanced networked printer problems on their own was a major goal in designing this system. This process would minimize customer down-time, reduce the number of phone calls to the Compaq Customer Support Center, improve customer satisfaction, and, most importantly, differentiate Compaq printers in the marketplace by providing the best, and most technologically advanced, customer support. This represents a re-engineering of Compaq's customer support strategy and implementation. In its first generation system, SMART, the objective was to provide expert knowledge to Compaq's help desk operation to more quickly and correctly answer customer questions and problems. QuickSolve is a second generation system in that customer support is put directly in the hands of the consumers. As a result, the design of QuickSolve presented a number of challenging issues. Because the produce would be used by a diverse and heterogeneous set of users, a significant amount of human factors research and analysis was required while designing and implementing the system. Research that shaped the organization and design of the expert system component as well.

  20. Human Genome Research: Decoding DNA

    Science.gov (United States)

    dropdown arrow Site Map A-Z Index Menu Synopsis Human Genome Research: Decoding DNA Resources with of the DNA double helix during April 2003. James D. Watson, Francis Crick, and Maurice Wilkins were company Celera announced the completion of a "working draft" reference DNA sequence of the human

  1. Report on {open_quotes}inspection of human subject research in intelligence and intelligence-related projects{close_quotes}

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1996-01-16

    Executive Order 12333, {open_quotes}United States Intelligence Activities,{close_quotes} (1) designates the Department`s intelligence element as a member of the Intelligence Community, and (2) states that no agency within the Intelligence community shall sponsor, contract for or conduct research on human subjects except in accordance with guidelines issued by the Department of Health and Human Services. The Federal policy for the Protection of Human Subjects, which was based on Department of Health and Human Services regulations, was promulgated in Title 10 Code of Federal Regulations Part 745 by the Department of Energy. The purpose of this inspection was to review the internal control procedures used by the Office of Nonproliferation and National Security to manage selected intelligence and intelligence-related projects that involve human subject research.

  2. One Health approach to identify research needs in bovine and human babesioses: workshop report

    Directory of Open Access Journals (Sweden)

    McElwain Terry F

    2010-04-01

    Full Text Available Abstract Background Babesia are emerging health threats to humans and animals in the United States. A collaborative effort of multiple disciplines to attain optimal health for people, animals and our environment, otherwise known as the One Health concept, was taken during a research workshop held in April 2009 to identify gaps in scientific knowledge regarding babesioses. The impetus for this analysis was the increased risk for outbreaks of bovine babesiosis, also known as Texas cattle fever, associated with the re-infestation of the U.S. by cattle fever ticks. Results The involvement of wildlife in the ecology of cattle fever ticks jeopardizes the ability of state and federal agencies to keep the national herd free of Texas cattle fever. Similarly, there has been a progressive increase in the number of cases of human babesiosis over the past 25 years due to an increase in the white-tailed deer population. Human babesiosis due to cattle-associated Babesia divergens and Babesia divergens-like organisms have begun to appear in residents of the United States. Research needs for human and bovine babesioses were identified and are presented herein. Conclusions The translation of this research is expected to provide veterinary and public health systems with the tools to mitigate the impact of bovine and human babesioses. However, economic, political, and social commitments are urgently required, including increased national funding for animal and human Babesia research, to prevent the re-establishment of cattle fever ticks and the increasing problem of human babesiosis in the United States.

  3. Possible involvement of loss of imprinting in immortalization of human fibroblasts.

    Science.gov (United States)

    Okamura, Kotaro; Ohno, Maki; Tsutsui, Takeki

    2011-04-01

    Disruption of the normal pattern of parental origin-specific gene expression is referred to as loss of imprinting (LOI), which is common in various cancers. To investigate a possible role of LOI in the early stage of human cell transformation, we studied LOI in 18 human fibroblast cell lines immortalized spontaneously, by viral oncogenes, by chemical or physical carcinogens, or by infection with a retrovirus vector encoding the human telomerase catalytic subunit, hTERT cDNA. LOI was observed in all the 18 immortal cell lines. The gene most commonly exhibiting LOI was NDN which displayed LOI in 15 of the 18 cell lines (83%). The other genes exhibiting LOI at high frequencies were PEG3 (50%), MAGE-L2 (61%) and ZNF 127 (50%). Expression of NDN that was lost in the immortal cell lines was restored by treatment with 5-aza-2'-deoxycytidine. The ratio of histone H3 lysine 9 methylation to histone H3 lysine 4 methylation of the chromatin containing the NDN promoter in the immortal WI-38VA13 cells was greater than that in the parental cells, suggesting chromatin structure-mediated regulation of NDN expression. We previously demonstrated that inactivation of the p16INK4a/pRb pathway is necessary for immortalization of human cells. Human fibroblasts in the pre-crisis phase and cells with an extended lifespan that eventually senesce, both of which have the normal p16INK4a/pRb pathway, did not show LOI at any imprinted gene examined. Although it is not clear if LOI plays a causal role in immortalization of human cells or is merely coincidental, these findings indicate a possible involvement of LOI in immortalization of human cells or a common mechanism involved in both processes.

  4. Sociotechnical Human Factors Involved in Remote Online Usability Testing of Two eHealth Interventions.

    Science.gov (United States)

    Wozney, Lori M; Baxter, Pamela; Fast, Hilary; Cleghorn, Laura; Hundert, Amos S; Newton, Amanda S

    2016-02-03

    Research in the fields of human performance technology and human computer interaction are challenging the traditional macro focus of usability testing arguing for methods that help test moderators assess "use in context" (ie, cognitive skills, usability understood over time) and in authentic "real world" settings. Human factors in these complex test scenarios may impact on the quality of usability results being derived yet there is a lack of research detailing moderator experiences in these test environments. Most comparative research has focused on the impact of the physical environment on results, and rarely on how the sociotechnical elements of the test environment affect moderator and test user performance. Improving our understanding of moderator roles and experiences with conducting "real world" usability testing can lead to improved techniques and strategies To understand moderator experiences of using Web-conferencing software to conduct remote usability testing of 2 eHealth interventions. An exploratory case study approach was used to study 4 moderators' experiences using Blackboard Collaborate for remote testing sessions of 2 different eHealth interventions. Data collection involved audio-recording iterative cycles of test sessions, collecting summary notes taken by moderators, and conducting 2 90-minute focus groups via teleconference. A direct content analysis with an inductive coding approach was used to explore personal accounts, assess the credibility of data interpretation, and generate consensus on the thematic structure of the results. Following the convergence of data from the various sources, 3 major themes were identified: (1) moderators experienced and adapted to unpredictable changes in cognitive load during testing; (2) moderators experienced challenges in creating and sustaining social presence and untangling dialogue; and (3) moderators experienced diverse technical demands, but were able to collaboratively troubleshoot with test users

  5. Lay involvement in the analysis of qualitative data in health services research: a descriptive study.

    Science.gov (United States)

    Garfield, S; Jheeta, S; Husson, F; Jacklin, A; Bischler, A; Norton, C; Franklin, B D

    2016-01-01

    There is a consensus that patients and the public should be involved in research in a meaningful way. However, to date, lay people have been mostly involved in developing research ideas and commenting on patient information.We previously published a paper describing our experience with lay partners conducting observations in a study of how patients in hospital are involved with their medicines. In a later part of the same study, lay partners were also involved in analysing interviews that a researcher had conducted with patients, carers and healthcare professionals about patient and carer involvement with medicines in hospital. We therefore wanted to build on our previous paper and report on our experiences with lay partners helping to conduct data analysis. We therefore interviewed the lay members and researchers involved in the analysis to find out their views.Both lay members and researchers reported that lay partners added value to the study by bringing their own perspectives and identifying further areas for the researcher to look for in the interviews. In this way researchers and lay partners were able to work together to produce a richer analysis than would have been possible from either alone. Background It is recognised that involving lay people in research in a meaningful rather than tokenistic way is both important and challenging. In this paper, we contribute to this debate by describing our experiences of lay involvement in data analysis. Methods We conducted semi-structured interviews with the lay partners and researchers involved in qualitative data analysis in a wider study of inpatient involvement in medication safety. The interviews were transcribed verbatim and coded using open thematic analysis. Results We interviewed three lay partners and the three researchers involved. These interviews demonstrated that the lay members added value to the analysis by bringing their own perspectives; these were systematically integrated into the analysis by the

  6. Challenges of Research and Human Capital Development in Nigeria

    Science.gov (United States)

    Chikwe, Christian K.; Ogidi, Reuben C.; Nwachukwu, K.

    2015-01-01

    The paper discussed the challenges of research and human capital development in Nigeria. Research and human capital development are critical to the development of any nation. Research facilitates human capital development. A high rating in human capital development indices places a country among the leading countries of the world. The paper…

  7. Ethics and research in Human and Social Sciences: a case to be thought

    Directory of Open Access Journals (Sweden)

    Fausto dos Santos Amaral Filho

    2017-01-01

    Full Text Available This paper, fundamentally through the analysis and interpretation of Resolutions that have historically been regulating ethical issues that involve scientific research (CNS Resolutions N. 196/96, N. 466/2012, N. 510/2016, seeks to show the inadequacy of such Resolutions for Human and Social Sciences research. In addition, this text wants to point to the political dispute imposed by the area of biomedical sciences that apparently seems to be little concerned with ethical issues per se and seeks, first and foremost, to maintain its power.

  8. Overview of the Human Exploration Research Analog (HERA)

    Science.gov (United States)

    Neigut, J.

    2015-01-01

    In 2013, the Human Research Program at NASA began developing a new confinement analog specifically for conducting research to investigate the effects of confinement on the human system. The HERA (Human Exploration Research Analog) habitat has been used for both 7 and 14 day missions to date to examine and mitigate exploration risks to enable safe, reliable and productive human space exploration. This presentation will describe how the Flight Analogs Project developed the HERA facility and the infrastructure to suit investigator requirements for confinement research and in the process developed a new approach to analog utilization and a new state of the art analog facility. Details regarding HERA operations will be discussed including specifics on the mission simulation utilized for the current 14-day campaign, the specifics of the facility (total volume, overall size, hardware), and the capabilities available to researchers. The overall operational philosophy, mission fidelity including timeline, schedule pressures and cadence, and development and implementation of mission stressors will be presented. Research conducted to date in the HERA has addressed risks associated with behavioral health and performance, human physiology, as well as human factors. This presentation will conclude with a discussion of future research plans for the HERA, including infrastructure improvements and additional research capabilities planned for the upcoming 30-day missions in 2016.

  9. Pathology as the enabler of human research.

    Science.gov (United States)

    Crawford, James M; Tykocinski, Mark L

    2005-09-01

    Academic Pathology is a key player in human molecular science and in the powerful initiatives of the National Institutes of Health. Pathologists generate data crucial to virtually every molecular study of human tissue, and have the necessary skills and authority to oversee processing of human tissues for research analysis. We advocate that Academic Pathology is optimally positioned to drive the molecular revolution in study of human disease, through human tissue collection, analysis, and databasing. This can be achieved through playing a major role in human tissue procurement and management; establishing high-quality 'Pathology Resource Laboratories'; providing the scientific expertise for pathology data sharing; and recruiting and training physician scientists. Pathology should position itself to be the local institutional driver of technology implementation and development, by operating the resource laboratories, providing the expertise for technical and conceptual design of research projects, maintaining the databases that link molecular and morphological information on human tissues with the requisite clinical databases, providing education and mentorship of technology users, and nurturing new research through the development of preliminary data. We also consider that outstanding pathology journals are available for the publication of research emanating from such studies, to the benefit of the pathology profession as an academic enterprise. It is our earnest hope that Academic Pathology can play a leading role in the remarkable advances to be made as the 21st century unfolds.

  10. Involving users with learning difficulties in health improvement: lessons from inclusive learning disability research.

    Science.gov (United States)

    Walmsley, Jan

    2004-03-01

    In this paper the author considers the lessons to be drawn from what is termed "inclusive" learning disability research for user involvement around health improvement. Inclusive learning disability research refers to research where people with learning difficulties (intellectual disability) are involved as active participants, as opposed to passive subjects. There is by now a considerable body of such research, developed over the past 25 years. From the review, the author draws attention to areas which can inform practice in involvement of users in a way that adds value.

  11. Animal Models and Bone Histomorphometry: Translational Research for the Human Research Program

    Science.gov (United States)

    Sibonga, Jean D.

    2010-01-01

    This slide presentation reviews the use of animal models to research and inform bone morphology, in particular relating to human research in bone loss as a result of low gravity environments. Reasons for use of animal models as tools for human research programs include: time-efficient, cost-effective, invasive measures, and predictability as some model are predictive for drug effects.

  12. Scientific Merit Review of Directed Research Tasks Within the NASA Human Research Program

    Science.gov (United States)

    Charles, John B.

    2010-01-01

    The Human Research Program is instrumental in developing and delivering research findings, health countermeasures, and human systems technologies for spacecraft. :HRP is subdivided into 6 research entities, or Elements. Each Element is charged with providing the Program with knowledge and capabilities to conduct research to address the human health and performance risks as well as advance the readiness levels of technology and countermeasures. Project: An Element may be further subdivided into Projects, which are defined as an integrated set of tasks undertaken to deliver a product or set of products

  13. Paternalism and utilitarianism in research with human participants.

    Science.gov (United States)

    Resnik, David B

    2015-03-01

    In this article I defend a rule utilitarian approach to paternalistic policies in research with human participants. Some rules that restrict individual autonomy can be justified on the grounds that they help to maximize the overall balance of benefits over risks in research. The consequences that should be considered when formulating policy include not only likely impacts on research participants, but also impacts on investigators, institutions, sponsors, and the scientific community. The public reaction to adverse events in research (such as significant injury to participants or death) is a crucial concern that must be taken into account when assessing the consequences of different policy options, because public backlash can lead to outcomes that have a negative impact on science, such as cuts in funding, overly restrictive regulation and oversight, and reduced willingness of individuals to participate in research. I argue that concern about the public reaction to adverse events justifies some restrictions on the risks that competent, adult volunteers can face in research that offers them no significant benefits. The paternalism defended here is not pure, because it involves restrictions on the rights of investigators in order to protect participants. It also has a mixed rationale, because individual autonomy may be restricted not only to protect participants from harm but also to protect other stakeholders. Utility is not the sole justification for paternalistic research policies, since other considerations, such as justice and respect for individual rights/autonomy, must also be taken into account.

  14. Research trends in the South African Journal of Human Resource Management

    Directory of Open Access Journals (Sweden)

    Charlotte Pietersen

    2018-03-01

    Full Text Available Orientation: A comprehensive framework for research in human resource management (HRM in terms of fundamental knowledge orientations was found lacking. Research purpose: The aim was to perform a typological review of research trends in the field of HRM, specifically of publications in the South African Journal of Human Resource Management (SAJHRM. Motivation for the study: No previous research in the field of HRM in South Africa adopted a fundamental theory of knowledge. Research design, approach and method: A qualitative design was followed, consisting of a documentary analysis of articles that were published in the SAJHRM for the period from 2003 to 2015. A detailed content analysis of published articles was performed in terms of a number of criteria, namely knowledge type, race, gender, authorship, author contribution and representation according to author institution and country of origin. Main findings: An analysis of a final selection of 289 articles indicated that research in the SAJHRM was mostly on the following lines: research was mostly of the hypothesis-testing (Type II knowledge type; involved multiple authorship; and was conducted by mostly white, male researchers, based at a relatively few South African academic institutions. Practical and managerial implications: The SAJHRM should, in partnership with the HRM profession, promote and publish research that more prominently addresses the gap between academic HRM and HRM practice, especially in terms of the participatory or action research (Type IV mode of knowledge generation. Contribution: The present analysis of research trends in the SAJHRM provides a broader and more nuanced perspective on forms of research required for the HRM field in South Africa.

  15. Partnering Research Involving Mentoring and Education (PRIME) in Prostate Cancer

    National Research Council Canada - National Science Library

    Price, Marva M

    2007-01-01

    Partnering Research Involving Mentoring and Education in Prostate Cancer (PRIME) is a partnership between two nursing schools, Duke University School of Nursing and North Carolina Central University (NCCU...

  16. Partnering Research Involving Mentoring and Education (PRIME) in Prostate Cancer

    National Research Council Canada - National Science Library

    Price, Marva M

    2006-01-01

    Partnering Research Involving Mentoring and Education in Prostate Cancer (PRIME) is a partnership between two nursing schools, Duke University School of Nursing and North Carolina Central University (NCCU...

  17. Partnering Research Involving Mentoring and Education (PRIME) in Prostate Cancer

    National Research Council Canada - National Science Library

    Price, Marva M

    2008-01-01

    Partnering Research Involving Mentoring and Education in Prostate Cancer (PRIME) was a partnership between two nursing schools, Duke University School of Nursing and North Carolina Central University (NCCU...

  18. The Pluralistic Water Research Concept: A New Human-Water System Research Approach

    Directory of Open Access Journals (Sweden)

    Mariele Evers

    2017-11-01

    Full Text Available The use and management of water systems is influenced by a number of factors, such as economic growth, global change (e.g., urbanization, hydrological-climatic changes, politics, history and culture. Despite noteworthy efforts to develop integrative approaches to analyze water-related problems, human-water research remains a major challenge for scholars and decision makers due to the increasing complexity of human and water systems interactions. Although existing concepts try to integrate the social and water dimensions, they usually have a disciplinary starting point and perspective, which can represent an obstacle to true integration in human-water research. Hence, a pluralistic approach is required to better understand the interactions between human and water systems. This paper discusses prominent human-water concepts (Integrated Water Resources Management (IWRM, socio-hydrology, and political ecology/hydrosocial approach and presents a newly developed concept termed pluralistic water research (PWR. This is not only a pluralistic but also an integrative and interdisciplinary approach which aims to coherently and comprehensively integrate human-water dimensions. The different concepts are illustrated in a synopsis, and diverse framing of research questions are exemplified. The PWR concept integrates physical and social sciences, which enables a comprehensive analysis of human-water interactions and relations. This can lead to a better understanding of water-related issues and potentially sustainable trajectories.

  19. Correction of refractive errors in rhesus macaques (Macaca mulatta) involved in visual research.

    Science.gov (United States)

    Mitchell, Jude F; Boisvert, Chantal J; Reuter, Jon D; Reynolds, John H; Leblanc, Mathias

    2014-08-01

    Macaques are the most common animal model for studies in vision research, and due to their high value as research subjects, often continue to participate in studies well into old age. As is true in humans, visual acuity in macaques is susceptible to refractive errors. Here we report a case study in which an aged macaque demonstrated clear impairment in visual acuity according to performance on a demanding behavioral task. Refraction demonstrated bilateral myopia that significantly affected behavioral and visual tasks. Using corrective lenses, we were able to restore visual acuity. After correction of myopia, the macaque's performance on behavioral tasks was comparable to that of a healthy control. We screened 20 other male macaques to assess the incidence of refractive errors and ocular pathologies in a larger population. Hyperopia was the most frequent ametropia but was mild in all cases. A second macaque had mild myopia and astigmatism in one eye. There were no other pathologies observed on ocular examination. We developed a simple behavioral task that visual research laboratories could use to test visual acuity in macaques. The test was reliable and easily learned by the animals in 1 d. This case study stresses the importance of screening macaques involved in visual science for refractive errors and ocular pathologies to ensure the quality of research; we also provide simple methodology for screening visual acuity in these animals.

  20. Phosphorylation of human INO80 is involved in DNA damage tolerance

    International Nuclear Information System (INIS)

    Kato, Dai; Waki, Mayumi; Umezawa, Masaki; Aoki, Yuka; Utsugi, Takahiko; Ohtsu, Masaya; Murakami, Yasufumi

    2012-01-01

    Highlights: ► Depletion of hINO80 significantly reduced PCNA ubiquitination. ► Depletion of hINO80 significantly reduced nuclear dots intensity of RAD18 after UV irradiation. ► Western blot analyses showed phosphorylated hINO80 C-terminus. ► Overexpression of phosphorylation mutant hINO80 reduced PCNA ubiquitination. -- Abstract: Double strand breaks (DSBs) are the most serious type of DNA damage. DSBs can be generated directly by exposure to ionizing radiation or indirectly by replication fork collapse. The DNA damage tolerance pathway, which is conserved from bacteria to humans, prevents this collapse by overcoming replication blockages. The INO80 chromatin remodeling complex plays an important role in the DNA damage response. The yeast INO80 complex participates in the DNA damage tolerance pathway. The mechanisms regulating yINO80 complex are not fully understood, but yeast INO80 complex are necessary for efficient proliferating cell nuclear antigen (PCNA) ubiquitination and for recruitment of Rad18 to replication forks. In contrast, the function of the mammalian INO80 complex in DNA damage tolerance is less clear. Here, we show that human INO80 was necessary for PCNA ubiquitination and recruitment of Rad18 to DNA damage sites. Moreover, the C-terminal region of human INO80 was phosphorylated, and overexpression of a phosphorylation-deficient mutant of human INO80 resulted in decreased ubiquitination of PCNA during DNA replication. These results suggest that the human INO80 complex, like the yeast complex, was involved in the DNA damage tolerance pathway and that phosphorylation of human INO80 was involved in the DNA damage tolerance pathway. These findings provide new insights into the DNA damage tolerance pathway in mammalian cells.

  1. Alzheimer Europe's position on involving people with dementia in research through PPI (patient and public involvement)

    DEFF Research Database (Denmark)

    Gove, Dianne; Diaz-Ponce, Ana; Georges, Jean

    2018-01-01

    This paper reflects Alzheimer Europe's position on PPI (patient and public involvement) in the context of dementia research and highlights some of the challenges and potential risks and benefits associated with such meaningful involvement. The paper was drafted by Alzheimer Europe in collaboration...... with members of INTERDEM and the European Working Group of People with Dementia. It has been formally adopted by the Board of Alzheimer Europe and endorsed by the Board of INTERDEM and by the JPND working group 'Dementia Outcome Measures - Charting New Territory'. Alzheimer Europe is keen to promote...

  2. The construct of food involvement in behavioral research: scale development and validation.

    Science.gov (United States)

    Bell, Rick; Marshall, David W

    2003-06-01

    The construct of involvement has been found to influence brand loyalty, product information search processing, responses to advertising communications, diffusion of innovations, and ultimately, product choice decisions. Traditionally, involvement has been defined as being a characteristic of either a product or of an individual. In the present research, we make an assumption that an individual's 'food involvement' is a somewhat stable characteristic and we hypothesized that involvement with foods would vary between individuals, that individuals who are more highly involved with food would be better able to discriminate between a set of food samples than would less food involved individuals, and that this discrimination would operate both in affective and perceptive relative judgments. Using standard scale construction techniques, we developed a measure of the characteristic of food involvement, based on activities relating to food acquisition, preparation, cooking, eating and disposal. After several iterations, a final 12-item measure was found to have good test-retest reliability and internal consistency within two subscales. A behavioral validation study demonstrated that measures of food involvement were associated with discrimination and hedonic ratings for a range of foods in a laboratory setting. These findings suggest that food involvement, as measured by the Food Involvement Scale, may be an important mediator to consider when undertaking research with food and food habits.

  3. Computer science security research and human subjects: emerging considerations for research ethics boards.

    Science.gov (United States)

    Buchanan, Elizabeth; Aycock, John; Dexter, Scott; Dittrich, David; Hvizdak, Erin

    2011-06-01

    This paper explores the growing concerns with computer science research, and in particular, computer security research and its relationship with the committees that review human subjects research. It offers cases that review boards are likely to confront, and provides a context for appropriate consideration of such research, as issues of bots, clouds, and worms enter the discourse of human subjects review.

  4. Dimeric ligands for GPCRs involved in human reproduction : synthesis and biological evaluation

    NARCIS (Netherlands)

    Bonger, Kimberly Michelle

    2008-01-01

    Dimeric ligands for G-protein coupled receptors that are involved in human reproduction, namely the gonadotropin releasing hormone receptor, the luteinizing hormone receptor and the follicle-stimulating hormone receptor, were synthesized and biologically evaluated.

  5. Research on Human-Error Factors of Civil Aircraft Pilots Based On Grey Relational Analysis

    Directory of Open Access Journals (Sweden)

    Guo Yundong

    2018-01-01

    Full Text Available In consideration of the situation that civil aviation accidents involve many human-error factors and show the features of typical grey systems, an index system of civil aviation accident human-error factors is built using human factor analysis and classification system model. With the data of accidents happened worldwide between 2008 and 2011, the correlation between human-error factors can be analyzed quantitatively using the method of grey relational analysis. Research results show that the order of main factors affecting pilot human-error factors is preconditions for unsafe acts, unsafe supervision, organization and unsafe acts. The factor related most closely with second-level indexes and pilot human-error factors is the physical/mental limitations of pilots, followed by supervisory violations. The relevancy between the first-level indexes and the corresponding second-level indexes and the relevancy between second-level indexes can also be analyzed quantitatively.

  6. Ontologies and standards in bioscience research: for machine or for human

    Directory of Open Access Journals (Sweden)

    Huaiyu eMi

    2011-02-01

    Full Text Available Ontologies and standards are very important parts of today’s bioscience research. With the rapid increase of biological knowledge, they provide mechanisms to better store and represent data in a controlled and structured way, so that scientists can share the data, and utilize a wide variety of software and tools to manage and analyze the data. Most of these standards are initially designed for computers to access large amounts of data that are difficult for human biologists to handle, and it is important to keep in mind that ultimately biologists are going to produce and interpret the data. While ontologies and standards must follow strict semantic rules that may not be familiar to biologists, effort must be spent to lower the learning barrier by involving biologists in the process of development, and by providing software and tool support. A standard will not succeed without support from the wider bioscience research community. Thus, it is crucial that these standards be designed not only for machines to read, but also to be scientifically accurate and intuitive to human biologists.

  7. Action research methodology in clinical pharmacy: how to involve and change.

    Science.gov (United States)

    Nørgaard, Lotte Stig; Sørensen, Ellen Westh

    2016-06-01

    Introduction The focus in clinical pharmacy practice is and has for the last 30-35 years been on changing the role of pharmacy staff into service orientation and patient counselling. One way of doing this is by involving staff in change process and as a researcher to take part in the change process by establishing partnerships with staff. On the background of the authors' widespread action research (AR)-based experiences, recommendations and comments for how to conduct an AR-study is described, and one of their AR-based studies illustrate the methodology and the research methods used. Methodology AR is defined as an approach to research which is based on a problem-solving relationship between researchers and clients, which aims at both solving a problem and at collaboratively generating new knowledge. Research questions relevant in AR-studies are: what was the working process in this change oriented study? What learning and/or changes took place? What challenges/pitfalls had to be overcome? What were the influence/consequences for the involved parts? When to use If you want to implement new services and want to involve staff and others in the process, an AR methodology is very suitable. The basic advantages of doing AR-based studies are grounded in their participatory and democratic basis and their starting point in problems experienced in practice. Limitations Some of the limitations in AR-studies are that neither of the participants in a project steering group are the only ones to decide. Furthermore, the collective process makes the decision-making procedures relatively complex.

  8. [Clinical research XXIV. From clinical judgment to ethics in research on humans].

    Science.gov (United States)

    Pérez-Rodríguez, Marcela; Palacios-Cruz, Lino; Rivas-Ruiz, Rodolfo; Talavera, Juan O

    2014-01-01

    Bioethics in research is an essential part of the structured review process of an article and it is based on three fundamental principles: respect for persons, beneficence and justice. In addition to not providing valid knowledge, a research with inadequate design, execution and statistical analysis is not ethical either, since these methodological deficiencies will produce information that will not be useful and, therefore, the risks that the participants were exposed to will have been in vain. Beyond scientific validity, there are other aspects that outline if an investigation is ethical, such as the clinical and social value of a study, a fair selection of participants, favorable risk-benefit balance, an independent review, the informed consent and respect for participants and potential participants. Throughout the article here presented, the documents that profile the behavior of investigators to protect the participants, such as the Declaration of Helsinki, the national regulations that rule us and the differences between research without risk, with minimal risk and with greater than minimal risk are discussed. That like in daily life, behavior in research involving human participants must be self-regulated, ie, people with knowledge of the existence of the law discover that the man is outside the realm of nature where work is done under the necessity of natural causality, and falls within the scope of the will; only if the man is free to decide their actions may be a law regulating their action.

  9. Integrating spaceflight human system risk research

    Science.gov (United States)

    Mindock, Jennifer; Lumpkins, Sarah; Anton, Wilma; Havenhill, Maria; Shelhamer, Mark; Canga, Michael

    2017-10-01

    NASA is working to increase the likelihood of exploration mission success and to maintain crew health, both during exploration missions and long term after return to Earth. To manage the risks in achieving these goals, a system modelled after a Continuous Risk Management framework is in place. ;Human System Risks; (Risks) have been identified, and 32 are currently being actively addressed by NASA's Human Research Program (HRP). Research plans for each of HRP's Risks have been developed and are being executed. Inter-disciplinary ties between the research efforts supporting each Risk have been identified; however, efforts to identify and benefit from these connections have been mostly ad hoc. There is growing recognition that solutions developed to address the full set of Risks covering medical, physiological, behavioural, vehicle, and organizational aspects of exploration missions must be integrated across Risks and disciplines. This paper discusses how a framework of factors influencing human health and performance in space is being applied as the backbone for bringing together sometimes disparate information relevant to the individual Risks. The resulting interrelated information enables identification and visualization of connections between Risks and research efforts in a systematic and standardized manner. This paper also discusses the applications of the visualizations and insights into research planning, solicitation, and decision-making processes.

  10. Human memory research: Current hypotheses and new perspectives

    Directory of Open Access Journals (Sweden)

    Antônio Jaeger

    Full Text Available Abstract Research on human memory has increased significantly in the last few decades. Inconsistencies and controversies inherent to such research, however, are rarely articulated on published reports. The goal of the present article is to present and discuss a series of open questions related to major topics on human memory research that can be addressed by future research. The topics covered here are visual working memory, recognition memory, emotion and memory interaction, and methodological issues of false memories studies. Overall, the present work reveals a series of open questions and alternative analysis which could be useful for the process of hypothesis generation, and consequently for the design and implementation of future research on human memory.

  11. The contribution of human/non-human animal chimeras to stem cell research

    Directory of Open Access Journals (Sweden)

    Sonya Levine

    2017-10-01

    Full Text Available Chimeric animals are made up of cells from two separate zygotes. Human/non-human animal chimeras have been used for a number of research purposes, including human disease modeling. Pluripotent stem cell (PSC research has relied upon the chimera approach to examine the developmental potential of stem cells, to determine the efficacy of cell replacement therapies, and to establish a means of producing human organs. Based on ethical issues, this work has faced pushback from various sources including funding agencies. We discuss here the essential role these studies have played, from gaining a better understanding of human biology to providing a stepping stone to human disease treatments. We also consider the major ethical issues, as well as the current status of support for this work in the United States.

  12. Human Factors Regulatory Research Program Plan, FY 1989--FY 1992

    International Nuclear Information System (INIS)

    Coffman, F.; Persensky, J.; Ryan, T.; Ramey-Smith, A.; Goodman, C.; Serig, D.; Trager, E; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC; Nuclear Regulatory Commission, Washington, DC

    1989-10-01

    This report describes the currently ongoing (FY 1989) and planned (FY 1989-1992) Human Factors Regulatory Research Program in the NRC Office of Nuclear Regulatory Research (RES). Examples of the influence of human factors on nuclear safety are presented, and the role of personnel is discussed. Current regulatory issues associated with human factors in the nuclear system and the purpose of the research plan are provided. The report describes the research process applied to the human factors research issues and the program activities: Personnel Performance Measurement, Personnel Subsystem, Human-System Interface. Organization and Management, and Reliability Assessment. The research being conducted within each activity is summarized along with the objectives, background information, and expected regulatory products. Budget and personnel forecasts are provided along with a summary of contractors performing some of the ongoing research. Appendices contain a chronology of human factors research at NRC, a description of the research approach, an update on human factors programs and initiatives in RES and other NRC offices, and the integration among these programs. 46 refs., 5 tabs

  13. Overview of NRC's human factors regulatory research program

    International Nuclear Information System (INIS)

    Coffman, F.D. Jr.

    1989-01-01

    The human factors research program is divided into distinct and interrelated program activities: (1) Personnel Performance measurement, (2) Personnel Subsystem, (3) Human-System Interface, (4) Organization and Management, and (5) a group of Reliability Assessment activities. The purpose of the Personnel Performance Measurement activity is to improve the Agency's understanding of the factors influencing personnel performance and the effects on the safety of nuclear operations and maintenance by developing improvements to methods for collecting and managing personnel performance data. Personnel Subsystem research will broaden the understanding of such factors as staffing, qualifications, and training that influence human performance in the nuclear system and will develop the technical basis for regulatory guidance to reduce any adverse impact of these influences on nuclear safety. Research in the Human-System Interface activity will provide the technical basis for ensuring that the interface between the system and the human user supports safe operations and maintenance. Organization and Management research will result in the development of tools for evaluating organization and management issues within the nuclear industry. And finally, the Reliability Assessment group of activities includes multidisciplinary research that will integrate human and hardware considerations for evaluating reliability and risk in NRC licensing, inspection, and regulatory decisions

  14. Involving Latina/o parents in patient-centered outcomes research: Contributions to research study design, implementation and outcomes.

    Science.gov (United States)

    Pérez Jolles, Mónica; Martinez, Maria; Garcia, San Juanita; Stein, Gabriela L; Thomas, Kathleen C

    2017-10-01

    Comparative effectiveness research (CER) is supported by policymakers as a way to provide service providers and patients with evidence-based information to make better health-care decisions and ultimately improve services for patients. However, Latina/o patients are rarely involved as study advisors, and there is a lack of documentation on how their voices contribute to the research process when they are included as collaborators. The purpose of this article was to contribute to the literature by presenting concrete contributions of Latina/o parent involvement to study design, implementation and outcomes in the context of a CER study called Padres Efectivos (Parent Activation). Researchers facilitated a collaborative relationship with parents by establishing a mentor parent group. The contributions of parent involvement in the following stages of the research process are described: (i) proposal development, (ii) implementation of protocols, (iii) analysis plan and (iv) dissemination of results. Mentor parents' contributions helped tailor the content of the intervention to their needs during proposal, increased recruitment, validated the main outcome measure and added two important outcome measures, emphasized the importance of controlling for novice treatment status and developed innovative dissemination strategies. Mentor parents' guidance to the researchers has contributed to reaching recruitment goals, strengthened the study protocol, expanded findings, supported broad ownership of study implications and enriched the overall study data collection efforts. These findings can inform future research efforts seeking an active Latino parent collaboration and the timely incorporation of parent voices in each phase of the research process. © 2017 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  15. Children's Decision-Making Involvement About Research Participation: Associations With Perceived Fairness and Self-Efficacy.

    Science.gov (United States)

    Miller, Victoria A; Feudtner, Chris; Jawad, Abbas F

    2017-04-01

    The primary objective of this study was to examine the associations of children's involvement in decisions about research participation with their perceptions of the decision-making process and self-efficacy. Participants were children (ages 8-17) who enrolled in research studies in the prior 2 months. Children completed a questionnaire that yielded three decision-making involvement subscales: Researcher Engages Child, Researcher Supports Autonomy, and Child Participates. Children reported on fairness of the decision-making process and health-related decision self-efficacy. After adjusting for age, higher scores on Researcher Engages Child were associated with greater self-efficacy, and higher scores on Researcher Supports Autonomy were associated with greater perceived fairness. These data underscore the potential importance of researcher-child interactions about research participation when assent is sought, including proactively involving children in the decision by asking for their opinions and communicating their central role in the decision, which are likely to be more meaningful to children than receiving information or signing a form.

  16. Resident Research Fundamentals Course Human Research Curves in the Road

    Science.gov (United States)

    2017-09-27

    MDW/SGVU SUBJECT: Professional Presentation Approval 27 JULY 2017 Your paper, entitled Resident Research Fundamentals Course - "Human Research ...Curves in the Road" (27 Sep 2017) presented at/published to Resident Research Fundamentals Course - JBSA Lackland, San Antonio, TX - 27 Sep 2017 in...are a Graduate Health Sciences Education student and your department has told you they cannot fund your publication, the 59th Clinical Research

  17. Research trend on human error reduction

    International Nuclear Information System (INIS)

    Miyaoka, Sadaoki

    1990-01-01

    Human error has been the problem in all industries. In 1988, the Bureau of Mines, Department of the Interior, USA, carried out the worldwide survey on the human error in all industries in relation to the fatal accidents in mines. There was difference in the results according to the methods of collecting data, but the proportion that human error took in the total accidents distributed in the wide range of 20∼85%, and was 35% on the average. The rate of occurrence of accidents and troubles in Japanese nuclear power stations is shown, and the rate of occurrence of human error is 0∼0.5 cases/reactor-year, which did not much vary. Therefore, the proportion that human error took in the total tended to increase, and it has become important to reduce human error for lowering the rate of occurrence of accidents and troubles hereafter. After the TMI accident in 1979 in USA, the research on man-machine interface became active, and after the Chernobyl accident in 1986 in USSR, the problem of organization and management has been studied. In Japan, 'Safety 21' was drawn up by the Advisory Committee for Energy, and also the annual reports on nuclear safety pointed out the importance of human factors. The state of the research on human factors in Japan and abroad and three targets to reduce human error are reported. (K.I.)

  18. Different differences: The use of ‘genetic ancestry’ versus race in biomedical human genetic research

    Science.gov (United States)

    Fujimura, Joan H.; Rajagopalan, Ramya

    2011-01-01

    This article presents findings from our ethnographic research on biomedical scientists’ studies of human genetic variation and common complex disease. We examine the socio-material work involved in genome-wide association studies (GWAS) and discuss whether, how, and when notions of race and ethnicity are or are not used. We analyze how researchers produce simultaneously different kinds of populations and population differences. Although many geneticists use race in their analyses, we find some who have invented a statistical genetics method and associated software that they use specifically to avoid using categories of race in their genetics analysis. Their method allows them to operationalize their concept of ‘genetic ancestry’ without resorting to notions of race and ethnicity. We focus on the construction and implementation of the software’s algorithms, and discuss the consequences and implications of the software technology for debates and policies around the use of race in genetics research. We also demonstrate that the production and use of their method involves a dynamic and fluid assemblage of actors in various disciplines responding to disciplinary and sociopolitical contexts and concerns. This assemblage also includes particular discourses on human history and geography as they become entangled with research on genetic markers and disease. We introduce the concept of ‘genome geography’, to analyze how some researchers studying human genetic variation ‘locate’ stretches of DNA in different places and times. The concept of genetic ancestry and the practice of genome geography rely on old discourses, but they also incorporate new technologies, infrastructures, and political and scientific commitments. Some of these new technologies provide opportunities to change some of our institutional and cultural forms and frames around notions of difference and similarity. Neverthless, we also highlight the slipperiness of genome geography and the

  19. Partners in projects: preparing for public involvement in health and social care research.

    Science.gov (United States)

    Parkes, Jacqueline H; Pyer, Michelle; Wray, Paula; Taylor, Jane

    2014-09-01

    In recent years, several UK and, international funders of health and social care related research have adopted the policy of requiring explicit evidence of the 'public' voice in all aspects of project design. For many academic researchers engaged within research, evaluations or audit projects, this formal requirement to actively engage members of the public will present them with both benefits and challenges to securing knowledgeable, skilled, and confident lay representation onto project teams. This could potentially lead to the exploitation of those individuals who are available, appropriately informed, and adequately prepared for such activities. Currently, much of the preparation of patients or members of the public for research involvement tends to be aligned to specific projects; however, with the call for greater active and meaningful involvement of lay representatives in future national and international funding applications, there is clearly a growing need to 'train' sufficient numbers of confident and competent representatives to meet this growing demand. This paper describes the development of a specifically designed research awareness training programme and underpinning theoretical model, which has been specifically designed to support active and meaningful lay involvement in research, evaluations and audit projects. Developed over a four year period, the course is a culmination of learning extracted from a series of four completed research projects, which have incorporated an element of public and patient involvement (PPI) training in their overall design. Crown Copyright © 2014. Published by Elsevier Ireland Ltd. All rights reserved.

  20. Human-Robot Interaction Directed Research Project

    Science.gov (United States)

    Rochlis, Jennifer; Ezer, Neta; Sandor, Aniko

    2011-01-01

    Human-robot interaction (HRI) is about understanding and shaping the interactions between humans and robots (Goodrich & Schultz, 2007). It is important to evaluate how the design of interfaces and command modalities affect the human s ability to perform tasks accurately, efficiently, and effectively (Crandall, Goodrich, Olsen Jr., & Nielsen, 2005) It is also critical to evaluate the effects of human-robot interfaces and command modalities on operator mental workload (Sheridan, 1992) and situation awareness (Endsley, Bolt , & Jones, 2003). By understanding the effects of interface design on human performance, workload, and situation awareness, interfaces can be developed that support the human in performing tasks with minimal errors and with appropriate interaction time and effort. Thus, the results of research on human-robot interfaces have direct implications for design. Because the factors associated with interfaces and command modalities in HRI are too numerous to address in 3 years of research, the proposed research concentrates on three manageable areas applicable to National Aeronautics and Space Administration (NASA) robot systems. These topic areas emerged from the Fiscal Year (FY) 2011 work that included extensive literature reviews and observations of NASA systems. The three topic areas are: 1) video overlays, 2) camera views, and 3) command modalities. Each area is described in detail below, along with relevance to existing NASA human-robot systems. In addition to studies in these three topic areas, a workshop is proposed for FY12. The workshop will bring together experts in human-robot interaction and robotics to discuss the state of the practice as applicable to research in space robotics. Studies proposed in the area of video overlays consider two factors in the implementation of augmented reality (AR) for operator displays during teleoperation. The first of these factors is the type of navigational guidance provided by AR symbology. In the proposed

  1. Pediatric oncologists' attitudes towards involving adolescents in decision-making concerning research participation.

    NARCIS (Netherlands)

    Vries, M.C. de; Wit, J.M.; Engberts, D.P.; Kaspers, G.J.L.; Leeuwen, E. van

    2010-01-01

    BACKGROUND: Various regulations and guidelines stipulate the importance of involving adolescents in decision-making concerning research participation. Several studies have shown that in the context of pediatric oncology this involvement is difficult to achieve due to emotional stress, the complexity

  2. The power of symbolic capital in patient and public involvement in health research.

    Science.gov (United States)

    Locock, Louise; Boylan, Anne-Marie; Snow, Rosamund; Staniszewska, Sophie

    2017-10-01

    Policy-makers and health research funders increasingly require researchers to demonstrate that they have involved patients in the design and conduct of research. However, the extent to which patients and public have the power to get involved on an equal footing is dependent on their economic, cultural, social and symbolic capital. To explore power relations in patient and public involvement (PPI) in research, particularly how patients may wield symbolic capital to develop a more equal relationship. Narrative interviews with a maximum variation sample of 38 people involved as patients, carers or public in health research, analysed thematically. Symbolic capital may be demonstrated in a range of ways (sometimes alongside or in the absence of other forms of capital): illness experience, technical illness knowledge and the challenging outsider. Symbolic capital is unstable and dependent on others for recognition and legitimacy. Nonetheless, participants identify a gradual shift in power relations over time. Research into PPI has been conceptually and theoretically poor, limiting our understanding of its mechanisms and wider contextual elements. Our findings demonstrate the importance of reflecting on the forms of power and capital wielded by the health research community, and of acknowledging the way in which PPI is challenging the status quo. As one of the first papers to conceptualize how different forms of symbolic capital operate and their critical role in challenging the balance of power, our findings may help researchers better plan their PPI activities and reflect on their own power. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

  3. Contingency learning in human fear conditioning involves the ventral striatum.

    Science.gov (United States)

    Klucken, Tim; Tabbert, Katharina; Schweckendiek, Jan; Merz, Christian Josef; Kagerer, Sabine; Vaitl, Dieter; Stark, Rudolf

    2009-11-01

    The ability to detect and learn contingencies between fearful stimuli and their predictive cues is an important capacity to cope with the environment. Contingency awareness refers to the ability to verbalize the relationships between conditioned and unconditioned stimuli. Although there is a heated debate about the influence of contingency awareness on conditioned fear responses, neural correlates behind the formation process of contingency awareness have gained only little attention in human fear conditioning. Recent animal studies indicate that the ventral striatum (VS) could be involved in this process, but in human studies the VS is mostly associated with positive emotions. To examine this question, we reanalyzed four recently published classical fear conditioning studies (n = 117) with respect to the VS at three distinct levels of contingency awareness: subjects, who did not learn the contingencies (unaware), subjects, who learned the contingencies during the experiment (learned aware) and subjects, who were informed about the contingencies in advance (instructed aware). The results showed significantly increased activations in the left and right VS in learned aware compared to unaware subjects. Interestingly, this activation pattern was only found in learned but not in instructed aware subjects. We assume that the VS is not involved when contingency awareness does not develop during conditioning or when contingency awareness is unambiguously induced already prior to conditioning. VS involvement seems to be important for the transition from a contingency unaware to a contingency aware state. Implications for fear conditioning models as well as for the contingency awareness debate are discussed.

  4. An Observational Study of Children's Involvement in Informed Consent for Exome Sequencing Research.

    Science.gov (United States)

    Miller, Victoria A; Werner-Lin, Allison; Walser, Sarah A; Biswas, Sawona; Bernhardt, Barbara A

    2017-02-01

    The goal of this study was to examine children's involvement in consent sessions for exome sequencing research and associations of involvement with provider and parent communication. Participants included 44 children (8-17 years) from five cohorts who were offered participation in an exome sequencing study. The consent sessions were audiotaped, transcribed, and coded. Providers attempted to facilitate the child's involvement in the majority (73%) of sessions, and most (75%) children also verbally participated. Provider facilitation was strongly associated with likelihood of child participation. These findings underscore that strategies such as asking for children's opinions and soliciting their questions show respect for children and may increase the likelihood that they are engaged and involved in decisions about research participation.

  5. The contribution of human/non-human animal chimeras to stem cell research.

    Science.gov (United States)

    Levine, Sonya; Grabel, Laura

    2017-10-01

    Chimeric animals are made up of cells from two separate zygotes. Human/non-human animal chimeras have been used for a number of research purposes, including human disease modeling. Pluripotent stem cell (PSC) research has relied upon the chimera approach to examine the developmental potential of stem cells, to determine the efficacy of cell replacement therapies, and to establish a means of producing human organs. Based on ethical issues, this work has faced pushback from various sources including funding agencies. We discuss here the essential role these studies have played, from gaining a better understanding of human biology to providing a stepping stone to human disease treatments. We also consider the major ethical issues, as well as the current status of support for this work in the United States. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  6. A Research Framework for Understanding the Practical Impact of Family Involvement in the Juvenile Justice System: The Juvenile Justice Family Involvement Model.

    Science.gov (United States)

    Walker, Sarah Cusworth; Bishop, Asia S; Pullmann, Michael D; Bauer, Grace

    2015-12-01

    Family involvement is recognized as a critical element of service planning for children's mental health, welfare and education. For the juvenile justice system, however, parents' roles in this system are complex due to youths' legal rights, public safety, a process which can legally position parents as plaintiffs, and a historical legacy of blaming parents for youth indiscretions. Three recent national surveys of juvenile justice-involved parents reveal that the current paradigm elicits feelings of stress, shame and distrust among parents and is likely leading to worse outcomes for youth, families and communities. While research on the impact of family involvement in the justice system is starting to emerge, the field currently has no organizing framework to guide a research agenda, interpret outcomes or translate findings for practitioners. We propose a research framework for family involvement that is informed by a comprehensive review and content analysis of current, published arguments for family involvement in juvenile justice along with a synthesis of family involvement efforts in other child-serving systems. In this model, family involvement is presented as an ascending, ordinal concept beginning with (1) exclusion, and moving toward climates characterized by (2) information-giving, (3) information-eliciting and (4) full, decision-making partnerships. Specific examples of how courts and facilities might align with these levels are described. Further, the model makes predictions for how involvement will impact outcomes at multiple levels with applications for other child-serving systems.

  7. Framing the Undergraduate Research Experience: Discovery Involvement in Retailing Undergraduate Education

    Science.gov (United States)

    Sternquist, Brenda; Huddleston, Patricia; Fairhurst, Ann

    2018-01-01

    We provide an overview of ways to involve undergraduate business and retailing students in faculty research projects and discuss advantages of these student-faculty collaborations. We use Kolb's experiential learning cycle to provide a framework for creating an effective and engaging undergraduate research experience and use it to classify types…

  8. Status of human factors research program in Central Research Institute of Electric Power Industry

    International Nuclear Information System (INIS)

    Kabetani, Tetsuji

    1989-01-01

    The Human Factors Research Center was established within CRIEPI on July 1, 1987 as its research efforts to reduce human error during operation and maintenance at Japanese nuclear power plants. The Research Program has seven subjects, composed of the original subjects that include the human behavior monitoring method, and the subjects requested by the Federation of Electric Power Companies that include the establishment of techniques of analysing and evaluating information on human error. Some results of the activity are applied in nuclear power plants. We plan to obtain good results to apply to plants, and to improve the results already obtained. (author)

  9. The research trends of Arts, Humanities and Social Sciences ...

    African Journals Online (AJOL)

    A bibliometric method was used to analyse the trends and challenges of Humanities and Social Sciences research by using research data reflecting on ongoing and completed Arts, Humanities and Social Science research publications submitted by staff and students from 1994 – 2008 to the university's Research Office.

  10. Human genome and genetic sequencing research and informed consent

    International Nuclear Information System (INIS)

    Iwakawa, Mayumi

    2003-01-01

    On March 29, 2001, the Ethical Guidelines for Human Genome and Genetic Sequencing Research were established. They have intended to serve as ethical guidelines for all human genome and genetic sequencing research practice, for the purpose of upholding respect for human dignity and rights and enforcing use of proper methods in the pursuit of human genome and genetic sequencing research, with the understanding and cooperation of the public. The RadGenomics Project has prepared a research protocol and informed consent document that follow these ethical guidelines. We have endeavored to protect the privacy of individual information, and have established a procedure for examination of research practices by an ethics committee. Here we report our procedure in order to offer this concept to the patients. (authors)

  11. ORGANIC RESEARCH AND STAKEHOLDERS INVOLVEMENT: THE IFOAM EU REGIONAL GROUP CONTRIBUTION

    OpenAIRE

    Gonzalvez, Mr V; Schlueter, Mr M; Slabe, Ms A; Schmid, Mr O

    2006-01-01

    The paper presents the concepts, criteria, procedures and some methodologies to increase stakeholders involvement and participatioin in organic research Projects in the European Union, based on the experiencie and practise of the IFOAM EU Regional Group (IFOAM-EURG), in transnational Organic research Projects, enfatising in achivements, dificulties and trends for the future

  12. National Human Genome Research Institute

    Science.gov (United States)

    ... Care Genomic Medicine Working Group New Horizons and Research Patient Management Policy and Ethics Issues Quick Links for Patient Care Education All About the Human Genome Project Fact Sheets Genetic Education Resources for ...

  13. Indicators for Research Performance in the Humanities? The Scholars’ View on Research Quality and Indicators

    Energy Technology Data Exchange (ETDEWEB)

    Ochsner, M.; Hug, S.E.

    2016-07-01

    In this paper, we present indicators for research quality in the humanities collected in our previous work (Ochsner, Hug, & Daniel, 2012). We focus on how these indicators are accepted by humanities scholars. We also investigate differences between different subgroups of the humanities scholars we surveyed with regard to their preferences for such indicators. We address the theme of the conference (‘peripheries frontiers and beyond’) regarding two notions of (scientometric) periphery: First, we investigate indicators for research quality in the humanities, a field where there is a lack on knowledge on how to assess or even measure research quality, in fact, there is a quite broad consensus that (evaluative) bibliometrics cannot be readily applied in the humanities (Hicks, 2004; Nederhof, 2006). Second, we fully cover three humanities disciplines at Swiss universities and member universities of the League of European Research Universities (LERU). Scholars are a neglected stakeholder when it comes to the design of research assessment procedures or the selection of research indicators. However, they are directly affected, they know best what research quality in their field is and what impact the use of certain indicators could have on their research practices. The paper is structured as follows: first, we present the background for selecting indicators for research quality. This is followed by a description of our analysis methods and the presentation of the results. We finally discuss the results with regard to their use in research evaluation. (Author)

  14. Unintended consequences of human research ethics committees: au revoir workplace studies?

    Science.gov (United States)

    Bamber, Greg J; Sappey, Jennifer

    2007-07-01

    To protect the welfare and rights of participants in research and to facilitate research that will be of benefit, as well as protect them against litigation, universities and research-funding agencies in Australia adopted the National Statement on Ethical Conduct in Research Involving Humans (NHMRC 1999). In many other countries there are similar statements. However, the ways in which such statements are often implemented by Human Research Ethics Committees (HRECs) are in conflict with an important stream of industrial sociological research. This stream seeks to deconstruct workplaces and de-layer management rhetoric to understand the realities and complexities of the social relations of production. There is a pluralist basis for much industrial sociology that challenges the unitarist view of the workplace as essentially harmonious. While views of workplaces as being conflictual and exploitative have to be tempered with an understanding of the accommodative and cooperative nature of workplace relations, there is nevertheless a general recognition of acts of resistance, as well as those of cooperation. The way in which the National Statement is typically implemented in Australia means that many HRECs require written, informed consent, which in the first instance will usually be that of management. An unintended consequence is a research focus on consensus, which is at best one-sided and at worst seriously misleading. It is unlikely that managerial consent will be granted unless there is a 'good news story' guaranteed. This article explores the ways in which HRECs may influence workplace research. The publication of the revised National Statement provides a valuable opportunity not to be missed by HRECs to implement more effective and efficient practices which would not have the unintended consequences of the earlier version. This would deserve the support of researchers in industrial sociology and other branches of the social sciences.

  15. Patient and public involvement in primary care research - an example of ensuring its sustainability.

    Science.gov (United States)

    Jinks, Clare; Carter, Pam; Rhodes, Carol; Taylor, Robert; Beech, Roger; Dziedzic, Krysia; Blackburn, Steven; Hughes, Rhian; Ong, Bie Nio

    2016-01-01

    The international literature on patient and public involvement (PPI) in research covers a wide range of issues, including active lay involvement throughout the research cycle; roles that patients/public can play; assessing impact of PPI and recommendations for good PPI practice. One area of investigation that is less developed is the sustainability and impact of PPI beyond involvement in time-limited research projects. This paper focuses on the issues of sustainability, the importance of institutional leadership and the creation of a robust infrastructure in order to achieve long-term and wide-ranging PPI in research strategy and programmes. We use the case of a Primary Care Research Centre to provide a historical account of the evolution of PPI in the Centre and identified a number of key conceptual issues regarding infrastructure, resource allocation, working methods, roles and relationships. The paper concludes about the more general applicability of the Centre's model for the long-term sustainability of PPI in research.

  16. Co-ordinated research programme on applications of stable isotope tracers in human nutrition research

    International Nuclear Information System (INIS)

    1989-01-01

    This Co-ordinated Research Programme (CRP) was formally established by the Agency in October 1988, and has since then expanded to encompass 13 participants in 13 countries. Its general objective is to help establish competence in the use of stable isotope techniques, particularly in developing countries, and particularly with reference to applications of 2 H, 13 C, 15 N, and 18 O. This report summarizes the discussions that took place during the first Research Co-ordination Meeting (RCM). Working papers (progress reports) presented by the participants are included as annexes together with a preliminary report on the results of a series of intercomparison exercises involving enriched stable isotope reference materials containing 2 H, 13 C, 15 N and 18 O. For the future it was agreed that more work needs to be done to harmonize the analytical techniques being used, and to obtain support for new CRPs relating to human energy expenditure studies in pregnancy, lactation, growth and other conditions, and to studies of nitrogen turnover in relation to malnutrition and liver function. Refs, figs and tabs

  17. The ethics of cloning and human embryo research.

    Science.gov (United States)

    Saran, Madeleine

    2002-01-01

    The successful cloning experiments that led to Dolly in 1997 have raised many ethical and policy questions. This paper will focus on cloning research in human embryonic cells. The possible gains of the research will be judged against the moral issues of doing research on a person. This paper concludes that while the embryo has some moral status, its moral status is outweighed by the multitude of benefits that embryonic stem cell research will bring to humanity. Policy suggestions are given for dealing with this new and developing field of stem cell research.

  18. Research strategies for human performance

    International Nuclear Information System (INIS)

    Carlsson, Lennart

    1998-01-01

    This document reflects basic proposals derived from the discussions and results by the expert group on human performance within the frame of an OECD study on nuclear safety research. Different topics have identified which are herein briefly presented: cognitive models and errors of commission, organizational practices, validation of existing techniques for human reliability analysis, control room design and man-machine interactions, use of simulators, improvement of methods for evaluation of operating experience, safety culture, operator aids, shutdown, decommissioning

  19. Issues in protection of human subjects in internet research.

    Science.gov (United States)

    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.

  20. Ethics of animal research in human disease remediation, its institutional teaching; and alternatives to animal experimentation.

    Science.gov (United States)

    Cheluvappa, Rajkumar; Scowen, Paul; Eri, Rajaraman

    2017-08-01

    Animals have been used in research and teaching for a long time. However, clear ethical guidelines and pertinent legislation were instated only in the past few decades, even in developed countries with Judeo-Christian ethical roots. We compactly cover the basics of animal research ethics, ethical reviewing and compliance guidelines for animal experimentation across the developed world, "our" fundamentals of institutional animal research ethics teaching, and emerging alternatives to animal research. This treatise was meticulously constructed for scientists interested/involved in animal research. Herein, we discuss key animal ethics principles - Replacement/Reduction/Refinement. Despite similar undergirding principles across developed countries, ethical reviewing and compliance guidelines for animal experimentation vary. The chronology and evolution of mandatory institutional ethical reviewing of animal experimentation (in its pioneering nations) are summarised. This is followed by a concise rendition of the fundamentals of teaching animal research ethics in institutions. With the advent of newer methodologies in human cell-culturing, novel/emerging methods aim to minimise, if not avoid the usage of animals in experimentation. Relevant to this, we discuss key extant/emerging alternatives to animal use in research; including organs on chips, human-derived three-dimensional tissue models, human blood derivates, microdosing, and computer modelling of various hues. © 2017 The Authors. Pharmacology Research & Perspectives published by John Wiley & Sons Ltd, British Pharmacological Society and American Society for Pharmacology and Experimental Therapeutics.

  1. Contributions from assited human reproduction techniques' socio-legal research to the legislative field

    Directory of Open Access Journals (Sweden)

    Marisa Herrera

    2017-03-01

    Full Text Available This paper’s intention is to share some of the main results of two field-based research projects regarding assisted human reproduction practices in Argentina. Both projects have been developed in a dynamic legislative context involving medical coverage regulation, parentage determination and the right to know one's origins for children born with third party genetic material. Also, in this context, the Draft Civil and Commercial Code reform introduced two figures that were then removed in the parliamentary debate: post mortem fertilization and surrogate motherhood. All these issues concerning the use of assisted human reproduction challenge the legal field and are addressed in these research projects, one of them more from an explorative perspective and the other from a qualitative one. Therefore, this article aims to introduce some of the measured variables and the findings obtained to serve as relevant contributions to achieve a more appropriate legislation according with the medical and social reality.

  2. Enhancing the Ethical Conduct of HIV Research with Migrant Sex Workers: Human Rights, Policy, and Social Contextual Influences.

    Science.gov (United States)

    Goldenberg, Shira M; Brouwer, Kimberly C; Jimenez, Teresita Rocha; Miranda, Sonia Morales; Mindt, Monica Rivera

    2016-01-01

    Migrant sex workers are often highly marginalized and disproportionately experience health and social inequities, including high prevalence of HIV, sexually transmitted infections, and human rights violations. In recent years, research involving migrant sex workers has increased, yet many knowledge gaps remain regarding how best to protect research participant rights and welfare. Our objective was to identify key challenges and opportunities related to the responsible conduct of HIV research with migrant sex workers. Focus groups and interviews conducted with 33 female sex workers ≥18 years old at the Guatemala-Mexico border from June 2013-February 2014 were analyzed. Participants were recruited through community outreach by a local HIV prevention organization to sex work establishments such as bars, hotels, street corners, and truck stops. Key themes influencing research engagement for migrant sex workers included researcher mistrust and fear related to research participation, rooted in the social isolation frequently faced by recent migrants; intersecting concerns related to immigration status, fear of criminalization, and compliance with sex work regulations; and perceived benefits and risks of HIV/STI testing for migrants (e.g., immigration implications, stigma) represent potential barriers and opportunities for the responsible conduct of research involving migrant sex workers. Results highlight the intersection between the human rights vulnerabilities of migrant sex workers and barriers to research participation, including social isolation of migrants and policy/legal barriers related to immigration and sex work. Findings illustrate the need for researchers to develop population-tailored procedures to address fears related to immigration and criminalization, and to reinforce positive and non-stigmatizing relationships with migrant sex workers. Community-led efforts to reduce stigma and foster community organization and supports for migrant sex workers are

  3. Enhancing the Ethical Conduct of HIV Research with Migrant Sex Workers: Human Rights, Policy, and Social Contextual Influences.

    Directory of Open Access Journals (Sweden)

    Shira M Goldenberg

    Full Text Available Migrant sex workers are often highly marginalized and disproportionately experience health and social inequities, including high prevalence of HIV, sexually transmitted infections, and human rights violations. In recent years, research involving migrant sex workers has increased, yet many knowledge gaps remain regarding how best to protect research participant rights and welfare. Our objective was to identify key challenges and opportunities related to the responsible conduct of HIV research with migrant sex workers.Focus groups and interviews conducted with 33 female sex workers ≥18 years old at the Guatemala-Mexico border from June 2013-February 2014 were analyzed. Participants were recruited through community outreach by a local HIV prevention organization to sex work establishments such as bars, hotels, street corners, and truck stops.Key themes influencing research engagement for migrant sex workers included researcher mistrust and fear related to research participation, rooted in the social isolation frequently faced by recent migrants; intersecting concerns related to immigration status, fear of criminalization, and compliance with sex work regulations; and perceived benefits and risks of HIV/STI testing for migrants (e.g., immigration implications, stigma represent potential barriers and opportunities for the responsible conduct of research involving migrant sex workers.Results highlight the intersection between the human rights vulnerabilities of migrant sex workers and barriers to research participation, including social isolation of migrants and policy/legal barriers related to immigration and sex work. Findings illustrate the need for researchers to develop population-tailored procedures to address fears related to immigration and criminalization, and to reinforce positive and non-stigmatizing relationships with migrant sex workers. Community-led efforts to reduce stigma and foster community organization and supports for migrant

  4. Examination of Signatures of Recent Positive Selection on Genes Involved in Human Sialic Acid Biology.

    Science.gov (United States)

    Moon, Jiyun M; Aronoff, David M; Capra, John A; Abbot, Patrick; Rokas, Antonis

    2018-03-28

    Sialic acids are nine carbon sugars ubiquitously found on the surfaces of vertebrate cells and are involved in various immune response-related processes. In humans, at least 58 genes spanning diverse functions, from biosynthesis and activation to recycling and degradation, are involved in sialic acid biology. Because of their role in immunity, sialic acid biology genes have been hypothesized to exhibit elevated rates of evolutionary change. Consistent with this hypothesis, several genes involved in sialic acid biology have experienced higher rates of non-synonymous substitutions in the human lineage than their counterparts in other great apes, perhaps in response to ancient pathogens that infected hominins millions of years ago (paleopathogens). To test whether sialic acid biology genes have also experienced more recent positive selection during the evolution of the modern human lineage, reflecting adaptation to contemporary cosmopolitan or geographically-restricted pathogens, we examined whether their protein-coding regions showed evidence of recent hard and soft selective sweeps. This examination involved the calculation of four measures that quantify changes in allele frequency spectra, extent of population differentiation, and haplotype homozygosity caused by recent hard and soft selective sweeps for 55 sialic acid biology genes using publicly available whole genome sequencing data from 1,668 humans from three ethnic groups. To disentangle evidence for selection from confounding demographic effects, we compared the observed patterns in sialic acid biology genes to simulated sequences of the same length under a model of neutral evolution that takes into account human demographic history. We found that the patterns of genetic variation of most sialic acid biology genes did not significantly deviate from neutral expectations and were not significantly different among genes belonging to different functional categories. Those few sialic acid biology genes that

  5. Guidelines for human embryonic stem cell research

    National Research Council Canada - National Science Library

    Committee on Guidelines for Human Embryonic Stem Cell Research; National Research Council; Board on Health Sciences Policy; Institute of Medicine; Division on Earth and Life Studies; National Research Council

    2005-01-01

    .... Given limited federal involvement, privately funded hES cell research has thus far been carried out under a patchwork of existing regulations, many of which were not designed with this research specifically in mind...

  6. Fruit Flies Help Human Sleep Research

    Science.gov (United States)

    ... like us, without enough sleep, flies feel the effects of sleep deprivation. Cirelli has shown that they are a good model for researching human sleep. She has found fruit fly genes that seem to have a powerful effect on sleep. In time, her research could lead ...

  7. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: Results of a survey

    Directory of Open Access Journals (Sweden)

    Vale Claire L

    2012-01-01

    Full Text Available Abstract Background We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs, meta-analyses and other studies carried out by the UK Medical Research Council (MRC Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Methods Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009 were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Results Between October 2009 and April 2010, 138 completed questionnaires (86% were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31% had some consumer involvement, most commonly as members of trial management groups (TMG [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Conclusions Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development

  8. Involvement of consumers in studies run by the Medical Research Council Clinical Trials Unit: results of a survey.

    Science.gov (United States)

    Vale, Claire L; Thompson, Lindsay C; Murphy, Claire; Forcat, Silvia; Hanley, Bec

    2012-01-13

    We aimed to establish levels of consumer involvement in randomised controlled trials (RCTs), meta-analyses and other studies carried out by the UK Medical Research Council (MRC) Clinical Trials Unit across the range of research programs, predominantly in cancer and HIV. Staff responsible for studies that were included in a Unit Progress Report (MRC CTU, April 2009) were asked to complete a semi-structured questionnaire survey regarding consumer involvement. This was defined as active involvement of consumers as partners in the research process and not as subjects of that research. The electronic questionnaires combined open and closed questions, intended to capture quantitative and qualitative information on whether studies had involved consumers; types of activities undertaken; recruitment and support; advantages and disadvantages of involvement and its perceived impact on aspects of the research. Between October 2009 and April 2010, 138 completed questionnaires (86%) were returned. Studies had been conducted over a 20 year period from 1989, and around half were in cancer; 30% in HIV and 20% were in other disease areas including arthritis, tuberculosis and blood transfusion medicine. Forty-three studies (31%) had some consumer involvement, most commonly as members of trial management groups (TMG) [88%]. A number of positive impacts on both the research and the researcher were identified. Researchers generally felt involvement was worthwhile and some felt that consumer involvement had improved the credibility of the research. Benefits in design and quality, trial recruitment, dissemination and decision making were also perceived. Researchers felt they learned from consumer involvement, albeit that there were some barriers. Whilst most researchers identified benefits of involving consumers, most of studies included in the survey had no involvement. Information from this survey will inform the development of a unit policy on consumer involvement, to guide future

  9. Involving Research Stakeholders in Developing Policy on Sharing Public Health Research Data in Kenya

    Science.gov (United States)

    Jao, Irene; Kombe, Francis; Mwalukore, Salim; Bull, Susan; Parker, Michael; Kamuya, Dorcas; Molyneux, Sassy

    2015-01-01

    Increased global sharing of public health research data has potential to advance scientific progress but may present challenges to the interests of research stakeholders, particularly in low-to-middle income countries. Policies for data sharing should be responsive to public views, but there is little evidence of the systematic study of these from low-income countries. This qualitative study explored views on fair data-sharing processes among 60 stakeholders in Kenya with varying research experience, using a deliberative approach. Stakeholders’ attitudes were informed by perceptions of benefit and concerns for research data sharing, including risks of stigmatization, loss of privacy, and undermining scientific careers and validity, reported in detail elsewhere. In this article, we discuss institutional trust-building processes seen as central to perceptions of fairness in sharing research data in this setting, including forms of community involvement, individual prior awareness and agreement to data sharing, independence and accountability of governance mechanisms, and operating under a national framework. PMID:26297748

  10. 77 FR 2735 - National Human Genome Research Institute; Notice of Meetings

    Science.gov (United States)

    2012-01-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... personal privacy. Name of Committee: National Advisory Council for Human Genome Research. Date: February 13... Extramural Research National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9305...

  11. 75 FR 51828 - National Human Genome Research Institute; Notice of Meetings

    Science.gov (United States)

    2010-08-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... personal privacy. Name of Committee: National Advisory Council for Human Genome Research. Date: February 7... Research, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9305, Bethesda, MD...

  12. Consumer and community involvement in health and medical research: evaluation by online survey of Australian training workshops for researchers

    OpenAIRE

    McKenzie, Anne; Alpers, Kirsten; Heyworth, Jane; Phuong, Cindy; Hanley, Bec

    2016-01-01

    Plain English Summary In Australia, since 2009, the Consumer and Community Involvement Program (formerly the Consumer and Community Participation Program) has developed and run workshops to help people working in health and medical research involve more consumers (patients) and community members (the public) in their research. In 2012, workshop attendees were invited to do an online survey to find out the effect, if any, that attending a workshop had on their awareness of and attitudes to con...

  13. Co-researching with people with learning disabilities: an experience of involvement in qualitative data analysis.

    Science.gov (United States)

    Tuffrey-Wijne, Irene; Butler, Gary

    2010-06-01

    People with learning disabilities have been included in research as co-researchers since the 1990s. However, there is limited literature about the processes of involving people with learning disabilities in the more intellectual and analytical stages of the research process. To examine the potential contribution of people with learning disabilities to data analysis in qualitative research. This article is a reflection on one research experience. The two authors include one researcher with and one without learning disabilities. They each describe their experience and understanding of user involvement in analysing the data of an ethnographic study of people with learning disabilities who had cancer. The researcher with learning disabilities was given extensive vignettes and extracts from the research field notes, and was supported to extract themes, which were cross-compared with the analysis of other members of the research team. The researcher with learning disabilities coped well with the emotive content of the data and with the additional support provided, he was able to extract themes that added validity to the overall analysis. His contribution complemented those of the other members of the research team. There were unexpected benefits, in particular, in terms of a more reciprocal and supportive relationship between the two researchers. It is possible and valuable to extend involvement to data analysis, but to avoid tokenism and maintain academic rigour, there must be a clear rationale for such involvement. Extra support, time and costs must be planned for.

  14. Communication Capacity Research in the Majority World: Supporting the human right to communication specialist services.

    Science.gov (United States)

    Hopf, Suzanne C

    2018-02-01

    Receipt of accessible and appropriate specialist services and resources by all people with communication and/or swallowing disability is a human right; however, it is a right rarely achieved in either Minority or Majority World contexts. This paper considers communication specialists' efforts to provide sustainable services for people with communication difficulties living in Majority World countries. The commentary draws on human rights literature, particularly Article 19 of the Universal Declaration of Human Rights and the Communication Capacity Research program that includes: (1) gathering knowledge from policy and literature; (2) gathering knowledge from the community; (3) understanding speech, language and literacy use and proficiency; and (4) developing culturally and linguistically appropriate resources and assessments. To inform the development of resources and assessments that could be used by speech-language pathologists as well as other communication specialists in Fiji, the Communication Capacity Research program involved collection and analysis of data from multiple sources including 144 community members, 75 school students and their families, and 25 teachers. The Communication Capacity Research program may be applicable for achieving the development of evidence-based, culturally and linguistically sustainable SLP services in similar contexts.

  15. Power to the people: To what extent has public involvement in applied health research achieved this?

    Science.gov (United States)

    Green, Gill

    2016-01-01

    Public involvement is required for applied health research funded in the UK. One of the largest funders, the National Institute of Health Research (NIHR), makes it clear that it values the knowledge of patients and the public. As a result, there are now many resources to make sure that the public voice is included in decision-making about research. However, there is concern that the public voice still has limited impact on research decision-making. This article asks to what extent has power shifted from the scientific research community to the public? It looks at how much power and impact patients and members of the public have about research by asking: How do the public contribute to deciding which research areas and which research projects should be funded? How do they influence how the research is carried out? The article argues that there is evidence that the public voice is present in research decision-making. However, there is less evidence of a change in the power dynamic between the scientific research community and the public. The public involved in research are not always equal partners. The scientific research community still has the loudest voice and patients and the public do not always feel sufficiently empowered to challenge it. Public involvement in applied health research is a pre-requisite for funding from many funding bodies. In particular the National Institute of Health Research (NIHR) in the UK, clearly states that it values lay knowledge and there is an expectation that members of the public will participate as research partners in research. As a result a large public involvement infrastructure has emerged to facilitate this. However, there is concern that despite the flurry of activity in promoting public involvement, lay knowledge is marginalised and has limited impact on research decision-making. This article asks to what extent has power shifted from the scientific research community to the public? It discusses the meaning of power and

  16. Genes Involved in Human Ribosome Biogenesis areTranscriptionally Upregulated in Colorectal Cancer

    DEFF Research Database (Denmark)

    Mansilla, Francisco; Lamy, Philippe; Ørntoft, Torben Falck

    2009-01-01

    Microarray gene expression profiling comprising 168 colorectal adenocarcinomas and 10 normal mucosas showed that over 79% of the genes involved in human ribosome biogenesis are significantly upregulated (log2>0.5, p<10-3) when compared to normal mucosa. Overexpression was independent of microsate......Microarray gene expression profiling comprising 168 colorectal adenocarcinomas and 10 normal mucosas showed that over 79% of the genes involved in human ribosome biogenesis are significantly upregulated (log2>0.5, p... of microsatellite status. The promoters of the genes studied showed a significant enrichment for several transcription factor binding sites. There was a significant correlation between the number of binding site targets for these transcription factors and the observed gene transcript upregulation. The upregulation...

  17. 75 FR 2147 - National Human Genome Research Institute; Notice of Meetings

    Science.gov (United States)

    2010-01-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Council for Human Genome Research. The meetings will be open to the public as indicated below, with... Extramural Research, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9305...

  18. Collaborative Research in the Digital Humanities

    CERN Document Server

    Deegan, Marilyn

    2012-01-01

    Collaboration within digital humanities is both a pertinent and a pressing topic as the traditional mode of the humanist, working alone in his or her study, is supplemented by explicitly co-operative, interdependent and collaborative research. This is particularly true where computational methods are employed in large-scale digital humanities projects. This book, which celebrates the contributions of Harold Short to this field, presents fourteen essays by leading authors in the digital humanities. It addresses several issues of collaboration, from the multiple perspectives of institutions, pro

  19. 3 CFR 13505 - Executive Order 13505 of March 9, 2009. Removing Barriers to Responsible Scientific Research...

    Science.gov (United States)

    2010-01-01

    ... Barriers to Responsible Scientific Research Involving Human Stem Cells 13505 Order 13505 Presidential... Scientific Research Involving Human Stem Cells By the authority vested in me as President by the Constitution.... Research involving human embryonic stem cells and human non-embryonic stem cells has the potential to lead...

  20. Human Trafficking and Sexual Servitude: Organised Crime’s Involvement in Australia

    Directory of Open Access Journals (Sweden)

    Mark Langhorn

    2018-03-01

    Full Text Available This study examined the context of organised crime groups that traffic in people for the Australian sex industry. It is a qualitative study of twenty-one cases of human trafficking. The study found that criminal networks preyed on vulnerable females from countries such as Thailand, South Korea, and China. Victims were deceptively recruited with the cost of their travel to Australia held against them as a highly inflated debt. As a result, they find themselves forced into sex work to repay the debt. This study examined the attributes of the organised crime syndicates involved in the people trafficking and discussed the context in which they operate in Australia. The study used the Sleipnir framework to analyse organised crime groups and it is recommended that the Sleipnir model is integrated into future law enforcement activities in respect of human trafficking. The introduction of a standardised data and statistical collection tool in respect of human trafficking would provide law enforcement and intelligence agencies with a conceptual framework and a greater comprehensive description of human trafficking.

  1. Ethical fundamentals in human subjects research : On equipoise and human dignity

    NARCIS (Netherlands)

    van der Graaf - Verhave, R.

    2010-01-01

    In her PhD thesis Rieke van der Graaf has studied how we can ethically justify human subjects research. In particular she has studied two ethical fundamentals that play a key role in the justification process, that of equipoise and human dignity. Equipoise is often taken to mean that

  2. Using non-human primates to benefit humans: research and organ transplantation.

    Science.gov (United States)

    Shaw, David; Dondorp, Wybo; de Wert, Guido

    2014-11-01

    Emerging biotechnology may soon allow the creation of genetically human organs inside animals, with non-human primates (henceforth simply "primates") and pigs being the best candidate species. This prospect raises the question of whether creating organs in primates in order to then transplant them into humans would be more (or less) acceptable than using them for research. In this paper, we examine the validity of the purported moral distinction between primates and other animals, and analyze the ethical acceptability of using primates to create organs for human use.

  3. How embedded is public involvement in mainstream health research in England a decade after policy implementation? A realist evaluation.

    Science.gov (United States)

    Wilson, Patricia; Mathie, Elspeth; Poland, Fiona; Keenan, Julia; Howe, Amanda; Munday, Diane; Kendall, Sally; Cowe, Marion; Staniszewska, Sophie; Goodman, Claire

    2018-04-01

    Objectives To explore how embedded patient and public involvement is within mainstream health research following two decades of policy-driven work to underpin health research with patient and public involvement in England. Methods Realist evaluation using Normalization Process Theory as a programme theory to understand what enabled patient and public involvement to be embedded as normal practice. Data were collected through a national scoping and survey, and qualitative methods to track patient and public involvement processes and impact over time within 22 nationally funded research projects. Results In research studies that were able to create reciprocal working relationships and to embed patient and public involvement this was contingent on: the purpose of patient and public involvement being clear; public contributors reflecting research end-beneficiaries; researchers understanding the value of patient and public involvement; patient and public involvement opportunities being provided throughout the research and ongoing evaluation of patient and public involvement. Key contested areas included: whether to measure patient and public involvement impact; seeking public contributors to maintain a balance between being research-aware and an outsider standpoint seen as 'authentically' lay; scaling-up patient and public involvement embedded within a research infrastructure rather than risk token presence and whether patient and public involvement can have a place within basic science. Conclusions While patient and public involvement can be well-integrated within all types of research, policy makers should take account of tensions that must be navigated in balancing moral and methodological imperatives.

  4. 76 FR 54408 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing...

    Science.gov (United States)

    2011-09-01

    ... and Drug Administration 21 CFR Parts 50 and 56 Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing Burden, Delay, and Ambiguity for Investigators; Extension of... Secretary of the Department of Health and Human Services (HHS) in coordination with the Office of Science...

  5. Researching Human Experience: video intervention/prevention assessment (VIA

    Directory of Open Access Journals (Sweden)

    Jennifer Patashnick

    2005-05-01

    Full Text Available Human experience is a critical subject for research. By discussing Video Intervention/Prevention Assessment (VIA, a patient-centered health research method where patients teach their clinicians about living with a chronic condition through the creation of visual illness narratives, this paper examines the value of qualitative inquiry and why human experience rarely is investigated directly. An analysis of a sample VIA data is presented to demonstrate how, by utilizing grounded theory and qualitative analysis, one can derive rich and unique information from human experience.

  6. Guidelines for human embryonic stem cell research

    National Research Council Canada - National Science Library

    Committee on Guidelines for Human Embryonic Stem Cell Research, National Research Council

    2005-01-01

    Since 1998, the volume of research being conducted using human embryonic stem (hES) cells has expanded primarily using private funds because of restrictions on the use of federal funds for such research...

  7. Literature search and review of research involving radioisotopes conducted by Dr. G.E. Burch at Charity Hospital in New Orleans, Louisiana under the auspices of Tulane University during the 1940s,1950s, and 1960s

    International Nuclear Information System (INIS)

    Brooks, F.; Curtis, E.C.; Forrester, G.; Roth, V.; Spickard, J.; Webster, B.; Engle, J.; Perkins, L.; Powell, S.

    1994-01-01

    This report presents a synopsis of research performed by Dr. G.E. Burch during the 1940s, 1950s, and 1960s at Charity Hospital in New Orleans, Louisiana. Four technical experts have reviewed twenty-seven research published in peer-reviewed research journals and proceedings by Dr. Burch and his colleagues between the years 1946 and 1968. The papers were grouped prior to the review into three categories represented in this report by the following chapter titles: Studies Involving Human Subjects; Isotopic Studies Not Involving Human or Canine Subjects; and Studies Involving Dogs as Test Models. The experts' reviews addressed five areas. What, if Any, Is the Scientific Value of the Research on Which These Studies Are Based?; Did the Research Provide Medicine with New and Useful Information?; What Contributions Did This Research Make to Patient Care or to the Understanding of the Disease Process?; What Was Known Medically about Matters Addressed by This Research at the Time It Was Being Conducted? and Is There Documentation That Shows Informed Consent?

  8. Involving Communities in Deciding What Benefits They Receive in Multinational Research.

    Science.gov (United States)

    Wendler, David; Shah, Seema

    2015-10-01

    There is wide agreement that communities in lower-income countries should benefit when they participate in multinational research. Debate now focuses on how and to what extent these communities should benefit. This debate has identified compelling reasons to reject the claim that whatever benefits a community agrees to accept are necessarily fair. Yet, those who conduct clinical research may conclude from this rejection that there is no reason to involve communities in the process of deciding how they benefit. Against this possibility, the present manuscript argues that involving host communities in this process helps to promote four important goals: (1) protecting host communities, (2) respecting host communities, (3) promoting transparency, and (4) enhancing social value. Published by Oxford University Press on behalf of the Journal of Medicine and Philosophy, Inc. 2015.

  9. "Who owns your poop?": insights regarding the intersection of human microbiome research and the ELSI aspects of biobanking and related studies.

    Science.gov (United States)

    Hawkins, Alice K; O'Doherty, Kieran C

    2011-10-07

    While the social, ethical, and legal implications of biobanking and large scale data sharing are already complicated enough, they may be further compounded by research on the human microbiome. The human microbiome is the entire complement of microorganisms that exists in and on every human body. Currently most biobanks focus primarily on human tissues and/or associated data (e.g. health records). Accordingly, most discussions in the social sciences and humanities on these issues are focused (appropriately so) on the implications of biobanks and sharing data derived from human tissues. However, rapid advances in human microbiome research involve collecting large amounts of data on microorganisms that exist in symbiotic relationships with the human body. Currently it is not clear whether these microorganisms should be considered part of or separate from the human body. Arguments can be made for both, but ultimately it seems that the dichotomy of human versus non-human and self versus non-self inevitably breaks down in this context. This situation has the potential to add further complications to debates on biobanking. In this paper, we revisit some of the core problem areas of privacy, consent, ownership, return of results, governance, and benefit sharing, and consider how they might be impacted upon by human microbiome research. Some of the issues discussed also have relevance to other forms of microbial research. Discussion of these themes is guided by conceptual analysis of microbiome research and interviews with leading Canadian scientists in the field.

  10. Involving the public in mental health and learning disability research: Can we, should we, do we?

    Science.gov (United States)

    Paul, C; Holt, J

    2017-10-01

    WHAT IS KNOWN ON THE SUBJECT?: UK health policy is clear that researchers should involve the public throughout the research process. The public, including patients, carers and/or local citizens can bring a different and valuable perspective to the research process and improve the quality of research undertaken. Conducting health research is demanding with tight deadlines and scarce resources. This can make involving the public in research very challenging. WHAT THIS PAPER ADDS TO EXISTING KNOWLEDGE?: This is the first time the attitudes of researchers working in mental health and learning disability services towards PPI have been investigated. The principles of service user involvement in mental health and learning disability services may support PPI in research as a tool of collaboration and empowerment. This article extends our understanding of the cultural and attitudinal barriers to implementing PPI guidelines in mental health and learning disability services. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: Researchers in mental health and learning disability services need to champion, share and publish effective involvement work. Structural barriers to PPI work should be addressed locally and successful strategies shared nationally and internationally. Where PPI guidelines are being developed, attention needs to be paid to cultural factors in the research community to win "hearts and minds" and support the effective integration of PPI across the whole research process. Introduction Patient and public involvement (PPI) is integral to UK health research guidance; however, implementation is inconsistent. There is little research into the attitudes of NHS health researchers towards PPI. Aim This study explored the attitude of researchers working in mental health and learning disability services in the UK towards PPI in health research. Method Using a qualitative methodology, semi-structured interviews were conducted with a purposive sample of eight researchers. A

  11. Clinical Trials: A Crucial Key to Human Health Research

    Science.gov (United States)

    ... Past Issues Clinical Trials: A Crucial Key to Human Health Research Past Issues / Summer 2006 Table of Contents ... Javascript on. Photo: PhotoDisc At the forefront of human health research today are clinical trials—studies that use ...

  12. Benefiting from 'evil': an incipient moral problem in human stem cell research.

    Science.gov (United States)

    Green, Ronald M

    2002-11-01

    When does benefiting from others' wrongdoing effectively make one a moral accomplice in their evil deeds? If stem cell research lives up to its therapeutic promise, this question (which has previously cropped up in debates over fetal tissue research or the use of Nazi research data) is likely to become a central one for opponents of embryo destruction. I argue that benefiting from wrongdoing is prima facie morally wrong under any of three conditions: (1) when the wrongdoing is one's agent; (2) when acceptance of benefit directly encourages the repetition of the wrongful deed (even though no agency relationship is involved); and (3) when acceptance of a benefit legitimates a wrongful practice. I conclude by showing that, because of the ways in which most embryonic stem cell lines come into being, people who oppose embryo destruction may use human embryonic stem cells without incurring moral blame.

  13. The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

    Directory of Open Access Journals (Sweden)

    London Leslie

    2010-08-01

    Full Text Available Abstract The controversy about the use of data from human volunteer studies involving experimental exposure to pesticides as part of regulatory risk assessment has been widely discussed, but the complex and interrelated scientific and ethical issues remain largely unresolved. This discussion paper, generated by authors who comprised a workgroup of the ICOH Scientific Committee on Rural Health, reviews the use of human experimental studies in regulatory risk assessment for pesticides with a view to advancing the debate as to when, if ever, such studies might be ethically justifiable. The discussion is based on three elements: (a a review of discussion papers on the topic of human testing of pesticides and the positions adopted by regulatory agencies in developed countries; (b an analysis of published and unpublished studies involving human testing with pesticides, both in the peer-reviewed literature and in the JMPR database; and (c application of an ethical analysis to the problem. The paper identifies areas of agreement which include general principles that may provide a starting point on which to base criteria for judgements as to the ethical acceptability of such studies. However, the paper also highlights ongoing unresolved differences of opinion inherent in ethical analysis of contentious issues, which we propose should form a starting point for further debate and the development of guidelines to achieve better resolution of this matter.

  14. The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas.

    Science.gov (United States)

    London, Leslie; Coggon, David; Moretto, Angelo; Westerholm, Peter; Wilks, Martin F; Colosio, Claudio

    2010-08-18

    The controversy about the use of data from human volunteer studies involving experimental exposure to pesticides as part of regulatory risk assessment has been widely discussed, but the complex and interrelated scientific and ethical issues remain largely unresolved. This discussion paper, generated by authors who comprised a workgroup of the ICOH Scientific Committee on Rural Health, reviews the use of human experimental studies in regulatory risk assessment for pesticides with a view to advancing the debate as to when, if ever, such studies might be ethically justifiable. The discussion is based on three elements: (a) a review of discussion papers on the topic of human testing of pesticides and the positions adopted by regulatory agencies in developed countries; (b) an analysis of published and unpublished studies involving human testing with pesticides, both in the peer-reviewed literature and in the JMPR database; and (c) application of an ethical analysis to the problem. The paper identifies areas of agreement which include general principles that may provide a starting point on which to base criteria for judgements as to the ethical acceptability of such studies. However, the paper also highlights ongoing unresolved differences of opinion inherent in ethical analysis of contentious issues, which we propose should form a starting point for further debate and the development of guidelines to achieve better resolution of this matter.

  15. The ethics of human volunteer studies involving experimental exposure to pesticides: unanswered dilemmas

    Science.gov (United States)

    2010-01-01

    The controversy about the use of data from human volunteer studies involving experimental exposure to pesticides as part of regulatory risk assessment has been widely discussed, but the complex and interrelated scientific and ethical issues remain largely unresolved. This discussion paper, generated by authors who comprised a workgroup of the ICOH Scientific Committee on Rural Health, reviews the use of human experimental studies in regulatory risk assessment for pesticides with a view to advancing the debate as to when, if ever, such studies might be ethically justifiable. The discussion is based on three elements: (a) a review of discussion papers on the topic of human testing of pesticides and the positions adopted by regulatory agencies in developed countries; (b) an analysis of published and unpublished studies involving human testing with pesticides, both in the peer-reviewed literature and in the JMPR database; and (c) application of an ethical analysis to the problem. The paper identifies areas of agreement which include general principles that may provide a starting point on which to base criteria for judgements as to the ethical acceptability of such studies. However, the paper also highlights ongoing unresolved differences of opinion inherent in ethical analysis of contentious issues, which we propose should form a starting point for further debate and the development of guidelines to achieve better resolution of this matter. PMID:20718963

  16. Protecting human research subjects: the past defines the future.

    Science.gov (United States)

    Breault, Joseph L

    2006-01-01

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

  17. Public involvement in research within care homes: benefits and challenges in the APPROACH study.

    Science.gov (United States)

    Froggatt, Katherine; Goodman, Claire; Morbey, Hazel; Davies, Sue L; Masey, Helen; Dickinson, Angela; Martin, Wendy; Victor, Christina

    2016-12-01

    Public involvement in research (PIR) can improve research design and recruitment. Less is known about how PIR enhances the experience of participation and enriches the data collection process. In a study to evaluate how UK care homes and primary health-care services achieve integrated working to promote older people's health, PIR was integrated throughout the research processes. This paper aims to present one way in which PIR has been integrated into the design and delivery of a multisite research study based in care homes. A prospective case study design, with an embedded qualitative evaluation of PIR activity. Data collection was undertaken in six care homes in three sites in England. Six PIR members participated: all had prior personal or work experience in care homes. Qualitative data collection involved discussion groups, and site-specific meetings to review experiences of participation, benefits and challenges, and completion of structured fieldwork notes after each care home visit. PIR members supported recruitment, resident and staff interviews and participated in data interpretation. Benefits of PIR work were resident engagement that minimized distress and made best use of limited research resources. Challenges concerned communication and scheduling. Researcher support for PIR involvement was resource intensive. Clearly defined roles with identified training and support facilitated involvement in different aspects of the data collection process. This can also ensure that vulnerable older people who participate in research have a positive experience that reinforces the value of their views. © 2015 The Authors Health Expectations Published by John Wiley & Sons Ltd.

  18. Biomedical research on the International Space Station postural and manipulation problems of the human upper limb in weightlessness

    Science.gov (United States)

    Neri, Gianluca; Zolesi, Valfredo

    2000-01-01

    Accumulated evidence, based on information gathered on space flight missions and ground based models involving both humans and animals, clearly suggests that exposure to states of microgravity conditions for varying duration induces certain physiological changes; they involve cardiovascular deconditioning, balance disorders, bone weakening, muscle hypertrophy, disturbed sleep patterns and depressed immune responses. The effects of the microgravity on the astronauts' movement and attitude have been studied during different space missions, increasing the knowledge of the human physiology in weightlessness. The purpose of the research addressed in the present paper is to understand and to assess the performances of the upper limb, especially during grasp. Objects of the research are the physiological changes related to the long-term duration spaceflight environment. Specifically, the changes concerning the upper limb are investigated, with particular regard to the performances of the hand in zero-g environments. This research presents also effects on the Earth, improving the studies on a number of pathological states, on the health care and the rehabilitation. In this perspective, a set of experiments are proposed, aimed at the evaluation of the effects of the zero-g environments on neurophysiology of grasping movements, fatigue assessment, precision grip. .

  19. Usability: Human Research Program - Space Human Factors and Habitability

    Science.gov (United States)

    Sandor, Aniko; Holden, Kritina L.

    2009-01-01

    The Usability project addresses the need for research in the area of metrics and methodologies used in hardware and software usability testing in order to define quantifiable and verifiable usability requirements. A usability test is a human-in-the-loop evaluation where a participant works through a realistic set of representative tasks using the hardware/software under investigation. The purpose of this research is to define metrics and methodologies for measuring and verifying usability in the aerospace domain in accordance with FY09 focus on errors, consistency, and mobility/maneuverability. Usability metrics must be predictive of success with the interfaces, must be easy to obtain and/or calculate, and must meet the intent of current Human Systems Integration Requirements (HSIR). Methodologies must work within the constraints of the aerospace domain, be cost and time efficient, and be able to be applied without extensive specialized training.

  20. The Article Idea Chart: A participatory action research tool to aid involvement in dissemination

    Directory of Open Access Journals (Sweden)

    Cheryl Forchuk

    2014-06-01

    Full Text Available Participatory-action research encourages the involvement of all key stakeholders in the research process and is especially well suited to mental health research. Previous literature outlines the importance of engaging stakeholders in the development of research questions and methodologies, but little has been written about ensuring the involvement of all stakeholders (especially non-academic members in dissemination opportunities such as publication development. The Article Idea Chart was developed as a specific methodology for engaging all stakeholders in data analysis and publication development. It has been successfully utilised in a number of studies and is an effective tool for ensuring the dissemination process of participatory-action research results is both inclusive and transparent to all team members, regardless of stakeholder group. Keywords: participatory-action research, mental health, dissemination, community capacity building, publications, authorship

  1. Research Attitudes and Involvement among Medical Students and Students of Allied Health Occupations.

    Science.gov (United States)

    Delin, Catherine R.

    1994-01-01

    Medicine has a long research tradition, whereas allied health areas have only recently become involved in research. A questionnaire study was conducted to investigate the attitudes to research of a total of 314 students of medicine, dentistry, occupational therapy, physiotherapy, and nursing courses on the city campuses of two South Australian…

  2. Trust in health research relationships: accounts of human subjects.

    Science.gov (United States)

    McDonald, Michael; Townsend, Anne; Cox, Susan M; Paterson, Natasha Damiano; Lafrenière, Darquise

    2008-12-01

    TRUST IS FUNDAMENTAL in health research, yet there is little empirical evidence that explores the meaning of trust from the perspective of human subjects. The analysis presented here focuses on how human subjects talked about trust in the in-depth interviews. It emerged from the accounts that trust could not be assumed in the research setting, rather it was portrayed as a dynamic concept, built and easily broken, characterized by reciprocity and negotiation. Human subjects were ambivalent about who, when, what, and how much to trust in the research endeavor. This paper adds a fresh perspective to the literature on trust, and so offers a currently neglected, and little understood dimension to the discourse around health research ethics.

  3. Human Resources for Health Research in Africa | IDRC ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Human Resources for Health Research in Africa ... the management of research systems for optimal use of results;; packaging research for policymakers; ... Call for new OWSD Fellowships for Early Career Women Scientists now open.

  4. The social value of clinical research.

    Science.gov (United States)

    Habets, Michelle G J L; van Delden, Johannes J M; Bredenoord, Annelien L

    2014-09-05

    International documents on ethical conduct in clinical research have in common the principle that potential harms to research participants must be proportional to anticipated benefits. The anticipated benefits that can justify human research consist of direct benefits to the research participant, and societal benefits, also called social value. In first-in-human research, no direct benefits are expected and the benefit component of the risks-benefit assessment thus merely exists in social value. The concept social value is ambiguous by nature and is used in numerous ways in the research ethics literature. Because social value justifies involving human participants, especially in early human trials, this is problematic. Our analysis and interpretation of the concept social value has led to three proposals. First, as no direct benefits are expected for the research participants in first-in-human trials, we believe it is better to discuss a risk- value assessment instead of a risk - benefit assessment. This will also make explicit the necessity to have a clear and common use for the concept social value. Second, to avoid confusion we propose to limit the concept social value to the intervention tested. It is the expected improvement the intervention can bring to the wellbeing of (future) patients or society that is referred to when we speak about social value. For the sole purpose of gaining knowledge, we should not expose humans to potential harm; the ultimate justification of involving humans in research lies in the anticipated social value of the intervention. Third, at the moment only the validity of the clinical research proposal is a prerequisite for research to take place. We recommend making the anticipated social value a prerequisite as well. In this paper we analyze the use of the concept social value in research ethics. Despite its unavoidable ambiguity, we aim to find a best use of the concept, subject to its role in justifying involving humans in first-in-human

  5. Uterine transplantation: Review in human research.

    Science.gov (United States)

    Favre-Inhofer, A; Rafii, A; Carbonnel, M; Revaux, A; Ayoubi, J M

    2018-06-01

    Uterine transplantation is the solution to treat absolute uterine fertility. In this review, we present the historical, medical, technical, psychological and ethical perspectives in human uterine transplantation research. We reviewed the PubMed database following PRISMA guidelines and added data presented by several research teams during the first international congress on uterine transplantation. Copyright © 2018. Published by Elsevier Masson SAS.

  6. "Who owns your poop?": insights regarding the intersection of human microbiome research and the ELSI aspects of biobanking and related studies

    Directory of Open Access Journals (Sweden)

    O'Doherty Kieran C

    2011-10-01

    Full Text Available Abstract Background While the social, ethical, and legal implications of biobanking and large scale data sharing are already complicated enough, they may be further compounded by research on the human microbiome. Discussion The human microbiome is the entire complement of microorganisms that exists in and on every human body. Currently most biobanks focus primarily on human tissues and/or associated data (e.g. health records. Accordingly, most discussions in the social sciences and humanities on these issues are focused (appropriately so on the implications of biobanks and sharing data derived from human tissues. However, rapid advances in human microbiome research involve collecting large amounts of data on microorganisms that exist in symbiotic relationships with the human body. Currently it is not clear whether these microorganisms should be considered part of or separate from the human body. Arguments can be made for both, but ultimately it seems that the dichotomy of human versus non-human and self versus non-self inevitably breaks down in this context. This situation has the potential to add further complications to debates on biobanking. Summary In this paper, we revisit some of the core problem areas of privacy, consent, ownership, return of results, governance, and benefit sharing, and consider how they might be impacted upon by human microbiome research. Some of the issues discussed also have relevance to other forms of microbial research. Discussion of these themes is guided by conceptual analysis of microbiome research and interviews with leading Canadian scientists in the field.

  7. Justice in human research ethics. A conceptual and practical guide.

    Science.gov (United States)

    Pieper, Ian; Thomson, Colin J H

    2013-03-01

    One of the core values to be applied by a body reviewing the ethics of human research is justice. The inclusion of justice as a requirement in the ethical review of human research is relatively recent and its utility had been largely unexamined until debates arose about the conduct of international biomedical research in the late 1990s. The subsequent amendment of authoritative documents in ways that appeared to shift the meaning of conceptions of justice generated a great deal of controversy. Another difficulty has been that both the theory and the substance of justice that are applied by researchers or reviewers can be frequently seen to be subjective. Both the concept of justice--hether distributive or commutative--and what counts as a just distribution or exchange--are given different weight and meanings by different people. In this paper, the origins and more recent debates about the requirement to consider justice as a criterion in the ethical review of human research are traced, relevant conceptions of justice are distinguished, and the manner in which they can be applied meaningfully in the ethical review of all human research is identified. We also explain the way that these concepts are articulated in, and the intent and function of, specific paragraphs of the National Statement on Ethical Conduct in Human Research (2007). The National Statement identifies a number of issues that should be considered when a human research ethics committee is reviewing the justice aspects of an application. We provide guidance to researchers as to how they can show that there is a fair distribution of burdens and benefits in the participant experience and the research outcomes. We also provide practical guidance to researches on how to think through issues of justice so that they can demonstrate that the design of their research projects meets this ethical requirement.

  8. Involving People with Lived Experience of Homelessness in Electronic Health Records Research

    Directory of Open Access Journals (Sweden)

    Serena Luchenski

    2017-04-01

    Using a participatory and dynamic approach to involve people with lived experience of homelessness and exclusion is an effective public engagement methodology for complex topics such as EHR research and data linkage. Information provided in the workshop was useful for interpreting findings, identifying strengths and gaps in health and social services, and developing research and practice recommendations.

  9. Proteomics research in India: an update.

    Science.gov (United States)

    Reddy, Panga Jaipal; Atak, Apurva; Ghantasala, Saicharan; Kumar, Saurabh; Gupta, Shabarni; Prasad, T S Keshava; Zingde, Surekha M; Srivastava, Sanjeeva

    2015-09-08

    After a successful completion of the Human Genome Project, deciphering the mystery surrounding the human proteome posed a major challenge. Despite not being largely involved in the Human Genome Project, the Indian scientific community contributed towards proteomic research along with the global community. Currently, more than 76 research/academic institutes and nearly 145 research labs are involved in core proteomic research across India. The Indian researchers have been major contributors in drafting the "human proteome map" along with international efforts. In addition to this, virtual proteomics labs, proteomics courses and remote triggered proteomics labs have helped to overcome the limitations of proteomics education posed due to expensive lab infrastructure. The establishment of Proteomics Society, India (PSI) has created a platform for the Indian proteomic researchers to share ideas, research collaborations and conduct annual conferences and workshops. Indian proteomic research is really moving forward with the global proteomics community in a quest to solve the mysteries of proteomics. A draft map of the human proteome enhances the enthusiasm among intellectuals to promote proteomic research in India to the world.This article is part of a Special Issue entitled: Proteomics in India. Copyright © 2015 Elsevier B.V. All rights reserved.

  10. Enhancing Interdisciplinary Human System Risk Research Through Modeling and Network Approaches

    Science.gov (United States)

    Mindock, Jennifer; Lumpkins, Sarah; Shelhamer, Mark

    2015-01-01

    NASA's Human Research Program (HRP) supports research to reduce human health and performance risks inherent in future human space exploration missions. Understanding risk outcomes and contributing factors in an integrated manner allows HRP research to support development of efficient and effective mitigations from cross-disciplinary perspectives, and to enable resilient human and engineered systems for spaceflight. The purpose of this work is to support scientific collaborations and research portfolio management by utilizing modeling for analysis and visualization of current and potential future interdisciplinary efforts.

  11. A comparative analysis of biomedical research ethics regulation systems in Europe and Latin America with regard to the protection of human subjects.

    Science.gov (United States)

    Lamas, Eugenia; Ferrer, Marcela; Molina, Alberto; Salinas, Rodrigo; Hevia, Adriana; Bota, Alexandre; Feinholz, Dafna; Fuchs, Michael; Schramm, Roland; Tealdi, Juan-Carlos; Zorrilla, Sergio

    2010-12-01

    The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining 'ethics regulation system for biomedical research' as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities.

  12. Task types and error types involved in the human-related unplanned reactor trip events

    International Nuclear Information System (INIS)

    Kim, Jae Whan; Park, Jin Kyun

    2008-01-01

    In this paper, the contribution of task types and error types involved in the human-related unplanned reactor trip events that have occurred between 1986 and 2006 in Korean nuclear power plants are analysed in order to establish a strategy for reducing the human-related unplanned reactor trips. Classification systems for the task types, error modes, and cognitive functions are developed or adopted from the currently available taxonomies, and the relevant information is extracted from the event reports or judged on the basis of an event description. According to the analyses from this study, the contributions of the task types are as follows: corrective maintenance (25.7%), planned maintenance (22.8%), planned operation (19.8%), periodic preventive maintenance (14.9%), response to a transient (9.9%), and design/manufacturing/installation (6.9%). According to the analysis of the error modes, error modes such as control failure (22.2%), wrong object (18.5%), omission (14.8%), wrong action (11.1%), and inadequate (8.3%) take up about 75% of the total unplanned trip events. The analysis of the cognitive functions involved in the events indicated that the planning function had the highest contribution (46.7%) to the human actions leading to unplanned reactor trips. This analysis concludes that in order to significantly reduce human-induced or human-related unplanned reactor trips, an aide system (in support of maintenance personnel) for evaluating possible (negative) impacts of planned actions or erroneous actions as well as an appropriate human error prediction technique, should be developed

  13. Task types and error types involved in the human-related unplanned reactor trip events

    Energy Technology Data Exchange (ETDEWEB)

    Kim, Jae Whan; Park, Jin Kyun [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2008-12-15

    In this paper, the contribution of task types and error types involved in the human-related unplanned reactor trip events that have occurred between 1986 and 2006 in Korean nuclear power plants are analysed in order to establish a strategy for reducing the human-related unplanned reactor trips. Classification systems for the task types, error modes, and cognitive functions are developed or adopted from the currently available taxonomies, and the relevant information is extracted from the event reports or judged on the basis of an event description. According to the analyses from this study, the contributions of the task types are as follows: corrective maintenance (25.7%), planned maintenance (22.8%), planned operation (19.8%), periodic preventive maintenance (14.9%), response to a transient (9.9%), and design/manufacturing/installation (6.9%). According to the analysis of the error modes, error modes such as control failure (22.2%), wrong object (18.5%), omission (14.8%), wrong action (11.1%), and inadequate (8.3%) take up about 75% of the total unplanned trip events. The analysis of the cognitive functions involved in the events indicated that the planning function had the highest contribution (46.7%) to the human actions leading to unplanned reactor trips. This analysis concludes that in order to significantly reduce human-induced or human-related unplanned reactor trips, an aide system (in support of maintenance personnel) for evaluating possible (negative) impacts of planned actions or erroneous actions as well as an appropriate human error prediction technique, should be developed.

  14. Performing piety in sexual health research: gender, health and evangelical Christianities in a Mexican human papillomavirus (HPV) study.

    Science.gov (United States)

    Wentzell, Emily

    2017-12-01

    Recent research suggests that health surveillance experiences like clinical trial participation might have unanticipated social consequences. I investigate how evangelical Christians participating in longitudinal, observational sexual health research incorporate that long-term medical surveillance into their religious practice. This exploratory research focuses on Mexican Cristianos' participation in the Cuernavaca arm of the multinational 'Human Papillomavirus in Men' ('HIM') study, which tested men for the common and usually asymptomatic sexually transmitted infection human papillomavirus (HPV) over time. I draw on interviews with heterosexual male research participants and their female partners throughout their medical research involvement, and data from church-based participant observation, to understand how couples framed the HIM study as an arena for performing piety. I argue that evangelical understandings of piety as moral practice encouraged participants to view long-term sexual health surveillance as assistance for living out the health, gender, and marital behaviors promoted by their congregations. This finding suggests that health research designers and ethics committees should consider the health and social outcomes of research participants' agentive incorporation of religious observance into study protocols.

  15. The Self-Organization of Human Interaction

    DEFF Research Database (Denmark)

    Dale, Rick; Fusaroli, Riccardo; Duran, Nicholas

    2013-01-01

    We describe a “centipede’s dilemma” that faces the sciences of human interaction. Research on human interaction has been involved in extensive theoretical debate, although the vast majority of research tends to focus on a small set of human behaviors, cognitive processes, and interactive contexts...

  16. 77 FR 2304 - National Human Genome Research Institute; Notice of Meeting

    Science.gov (United States)

    2012-01-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome....S.C. 281(d)(4)), notice is hereby given that the National Human Genome Research Institute (NHGRI... meeting of the National Advisory Council for Human Genome Research. Background materials on the proposed...

  17. Human Securitability: A Participatory Action Research Study Involving Novice Teachers and Youngsters

    Science.gov (United States)

    Kravale-Paulina, Marite; Olehnovica, Eridiana

    2015-01-01

    Civic participation, initiative and interest in current events can bridge the alienation felt towards national and municipal institutions, thereby enabling individuals to improve their quality of life and contribute to all-round sustainable development of their resident state. This paper reports on a participatory action research study into civic…

  18. The landscape of human genes involved in the immune response to parasitic worms

    Directory of Open Access Journals (Sweden)

    Fumagalli Matteo

    2010-08-01

    Full Text Available Abstract Background More than 2 billion individuals worldwide suffer from helminth infections. The highest parasite burdens occur in children and helminth infection during pregnancy is a risk factor for preterm delivery and reduced birth weight. Therefore, helminth infections can be regarded as a strong selective pressure. Results Here we propose that candidate susceptibility genes for parasitic worm infections can be identified by searching for SNPs that display a strong correlation with the diversity of helminth species/genera transmitted in different geographic areas. By a genome-wide search we identified 3478 variants that correlate with helminth diversity. These SNPs map to 810 distinct human genes including loci involved in regulatory T cell function and in macrophage activation, as well as leukocyte integrins and co-inhibitory molecules. Analysis of functional relationships among these genes identified complex interaction networks centred around Th2 cytokines. Finally, several genes carrying candidate targets for helminth-driven selective pressure also harbour susceptibility alleles for asthma/allergy or are involved in airway hyper-responsiveness, therefore expanding the known parallelism between these conditions and parasitic infections. Conclusions Our data provide a landscape of human genes that modulate susceptibility to helminths and indicate parasitic worms as one of the major selective forces in humans.

  19. Cellular processes involved in human epidermal cells exposed to extremely low frequency electric fields.

    Science.gov (United States)

    Collard, J-F; Hinsenkamp, M

    2015-05-01

    We observed on different tissues and organisms a biological response after exposure to pulsed low frequency and low amplitude electric or electromagnetic fields but the precise mechanism of cell response remains unknown. The aim of this publication is to understand, using bioinformatics, the biological relevance of processes involved in the modification of gene expression. The list of genes analyzed was obtained after microarray protocol realized on cultures of human epidermal explants growing on deepidermized human skin exposed to a pulsed low frequency electric field. The directed acyclic graph on a WebGestalt Gene Ontology module shows six categories under the biological process root: "biological regulation", "cellular process", "cell proliferation", "death", "metabolic process" and "response to stimulus". Enriched derived categories are coherent with the type of in vitro culture, the stimulation protocol or with the previous results showing a decrease of cell proliferation and an increase of differentiation. The Kegg module on WebGestalt has highlighted "cell cycle" and "p53 signaling pathway" as significantly involved. The Kegg website brings out interactions between FoxO, MAPK, JNK, p53, p38, PI3K/Akt, Wnt, mTor or NF-KappaB. Some genes expressed by the stimulation are known to have an exclusive function on these pathways. Analyses performed with Pathway Studio linked cell proliferation, cell differentiation, apoptosis, cell cycle, mitosis, cell death etc. with our microarrays results. Medline citation generated by the software and the fold change variation confirms a diminution of the proliferation, activation of the differentiation and a less well-defined role of apoptosis or wound healing. Wnt and DKK functional classes, DKK1, MACF1, ATF3, MME, TXNRD1, and BMP-2 genes proposed in previous publications after a manual analysis are also highlighted with other genes after Pathway Studio automatic procedure. Finally, an analysis conducted on a list of genes

  20. Research opportunities in human behavior and performance

    Science.gov (United States)

    Christensen, J. M. (Editor); Talbot, J. M. (Editor)

    1985-01-01

    Extant information on the subject of psychological aspects of manned space flight are reviewed; NASA's psychology research program is examined; significant gaps in knowledge are identified; and suggestions are offered for future research program planning. Issues of human behavior and performance related to the United States space station, to the space shuttle program, and to both near and long term problems of a generic nature in applicable disciplines of psychology are considered. Topics covered include: (1) human performance requirements for a 90 day mission; (2) human perceptual, cognitive, and motor capabilities and limitations in space; (3) crew composition, individual competencies, crew competencies, selection criteria, and special training; (4) environmental factors influencing behavior; (5) psychosocial aspects of multiperson space crews in long term missions; (6) career determinants in NASA; (7) investigational methodology and equipment; and (8) psychological support.

  1. Clinical research data sharing: what an open science world means for researchers involved in evidence synthesis.

    Science.gov (United States)

    Ross, Joseph S

    2016-09-20

    The International Committee of Medical Journal Editors (ICMJE) recently announced a bold step forward to require data generated by interventional clinical trials that are published in its member journals to be responsibly shared with external investigators. The movement toward a clinical research culture that supports data sharing has important implications for the design, conduct, and reporting of systematic reviews and meta-analyses. While data sharing is likely to enhance the science of evidence synthesis, facilitating the identification and inclusion of all relevant research, it will also pose key challenges, such as requiring broader search strategies and more thorough scrutiny of identified research. Furthermore, the adoption of data sharing initiatives by the clinical research community should challenge the community of researchers involved in evidence synthesis to follow suit, including the widespread adoption of systematic review registration, results reporting, and data sharing, to promote transparency and enhance the integrity of the research process.

  2. Human Research Program: 2012 Fiscal Year Annual Report

    Science.gov (United States)

    Effenhauser, Laura

    2012-01-01

    Crew health and performance are critical to successful human exploration beyond low Earth orbit. Risks to health and performance include physiologic effects from radiation, hypogravity, and planetary environments, as well as unique challenges in medical treatment, human factors, and support of behavioral health. The scientists and engineers of the Human Research Program (HRP) investigate and reduce the greatest risks to human health and performance, and provide essential countermeasures and technologies for human space exploration. In its seventh year of operation, the HRP continued to refine its management architecture of evidence, risks, gaps, tasks, and deliverables. Experiments continued on the International Space Station (ISS), on the ground in analog environments that have features similar to those of spaceflight, and in laboratory environments. Data from these experiments furthered the understanding of how the space environment affects the human system. These research results contributed to scientific knowledge and technology developments that address the human health and performance risks. As shown in this report, HRP has made significant progress toward developing medical care and countermeasure systems for space exploration missions which will ultimately reduce risks to crew health and performance.

  3. Being useful: achieving indigenous youth involvement in a community-based participatory research project in Alaska

    Directory of Open Access Journals (Sweden)

    Tara Ford

    2012-05-01

    Full Text Available Objectives. To report on a participatory research process in southwest Alaska focusing on youth involvement as a means to facilitate health promotion. We propose youth-guided community-based participatory research (CBPR as way to involve young people in health promotion and prevention strategizing as part of translational science practice at the community-level. Study design. We utilized a CBPR approach that allowed youth to contribute at all stages. Methods. Implementation of the CBPR approach involved the advancement of three key strategies including: (a the local steering committee made up of youth, tribal leaders, and elders, (b youth-researcher partnerships, and (c youth action-groups to translate findings. Results. The addition of a local youth-action and translation group to the CBPR process in the southwest Alaska site represents an innovative strategy for disseminating findings to youth from a research project that focuses on youth resilience and wellbeing. This strategy drew from two community-based action activities: (a being useful by helping elders and (b being proud of our village. Conclusions. In our study, youth informed the research process at every stage, but most significantly youth guided the translation and application of the research findings at the community level. Findings from the research project were translated by youth into serviceable action in the community where they live. The research created an experience for youth to spend time engaged in activities that, from their perspectives, are important and contribute to their wellbeing and healthy living. Youth-guided CBPR meant involving youth in the process of not only understanding the research process but living through it as well.

  4. 34 CFR 75.681 - Protection of human research subjects.

    Science.gov (United States)

    2010-07-01

    ... Conditions Must Be Met by a Grantee? Other Requirements for Certain Projects § 75.681 Protection of human research subjects. If a grantee uses a human subject in a research project, the grantee shall protect the person from physical, psychological, or social injury resulting from the project. (Authority: 20 U.S.C...

  5. Evolution of External Consultant Involvement in Human Resource Management in Eastern Europe (1990-2007

    Directory of Open Access Journals (Sweden)

    József Poór

    2015-03-01

    Full Text Available This paper aims to analyze the evolution of Human Resources (HR consulting in transitional economies of Eastern Europe (EE from the political changes till the economic crisis (2008. This article provides insights into the specific socio-economic environment and HR practice of the region.  Following Markham's model (1999 we analyze specific characteristics of four typical ways of external consultant involvement: informative-becnhmarking, design, change and organizational learning consulting.  in this region. In general, before the political changes at the end of the 1980's, in most EE countries , consulting service was redendered by sector  research institutes, controlled by the state or by the different minsitries. Consulting approach in EE countries  were predominant similar to the school of scientific management. HR consulting hardly existed that time. Since changes in the regime's consulting linked to privatization, firm restructuring, and development has been developing significantly in all countries of the region. HR consulting underwent a significant development in the region.

  6. The concept of human dignity in the ethics of genetic research.

    Science.gov (United States)

    Chan, David K

    2015-05-01

    Despite criticism that dignity is a vague and slippery concept, a number of international guidelines on bioethics have cautioned against research that is contrary to human dignity, with reference specifically to genetic technology. What is the connection between genetic research and human dignity? In this article, I investigate the concept of human dignity in its various historical forms, and examine its status as a moral concept. Unlike Kant's ideal concept of human dignity, the empirical or relational concept takes human dignity as something that is affected by one's circumstances and what others do. I argue that the dignity objection to some forms of genetic research rests on a view of human nature that gives humans a special status in nature - one that is threatened by the potential of genetic research to reduce individuals to their genetic endowment. I distinguish two main philosophical accounts of human nature. One of these, the Aristotelian view, is compatible with the use of genetic technology to help humans realize their inherent potential to a fuller extent. © 2014 John Wiley & Sons Ltd.

  7. Characterization of Staphylococcus aureus strains involved in human and bovine mastitis.

    Science.gov (United States)

    Delgado, Susana; García, Pilar; Fernández, Leonides; Jiménez, Esther; Rodríguez-Baños, Mercedes; del Campo, Rosa; Rodríguez, Juan M

    2011-07-01

    Staphylococcus aureus is one of the main etiological agents of mastitis in different mammalian species. At present, it is unknown whether strains isolated from human mastitis cases share phenotypic properties and genetic background with those obtained from animal mastitis cases. Therefore, the objective of this study was to characterize S. aureus strains isolated from women with lactational mastitis and to compare them with the strains responsible for bovine mastitis and noninfectious strains. All the strains were genotyped by both pulsed field gel electrophoresis and multilocus sequence typing and submitted to a characterization scheme that included diverse assays related to pathogenic potential and antibiotic resistance. Apart from siderophore production, no significant association was observed between the strains from bovine and human mastitis. Statistical differences between human- and bovine-mastitis-associated strains were detected for some traits and virulence determinants, such as the presence of prophages and cna and hlb genes, which were more frequently found within the bovine group. On the contrary, resistance to penicillin was significantly higher among strains isolated from human lactational mastitis, probably related to the common presence of the blaZ gene. A high genetic diversity was found among the strains involved in mastitis in breastfeeding women. © 2011 Federation of European Microbiological Societies. Published by Blackwell Publishing Ltd. All rights reserved.

  8. Information Presentation: Human Research Program - Space Human Factors and Habitability, Space Human Factors Engineering Project

    Science.gov (United States)

    Holden, Kristina L.; Sandor, Aniko; Thompson, Shelby G.; Kaiser, Mary K.; McCann, Robert S.; Begault, D. R.; Adelstein, B. D.; Beutter, B. R.; Wenzel, E. M.; Godfroy, M.; hide

    2010-01-01

    The goal of the Information Presentation Directed Research Project (DRP) is to address design questions related to the presentation of information to the crew. The major areas of work, or subtasks, within this DRP are: 1) Displays, 2) Controls, 3) Electronic Procedures and Fault Management, and 4) Human Performance Modeling. This DRP is a collaborative effort between researchers atJohnson Space Center and Ames Research Center. T

  9. Human needs as predictors for organizational commitment and job involvement: An exploratory empirical study

    OpenAIRE

    Park, Yang-Kyu; Lee, Chul-in; Kabst, Rüdiger

    2008-01-01

    While the literature on the determinants of organizational commitment (OC) and job involvement (JI) is vast, little has been studied about the impact of human needs. In search for the institutional stars, this study examines whether human needs can serve a predictor for both high OC and high JI. Exploratory empirical results based on quantile regressions suggest that the needs for achievement, belonging, and power are more important than others in predicting OC and JI. In addition, the basic ...

  10. Human Research Program Human Health Countermeasures Element: Evidence Report - Artificial Gravity

    Science.gov (United States)

    Clement, Gilles

    2015-01-01

    The most serious risks of long-duration flight involve radiation, behavioral stresses, and physiological deconditioning. Artificial gravity (AG), by substituting for the missing gravitational cues and loading in space, has the potential to mitigate the last of these risks by preventing the adaptive responses from occurring. The rotation of a Mars-bound spacecraft or an embarked human centrifuge offers significant promise as an effective, efficient multi-system countermeasure against the physiological deconditioning associated with prolonged weightlessness. Virtually all of the identified risks associated with bone loss, muscle weakening, cardiovascular deconditioning, and sensorimotor disturbances might be alleviated by the appropriate application of AG. However, experience with AG in space has been limited and a human-rated centrifuge is currently not available on board the ISS. A complete R&D program aimed at determining the requirements for gravity level, gravity gradient, rotation rate, frequency, and duration of AG exposure is warranted before making a decision for implementing AG in a human spacecraft.

  11. People involved in radiation research and protection - an historical perspective

    International Nuclear Information System (INIS)

    Toussaint, L.F.

    2010-01-01

    Full text: The lives of selected people involved in radiation research are covered in two parts: 1. history of radiation and radioactivity; and 2. historical aspects of radiation and radiation protection in Western Australia. History of radiation/radioactivity: The background of some of the key people involved in early radiation research is discussed. These include Rontgen and Becqucrel who undertook early research into X-rays and radioactivity respectively. As well as the radiation hazards which early radiation scientists faced, there were also social pressures, as exemplified by the life of women such as Marie Curie, particularly after the death of her husband Pierre. Despite this being the time of the so-called 'beautiful years' in Europe, where there was a friendly exchange of ideas between scientists from various countries, there were also protracted disagreements. Some of the scientific findings of the Curies' daughter (Irene Joliot-Curie) and husband (Frederic Joliot-Curie) were vigorously disputed by Lisa Meitner (and colleague Otto Hahn) in Vienna. The 'beautiful years' came to an end when politics intruded and scientists such as Lisa Meitner had to flee from persecution. The splitting of the atom and realisation (by Leo Szilard) that a chain reaction was possible, led to political barriers being erected around scientists. With Europe poised for war, the implication of this science for warfare application was cause for concern among many of the normally free thinking and co-operative scientists. Secrecy now prevailed.

  12. Hans Jonas' thought on the ethics of research on human subjects ...

    African Journals Online (AJOL)

    Hans Jonas' thought on the ethics of research on human subjects and its implications for contemporary medical research in Nigeria was examined. The thinking and teachings of Hans Jonas was on the need for medical research to advance beyond the use animals for research and experimentations to research on human ...

  13. Ethnographic research with adolescent students: situated fieldwork ethics and ethical principles governing human research.

    Science.gov (United States)

    Hemmings, Annette

    2009-12-01

    This paper explores ethical dilemmas in situated fieldwork ethics concerning ethnographic studies of adolescent students. While consequentialist and deontological ethics form the basis of the ethical stances shared by ethnographers and research ethics committees, the interpretation of those principles may diverge in school-based ethnography with adolescent students because of the particular role of the adult ethnographer vis-à-vis developmentally immature adolescents not held legally responsible for many of their actions. School ethnographers attempt to build trust with adolescent participants in order to learn about their hidden cultural worlds, which may involve activities that are very harmful to the youths involved. They face many difficult and sometimes unexpected choices, including whether to intervene and how to represent events and adolescents in published findings. Scenarios with examples drawn from research conducted in public high schools are used to illustrate and explicate dilemmas in formal research and latent insider/outsider roles and relations involving harmful adolescent behaviors, advocacy, and psychological trauma. Also examined are analytical procedures used to construct interpretations leading to representations of research participants in the resulting publication.

  14. Biomedical research involving patients with disorders of consciousness: ethical and legal dimensions

    Directory of Open Access Journals (Sweden)

    Michele Farisco

    2014-09-01

    Full Text Available The directive 2001/20/UE and the research involving patients with docs. Research involving patients with disorders of consciousness (DOCs deserves special ethical and legal attention because of its Janus-faced nature. On the one hand, it raises concerns about the risk to expose the involved subjects to disproportionate risks not respecting their individual dignity, particularly their right to be cared for; on the other hand, research is an essential tool in order to improve the clinical condition of patients with DOCs. The present paper concerns the ethical and legal dimensions of biomedical research involving patients with disorders of consciousness. In particular, it focuses on informed consent to experimental treatments, which is a challenging issue both from an ethical and legal point of view. The first part reads the Directive 2001/20/EU in the light of the experimentation of patients with DOCs, and suggests a revision in order to better assess the issue of informed consent. The particular case of informed consent for observational studies of non-communicative patients. The second part presents an informed consent form for studies through video-recording of patients unable to communicate their own consent. This form has been elaborated by the bioethics unit of the project "Review of the nosography of vegetative states: application of methods of behavioral analysis to individuals in coma or vegetative state" developed at the Italian National Institute of Health. Relevance of the suggested form. The paper describes the conceptual framework of the form for informed consent to studies through video-recoding, which is a relevant example of what issues should be included in an informed consent for any type of studies through video-recording of patients unable to express their own consent. The article has been sent on November the 7th 2013, before the adoption of the Regulation (EU no. 536/2014 (and consequent abrogation of the Directive 2001

  15. Human-Computer Interaction and Information Management Research Needs

    Data.gov (United States)

    Networking and Information Technology Research and Development, Executive Office of the President — In a visionary future, Human-Computer Interaction HCI and Information Management IM have the potential to enable humans to better manage their lives through the use...

  16. A devolved model for public involvement in the field of mental health research: case study learning.

    Science.gov (United States)

    Moule, Pam; Davies, Rosie

    2016-12-01

    Patient and public involvement in all aspects of research is espoused and there is a continued interest in understanding its wider impact. Existing investigations have identified both beneficial outcomes and remaining issues. This paper presents the impact of public involvement in one case study led by a mental health charity conducted as part of a larger research project. The case study used a devolved model of working, contracting with service user-led organizations to maximize the benefits of local knowledge on the implementation of personalized budgets, support recruitment and local user-led organizations. To understand the processes and impact of public involvement in a devolved model of working with user-led organizations. Multiple data collection methods were employed throughout 2012. These included interviews with the researchers (n = 10) and research partners (n = 5), observation of two case study meetings and the review of key case study documentation. Analysis was conducted in NVivo10 using a coding framework developed following a literature review. Five key themes emerged from the data; Devolved model, Nature of involvement, Enabling factors, Implementation challenges and Impact. While there were some challenges of implementing the devolved model it is clear that our findings add to the growing understanding of the positive benefits research partners can bring to complex research. A devolved model can support the involvement of user-led organizations in research if there is a clear understanding of the underpinning philosophy and support mechanisms are in place. © 2015 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

  17. Patient involvement in a scientific advisory process: setting the research agenda for medical products.

    NARCIS (Netherlands)

    Elberse, J.E.; Pittens, C.A.C.M.; de Cock Buning, J.T.; Broerse, J.E.W.

    2012-01-01

    Patient involvement in scientific advisory processes could lead to more societally relevant advice. This article describes a case study wherein the Health Council of the Netherlands involved patient groups in an advisory process with a predefined focus: setting a research agenda for medical products

  18. Human tissue models in cancer research: looking beyond the mouse

    Directory of Open Access Journals (Sweden)

    Samuel J. Jackson

    2017-08-01

    Full Text Available Mouse models, including patient-derived xenograft mice, are widely used to address questions in cancer research. However, there are documented flaws in these models that can result in the misrepresentation of human tumour biology and limit the suitability of the model for translational research. A coordinated effort to promote the more widespread development and use of ‘non-animal human tissue’ models could provide a clinically relevant platform for many cancer studies, maximising the opportunities presented by human tissue resources such as biobanks. A number of key factors limit the wide adoption of non-animal human tissue models in cancer research, including deficiencies in the infrastructure and the technical tools required to collect, transport, store and maintain human tissue for lab use. Another obstacle is the long-standing cultural reliance on animal models, which can make researchers resistant to change, often because of concerns about historical data compatibility and losing ground in a competitive environment while new approaches are embedded in lab practice. There are a wide range of initiatives that aim to address these issues by facilitating data sharing and promoting collaborations between organisations and researchers who work with human tissue. The importance of coordinating biobanks and introducing quality standards is gaining momentum. There is an exciting opportunity to transform cancer drug discovery by optimising the use of human tissue and reducing the reliance on potentially less predictive animal models.

  19. Human tissue models in cancer research: looking beyond the mouse.

    Science.gov (United States)

    Jackson, Samuel J; Thomas, Gareth J

    2017-08-01

    Mouse models, including patient-derived xenograft mice, are widely used to address questions in cancer research. However, there are documented flaws in these models that can result in the misrepresentation of human tumour biology and limit the suitability of the model for translational research. A coordinated effort to promote the more widespread development and use of 'non-animal human tissue' models could provide a clinically relevant platform for many cancer studies, maximising the opportunities presented by human tissue resources such as biobanks. A number of key factors limit the wide adoption of non-animal human tissue models in cancer research, including deficiencies in the infrastructure and the technical tools required to collect, transport, store and maintain human tissue for lab use. Another obstacle is the long-standing cultural reliance on animal models, which can make researchers resistant to change, often because of concerns about historical data compatibility and losing ground in a competitive environment while new approaches are embedded in lab practice. There are a wide range of initiatives that aim to address these issues by facilitating data sharing and promoting collaborations between organisations and researchers who work with human tissue. The importance of coordinating biobanks and introducing quality standards is gaining momentum. There is an exciting opportunity to transform cancer drug discovery by optimising the use of human tissue and reducing the reliance on potentially less predictive animal models. © 2017. Published by The Company of Biologists Ltd.

  20. Japan. Human cloning ban allows some research.

    Science.gov (United States)

    Normile, D

    2000-12-08

    TOKYO--Japanese legislators last week approved a ban on human cloning that leaves room for the use of certain techniques in basic research. The action comes at the same time officials in two other countries--China and France--aired similar proposals that would prohibit so-called reproductive cloning while recognizing the possible importance of the technology in combating disease and improving human health.

  1. Increasing User Involvement in Health Care and Health Research Simultaneously

    DEFF Research Database (Denmark)

    Kaltoft, Mette Kjer; Nielsen, Jesper Bo; Salkeld, Glenn

    2014-01-01

    of the effects of different actions and interventions on their health, including those implying contact with health care services. We see their research as primarily carried out in order to make better decisions for themselves, but they can offer to contribute the results to the wider population. We see...... at the point of decision need, when motivation is highest. Some basic distinctions, such as those between science and non-science, research and practice, community and individual, and lay and professional become somewhat blurred and may need to be rethought in light of this approach....... to increased user involvement, though somewhat more aligned with the former. METHODS: Our online decision support tools, delivered directly to the person in the community and openly accessible, are to be seen as research resources. They will take the form of interactive decision aids for a variety of specific...

  2. Active patient involvement in the education of health professionals.

    Science.gov (United States)

    Towle, Angela; Bainbridge, Lesley; Godolphin, William; Katz, Arlene; Kline, Cathy; Lown, Beth; Madularu, Ioana; Solomon, Patricia; Thistlethwaite, Jill

    2010-01-01

    Patients as educators (teaching intimate physical examination) first appeared in the 1960s. Since then, rationales for the active involvement of patients as educators have been well articulated. There is great potential to promote the learning of patient-centred practice, interprofessional collaboration, community involvement, shared decision making and how to support self-care. We reviewed and summarised the literature on active patient involvement in health professional education. A synthesis of the literature reveals increasing diversity in the ways in which patients are involved in education, but also the movement's weaknesses. Most initiatives are 'one-off' events and are reported as basic descriptions. There is little rigorous research or theory of practice or investigation of behavioural outcomes. The literature is scattered and uses terms (such as 'patient'!) that are contentious and confusing. We propose future directions for research and development, including a taxonomy to facilitate dialogue, an outline of a research strategy and reference to a comprehensive bibliography covering all health and human services.

  3. Medical staff involvement in nursing homes: development of a conceptual model and research agenda.

    Science.gov (United States)

    Shield, Renée; Rosenthal, Marsha; Wetle, Terrie; Tyler, Denise; Clark, Melissa; Intrator, Orna

    2014-02-01

    Medical staff (physicians, nurse practitioners, physicians' assistants) involvement in nursing homes (NH) is limited by professional guidelines, government policies, regulations, and reimbursements, creating bureaucratic burden. The conceptual NH Medical Staff Involvement Model, based on our mixed-methods research, applies the Donabedian "structure-process-outcomes" framework to the NH, identifying measures for a coordinated research agenda. Quantitative surveys and qualitative interviews conducted with medical directors, administrators and directors of nursing, other experts, residents and family members and Minimum Data Set, the Online Certification and Reporting System and Medicare Part B claims data related to NH structure, process, and outcomes were analyzed. NH control of medical staff, or structure, affects medical staff involvement in care processes and is associated with better outcomes (e.g., symptom management, appropriate transitions, satisfaction). The model identifies measures clarifying the impact of NH medical staff involvement on care processes and resident outcomes and has strong potential to inform regulatory policies.

  4. Preliminary thoughts on research in medical humanities.

    Science.gov (United States)

    Yun, Xiaojing; Guo, Jiawei; Qian, Haihong

    2017-05-23

    Medical humanities (MH) is an interdisciplinary field of medicine which includes the humanities (literature, philosophy, ethics, history, and religion), social sciences (anthropology, cultural studies, psychology, sociology, and health geography), and the arts (literature, theater, film, and visual arts) and their application to medical education and practice. Studies of MH should not be limited to theoretical discussions. Research results must be translated into use of methodologies to formulate medical policies, guide clinical practices, and help resolve physical or mental problems. MH has a critical role in addressing medicine-related issues, such as human cloning legislation and the treatment of Ebola virus infection. Recently, MH has also been included in the "Healthy China 2030" project, indicating that MH has garnered more attention in China. Medical colleges, research institutes, and non-profit organizations are focusing on MH studies. Over the past few years, financial support for MH studies has also increased. Although the development of MH currently lags behind medicine and health sciences, MH has promise.

  5. 77 FR 59933 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-10-01

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

  6. 76 FR 29772 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-05-23

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

  7. Human genetics studies in areas of high natural radiation. IV. Research in radioactive areas

    Energy Technology Data Exchange (ETDEWEB)

    Freire-Maia, A [Faculdade de Ciencias Medicas e Biologicas de Botucatu (Brazil). Departamento de Genetica

    1974-01-01

    A review is made on researches performed in areas with high levels of natural radioactivity. Some considerations are made on the importance and difficulties involved in projects of this kind. Although there is no doubt that natural radioactivity is one of the causes of the so-called spontaneous mutations, the practical demonstration of this assertion is extremely complex. Projects trying to correlate high levels of natural radioactivity with the occurrence of cancer (in general, or specific), leukemia, congenital malformations (in general or specific), neuro-vegetative disturbs, sex ratio, mortality, and physical development, as well as other characteristics. Some researches with animals are also mentioned, and references are given for plant studies. A critical analysis is made of some works relating to human populations.

  8. Human genetics studies in areas of high natural radiation.IV. Research in radioactive areas

    International Nuclear Information System (INIS)

    Freire-Maia, A.

    1974-01-01

    A review is made on researches performed in areas with high levels of natural radioactivity. Some considerations are made on the importance and difficulties involved in projects of this kind. Although there is no doubt that natural radioactivity is one of the causes of the so-called spontaneous mutations, the practical demonstration of this assertion is extremely complex. Projects trying to correlate high levels of natural radioactivity with the occurrence of cancer (in general, or specific), leukemia, congenital malformations (in general or specific), neuro-vegetative disturbs, sex ratio, mortality, and physical development, as well as other characteristics. Some researches with animals are also mentioned, and references are given for plant studies. A critical analysis is made of some works relating to human populations [pt

  9. Mercury toxicokinetics of the healthy human term placenta involve amino acid transporters and ABC transporters

    International Nuclear Information System (INIS)

    Straka, Elisabeth; Ellinger, Isabella; Balthasar, Christina; Scheinast, Matthias; Schatz, Jasmin; Szattler, Tamara; Bleichert, Sonja; Saleh, Leila; Knöfler, Martin; Zeisler, Harald; Hengstschläger, Markus; Rosner, Margit; Salzer, Hans; Gundacker, Claudia

    2016-01-01

    Highlights: • It is known that MeHg is able to pass the placenta and to affect fetal brain development. • Uptake and efflux transporters were examined in human primary trophoblast cells and BeWo cells. • Involvement in mercury transfer was assessed by measurement of cellular mercury content upon siRNA mediated gene knockdown. • Localization of transporters was determined by immunofluorescence microscopy. • LAT1 and rBAT at the apical membrane of the syncytiotrophoblast (STB) are involved in MeHg uptake. • MRP1 located at basal membrane of STB mediates mercury efflux. - Abstract: Background: The capacity of the human placenta to handle exogenous stressors is poorly understood. The heavy metal mercury is well-known to pass the placenta and to affect brain development. An active transport across the placenta has been assumed. The underlying mechanisms however are virtually unknown. Objectives: Uptake and efflux transporters (17 candidate proteins) assumed to play a key role in placental mercury transfer were examined for expression, localization and function in human primary trophoblast cells and the trophoblast-derived choriocarcinoma cell line BeWo. Methods: To prove involvement of the transporters, we used small interfering RNA (siRNA) and exposed cells to methylmercury (MeHg). Total mercury contents of cells were analyzed by Cold vapor-atomic fluorescence spectrometry (CV-AFS). Localization of the proteins in human term placenta sections was determined via immunofluorescence microscopy. Results: We found the amino acid transporter subunits L-type amino acid transporter (LAT)1 and rBAT (related to b 0,+ type amino acid transporter) as well as the efflux transporter multidrug resistance associated protein (MRP)1 to be involved in mercury kinetics of trophoblast cells (t-test P < 0.05). Conclusion: The amino acid transporters located at the apical side of the syncytiotrophoblast (STB) manage uptake of MeHg. Mercury conjugated to glutathione (GSH) is

  10. 77 FR 5035 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-02-01

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

  11. 77 FR 58402 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-09-20

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

  12. 78 FR 55752 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-09-11

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

  13. 78 FR 56905 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-09-16

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

  14. 78 FR 107 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-01-02

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

  15. 76 FR 44512 - Human Subjects Research Protections: Enhancing Protections for Research Subjects and Reducing...

    Science.gov (United States)

    2011-07-26

    ... regulatory requirements that can apply to a single research study have been criticized as complex... research studies, as follows: 1. The highest level of review, applied to most studies involving more than... long-range effects of applying knowledge gained in the research (for example, the possible effects of...

  16. 75 FR 8374 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-02-24

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

  17. 78 FR 64222 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-10-28

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

  18. 77 FR 60706 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-04

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

  19. 77 FR 20646 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-04-05

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

  20. 78 FR 21382 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... applications. Place: National Human Genome Research Institute, Suite 4076, 5635 Fisher's Lane, Bethesda, MD..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075...

  1. 78 FR 20933 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-08

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

  2. 76 FR 22112 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-04-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special....nih.gov . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  3. 78 FR 31953 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-05-28

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

  4. 75 FR 10488 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2010-03-08

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research...- 4280, [email protected]gov . Name of Committee: National Human Genome Research Institute Special...

  5. 75 FR 8373 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-02-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute [email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  6. 77 FR 22332 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-04-13

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

  7. 77 FR 8268 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-02-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... applications. Place: National Human Genome Research Institute, 5635 Fisher's Lane, Room 4076, Rockville, MD..., CIDR, National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite...

  8. 75 FR 19984 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2010-04-16

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

  9. 76 FR 28056 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-05-13

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Counselors, National Human Genome Research Institute. The meeting will be closed to the public as indicated... National Human Genome Research Institute, including consideration of personnel qualifications and...

  10. 76 FR 3642 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-01-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research....nih.gov . Name of Committee: National Human Genome Research Institute Special Emphasis Panel eMERGE...

  11. 76 FR 17930 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-03-31

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

  12. 75 FR 52537 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-08-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial....nih.gov . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  13. 76 FR 58023 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-09-19

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

  14. 75 FR 2148 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-01-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial....nih.gov . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  15. 77 FR 28888 - National Human Genome Research Institute Notice of Closed Meeting

    Science.gov (United States)

    2012-05-16

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

  16. 78 FR 70063 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-11-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Counselors, National Human Genome Research Institute. The meeting will be closed to the public as indicated... NATIONAL HUMAN GENOME RESEARCH INSTITUTE, including consideration of personnel qualifications and...

  17. 78 FR 9707 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2013-02-11

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

  18. 77 FR 71604 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-12-03

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

  19. 76 FR 5390 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-01-31

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

  20. 75 FR 13558 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-03-22

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Counselors, National Human Genome Research Institute. The meeting will be closed to the public as indicated... National Human Genome Research Institute, including consideration of personnel qualifications and...

  1. 75 FR 32957 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-06-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... funding cycle. (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  2. 78 FR 14806 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-03-07

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

  3. 75 FR 53703 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-09-01

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

  4. Challenging research on human subjects: justice and uncompensated harms.

    Science.gov (United States)

    Napier, Stephen

    2013-02-01

    Ethical challenges to certain aspects of research on human subjects are not uncommon; examples include challenges to first-in-human trials (Chapman in J Clin Res Bioethics 2(4):1-8, 2011), certain placebo controlled trials (Anderson in J Med Philos 31:65-81, 2006; Anderson and Kimmelman in Kennedy Inst Ethics J 20(1):75-98, 2010) and "sham" surgery (Macklin in N Engl J Med 341:992-996, 1999). To date, however, there are few challenges to research when the subjects are competent and the research is more than minimal risk with no promise of direct benefit. The principal reason given for allowing research that is more than minimal risk without benefit is that we should respect the autonomy of competent subjects. I argue that though the moral intuitions informing respect for autonomy are sound, there is another set of intuitions regarding what we take to be just treatment of another when one agent knowingly causes or allows suffering on another agent. I argue that concerns generated by commutative justice serve as limitations on permissible research. I highlight our intuitions informing this notion of justice by appealing to work done on theodicy; what counts as a morally sufficient reason for God to allow suffering in humans is applicable also to the researcher-subject relationship. I conclude that all human subjects who are exposed to more than minimal risk research should enjoy the same actual protections (e.g., subpart D) as those given subjects who cannot consent.

  5. The prediction of human exposure to substances and radiation. The status of RIVM research

    International Nuclear Information System (INIS)

    Vermeire, T.; Veeren, M. van; Janssen, M.

    1998-03-01

    development and projects to this end are proposed. Analysis of the models also shows that few models have completed all stages of model development from concept to analysis and validation. Many models are still under development and this implies that the data requirements for these models often cannot yet be fulfilled. As regards the overall objective, this report concludes that the RIVM requires a broad, up to date range of instruments for exposure prediction and must be actively involved in all kinds of nationally and internationally relevant networks. The RIVM should also continue to be involved in the development and evaluation of methodology and in discussions concerning harmonisation between sectors. The expertise required is available. Good internal co-ordination is essential. As regards the objectives of this RIVM management project, it was concluded that, in view of the many fruitful discussions which took place between researchers in the laboratories of sectors 2, 4 and 5, an important aim of this project, i.e. to further internal harmonisation and communication in the area of human exposure prediction, had been achieved. (author)

  6. Measurement of testosterone in human sexuality research: methodological considerations.

    Science.gov (United States)

    van Anders, Sari M; Goldey, Katherine L; Bell, Sarah N

    2014-02-01

    Testosterone (T) and other androgens are incorporated into an increasingly wide array of human sexuality research, but there are a number of issues that can affect or confound research outcomes. This review addresses various methodological issues relevant to research design in human studies with T; unaddressed, these issues may introduce unwanted noise, error, or conceptual barriers to interpreting results. Topics covered are (1) social and demographic factors (gender and sex; sexual orientations and sexual diversity; social/familial connections and processes; social location variables), (2) biological rhythms (diurnal variation; seasonality; menstrual cycles; aging and menopause), (3) sample collection, handling, and storage (saliva vs. blood; sialogogues, saliva, and tubes; sampling frequency, timing, and context; shipping samples), (4) health, medical issues, and the body (hormonal contraceptives; medications and nicotine; health conditions and stress; body composition, weight, and exercise), and (5) incorporating multiple hormones. Detailing a comprehensive set of important issues and relevant empirical evidence, this review provides a starting point for best practices in human sexuality research with T and other androgens that may be especially useful for those new to hormone research.

  7. Opening the research agenda for selection of hot spots for human biomonitoring research in Belgium: a participatory research project

    Directory of Open Access Journals (Sweden)

    Chovanova Hana

    2010-07-01

    Full Text Available Abstract Background In order to select priority hotspots for environment and health research in Flanders (Belgium, an open procedure was organized. Environment and health hotspots are strong polluting point sources with possible health effects for residents living in the vicinity of the hot spot. The selection procedure was part of the work of the Flemish Centre of Expertise for Environment and Health, which investigates the relation between environmental pollution and human health. The project is funded and steered by the Flemish government. Methods The involvement of other actors than merely experts is inspired by the 'analytical-deliberative' approach of the National Research Council in the United States and the extended peer community approach. These approaches stress the importance of involving different expert- and social perspectives in order to increase the knowledge base on complex issues. In the procedure used in the project a combination of expert and stakeholder input was essential. The final decision was supported by a multi-criteria analysis of expert assessment and stakeholder advice. Results The endeavour was challenging from the start because of the complicated ambition of including a diversity of actors, potential hotspots, concerns and assessment criteria, but nevertheless the procedure proved its value in both structuring and informing the decision-making process. Moreover the process gained the support of most actors participating in the process, even though the final selection could not satisfy all preferences. Conclusions Opening the research agenda exemplifies the value of inter- and transdisciplinary cooperation as well as the need for a well-structured and negotiated procedure that combines relevant factors and actors with pragmatism. The value of such a process also needs to prove itself in practice after the procedure has been completed: the tension between an ambition of openness on the one hand and a more closed

  8. Involvement of DNA topoisomerase I in transcription of human ribosomal RNA genes

    International Nuclear Information System (INIS)

    Zhang, H.; Wang, J.C.; Liu, L.F.

    1988-01-01

    Treatment of HeLa cells with a DNA topoisomerase I-specific inhibitor, camptothecin, results in rapid cessation of the synthesis of the 45S rRNA precursor. The inhibition of rRNA synthesis is reversible following drug removal and correlates with the presence of camptothecin-trapped topoisomerase I-DNA abortive complexes, which can be detected as topoisomerase I-linked DNA breaks upon lysis with sodium dodecyl sulfate. These breaks were found to be concentrated within the transcribed region of human rRNA genes. No such sites can be detected in the inactive human rRNA genes in mouse-human hybrid cells, suggesting a preferential association of topoisomerase I with actively transcribed genes. The distribution of RNA polymerase molecules along the transcription unit of human rRNA genes in camptothecin-treated HeLa cells, as assayed by nuclear run-on transcription, shows a graded decrease of the RNA polymerase density toward the 3' end of the transcription unit; the density is minimally affected near the 5' start of the transcription unit. These results suggest that DNA topoisomerase I is normally involved in the elongation step of transcription, especially when the transcripts are long, and that camptothecin interferes with this role

  9. 76 FR 19780 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-04-08

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

  10. 76 FR 3917 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-01-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Branch, National Human Genome Research Institute, 5635 Fishers Lane, Suite 4076, MSC 9306, Rockville, MD...

  11. 75 FR 56115 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-09-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS...

  12. 76 FR 3643 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-01-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial... . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

  13. 78 FR 24223 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-04-24

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

  14. 76 FR 35224 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-06-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome...). Contact Person: Camilla E. Day, PhD, Scientific Review Officer, CIR, National Human Genome Research..., [email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  15. 76 FR 22407 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-04-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special.... (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

  16. 75 FR 48977 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-08-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome.... Contact Person: Camilla E. Day, PhD, Scientific Review Officer, CIDR, National Human Genome Research..., [email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  17. 77 FR 74676 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-12-17

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075, Bethesda.... 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: December 11, 2012. David...

  18. 75 FR 26762 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-05-12

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Initial... . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research, National Institutes of...

  19. 75 FR 35821 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-06-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Person: Camilla E. Day, PhD, Scientific Review Officer, CIDR, National Human Genome Research [email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  20. 78 FR 47715 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-08-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Person: Camilla E. Day, Ph.D., Scientific Review Officer, CIDR, National Human Genome Research [email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  1. 77 FR 31863 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-05-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special..., Human Genome Research, National Institutes of Health, HHS) Dated: May 22, 2012. Jennifer S. Spaeth...

  2. 76 FR 79199 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-12-21

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome.... Contact Person: Camilla E. Day, Ph.D., Scientific Review Officer, CIDR, National Human Genome Research..., [email protected] . (Catalogue of Federal Domestic Assistance Program Nos. 93.172, Human Genome Research...

  3. 76 FR 66731 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-10-27

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: October 21, 2011...

  4. 76 FR 10909 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-02-28

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4076, MSC..., Human Genome Research, National Institutes of Health, HHS). Dated: February 18, 2011. Jennifer S. Spaeth...

  5. 76 FR 36930 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-06-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special..., Human Genome Research, National Institutes of Health, HHS) Dated: June 17, 2011. Jennifer S. Spaeth...

  6. 77 FR 35991 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-06-15

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4075, Bethesda.... 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: June 8, 2012. Jennifer S...

  7. 77 FR 61770 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) [[Page 61771...

  8. 76 FR 63932 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-10-14

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: October 7...

  9. 75 FR 8977 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-02-26

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute, National Institutes of Health, 5635 Fishers Lane, Suite 4076, MSC..., Human Genome Research, National Institutes of Health, HHS) Dated: February 18, 2010. Jennifer Spaeth...

  10. 75 FR 67380 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-11-02

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

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

    Science.gov (United States)

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-03-01

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

  12. Intervention Research and Its Influence on Nonintervention Research in Human Resource Development

    Science.gov (United States)

    Park, Sunyoung; Chae, Chungil

    2017-01-01

    Purpose: The purpose of this paper is to identify how intervention research weighed in nonintervention research in the field of human resource development (HRD) by examining the number, citation frequency and use of experimental studies in HRD academic journals. Design/methodology/approach: A total of 2,700 articles published between 1990 and 2014…

  13. Human cortical areas involved in perception of surface glossiness.

    Science.gov (United States)

    Wada, Atsushi; Sakano, Yuichi; Ando, Hiroshi

    2014-09-01

    Glossiness is the visual appearance of an object's surface as defined by its surface reflectance properties. Despite its ecological importance, little is known about the neural substrates underlying its perception. In this study, we performed the first human neuroimaging experiments that directly investigated where the processing of glossiness resides in the visual cortex. First, we investigated the cortical regions that were more activated by observing high glossiness compared with low glossiness, where the effects of simple luminance and luminance contrast were dissociated by controlling the illumination conditions (Experiment 1). As cortical regions that may be related to the processing of glossiness, V2, V3, hV4, VO-1, VO-2, collateral sulcus (CoS), LO-1, and V3A/B were identified, which also showed significant correlation with the perceived level of glossiness. This result is consistent with the recent monkey studies that identified selective neural response to glossiness in the ventral visual pathway, except for V3A/B in the dorsal visual pathway, whose involvement in the processing of glossiness could be specific to the human visual system. Second, we investigated the cortical regions that were modulated by selective attention to glossiness (Experiment 2). The visual areas that showed higher activation to attention to glossiness than that to either form or orientation were identified as right hV4, right VO-2, and right V3A/B, which were commonly identified in Experiment 1. The results indicate that these commonly identified visual areas in the human visual cortex may play important roles in glossiness perception. Copyright © 2014. Published by Elsevier Inc.

  14. Research Ethics

    Science.gov (United States)

    Dooly, Melinda; Moore, Emilee; Vallejo, Claudia

    2017-01-01

    Qualitative research, especially studies in educational contexts, often brings up questions of ethics because the study design involves human subjects, some of whom are under age (e.g. data collected in primary education classrooms). It is not always easy for young researchers to anticipate where ethical issues might emerge while designing their…

  15. Still Human: A Call for Increased Focus on Ethical Standards in Cadaver Research.

    Science.gov (United States)

    Bach, Michelle C

    2016-12-01

    Research on human cadavers is an important mechanism of scientific progress and comprises a large industry in the United States. However, despite its importance and influence, there is little ethical or regulatory oversight of cadaver-based research. This lack of transparency raises important ethical questions. Thus, this paper serves as a call for ethicists and regulators to pay increased attention to cadaver research. I argue that cadaver research ought to be considered a subset of human subjects research and held accountable to higher ethical standards. After describing current practices, I argue that oversight of cadaver research as a form of human subjects research is appropriate because cadaver research is similar to other types of human research, participants in cadaver research incur risks of harm, and a current lack of oversight has allowed the cadaver industry to entice research participation through ethically questionable practices. This paper urges greater dialogue among human subjects research ethicists and regulators about what constitutes appropriate protections for participants in cadaver research.

  16. Are sciences essential and humanities elective? Disentangling competing claims for humanities research public value

    OpenAIRE

    Olmos-Peñuela, Julia; Benneworth, Paul; Castro-Martínez, Elena

    2015-01-01

    Recent policy discourse suggests that arts and humanities research is seen as being less useful to society than other disciplines, notably in science, technology, engineering and mathematics. The paper explores how this assumption s construction has been built and whether it is based upon an unfair prejudice: we argue for a prima facie case to answer in assuming that arts and humanities research s lower societal value. We identify a set of claims circulating in policy circles regarding scienc...

  17. 78 FR 66752 - National Human Genome Research Institute; Amended Notice of Meeting

    Science.gov (United States)

    2013-11-06

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... National Human Genome Research Institute Special Emphasis Panel, October 15, 2013, 01:00 p.m. to October 15, 2013, 02:30 p.m., National Human Genome Research Institute, 5635 Fishers Lane, Suite 3055, Rockville...

  18. Effectiveness of Human Research Protection Program Performance Measurements.

    Science.gov (United States)

    Tsan, Min-Fu; Nguyen, Yen

    2017-10-01

    We analyzed human research protection program performance metric data of all Department of Veterans Affairs research facilities obtained from 2010 to 2016. Among a total of 25 performance metrics, 21 (84%) showed improvement, four (16%) remained unchanged, and none deteriorated during the study period. The overall improvement from these 21 performance metrics was 81.1% ± 18.7% (mean ± SD), with a range of 30% to 100%. The four performance metrics that did not show improvement all had initial noncompliance/incidence rates of performance metrics that showed improvement ranged from 0.05% to 60%. However, of the 21 performance metrics that showed improvement, 10 had initial noncompliance/incidence rates of performance measurement is an effective tool in improving the performance of human research protection programs.

  19. Institutional Oversight of Occupational Health and Safety for Research Programs Involving Biohazards.

    Science.gov (United States)

    Dyson, Melissa C; Carpenter, Calvin B; Colby, Lesley A

    2017-06-01

    Research with hazardous biologic materials (biohazards) is essential to the progress of medicine and science. The field of microbiology has rapidly advanced over the years, partially due to the development of new scientific methods such as recombinant DNA technology, synthetic biology, viral vectors, and the use of genetically modified animals. This research poses a potential risk to personnel as well as the public and the environment. Institutions must have appropriate oversight and take appropriate steps to mitigate the risks of working with these biologic hazards. This article will review responsibilities for institutional oversight of occupational health and safety for research involving biologic hazards.

  20. Data collection using open access technology in multicentre operational research involving patient interviews.

    Science.gov (United States)

    Shewade, H D; Chadha, S S; Gupta, V; Tripathy, J P; Satyanarayana, S; Sagili, K; Mohanty, S; Bera, O P; Pandey, P; Rajeswaran, P; Jayaraman, G; Santhappan, A; Bajpai, U N; Mamatha, A M; Maiser, R; Naqvi, A J; Pandurangan, S; Nath, S; Ghule, V H; Das, A; Prasad, B M; Biswas, M; Singh, G; Mallick, G; Jeyakumar Jaisingh, A J; Rao, R; Kumar, A M V

    2017-03-21

    Conducting multicentre operational research is challenging due to issues related to the logistics of travel, training, supervision, monitoring and troubleshooting support. This is even more burdensome in resource-constrained settings and if the research includes patient interviews. In this article, we describe an innovative model that uses open access tools such as Dropbox, TeamViewer and CamScanner for efficient, quality-assured data collection in an ongoing multicentre operational research study involving record review and patient interviews. The tools used for data collection have been shared for adaptation and use by other researchers.

  1. USING RESEARCH METHODS IN HUMAN COMPUTER INTERACTION TO DESIGN TECHNOLOGY FOR RESILIENCE

    OpenAIRE

    Lopes, Arminda Guerra

    2016-01-01

    ABSTRACT Research in human computer interaction (HCI) covers both technological and human behavioural concerns. As a consequence, the contributions made in HCI research tend to be aware to either engineering or the social sciences. In HCI the purpose of practical research contributions is to reveal unknown insights about human behaviour and its relationship to technology. Practical research methods normally used in HCI include formal experiments, field experiments, field studies, interviews, ...

  2. 77 FR 54584 - Final Action Under the NIH Guidelines for Research Involving Recombinant DNA Molecules (NIH...

    Science.gov (United States)

    2012-09-05

    ... changes. Human gene transfer also raises scientific, medical, social, and ethical considerations that... currently reviewed under Section III-B-1, Experiments Involving the Cloning of Toxin Molecules with LD50 of...

  3. 34 CFR 97.118 - Applications and proposals lacking definite plans for involvement of human subjects.

    Science.gov (United States)

    2010-07-01

    ... Education PROTECTION OF HUMAN SUBJECTS Federal Policy for the Protection of Human Subjects (Basic ED Policy for Protection of Human Research Subjects) § 97.118 Applications and proposals lacking definite plans..., or contracts are submitted to departments or agencies with the knowledge that subjects may be...

  4. Web-based tools for microRNAs involved in human cancer.

    Science.gov (United States)

    Mar-Aguilar, Fermín; Rodríguez-Padilla, Cristina; Reséndez-Pérez, Diana

    2016-06-01

    MicroRNAs (miRNAs/miRs) are a family of small, endogenous and evolutionarily-conserved non-coding RNAs that are involved in the regulation of several cellular and functional processes. miRNAs can act as oncogenes or tumor suppressors in all types of cancer, and could be used as prognostic and diagnostic biomarkers. Databases and computational algorithms are behind the majority of the research performed on miRNAs. These tools assemble and curate the relevant information on miRNAs and present it in a user-friendly manner. The current review presents 14 online databases that address every aspect of miRNA cancer research. Certain databases focus on miRNAs and a particular type of cancer, while others analyze the behavior of miRNAs in different malignancies at the same time. Additional databases allow researchers to search for mutations in miRNAs or their targets, and to review the naming history of a particular miRNA. All these databases are open-access, and are a valuable tool for those researchers working with these molecules, particularly those who lack access to an advanced computational infrastructure.

  5. Research Award: Ecosystems and Human Health (Ecohealth ...

    International Development Research Centre (IDRC) Digital Library (Canada)

    Jean-Claude Dumais

    2012-09-12

    Sep 12, 2012 ... Research Award: Ecosystems and Human Health (Ecohealth) ... Your proposal should demonstrate an understanding of the ... demonstrated ability to work independently, and strong written and oral communications skills are ...

  6. Recent technology products from Space Human Factors research

    Science.gov (United States)

    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.

  7. 75 FR 44800 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-07-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... for Human Genome Research. The meeting will be closed to the public in accordance with the provisions... Committee: National Advisory Council for Human Genome Research. Date: August 18, 2010. Time: 1 p.m. to 3 p.m...

  8. A SHARED study-the benefits and costs of setting up a health research study involving lay co-researchers and how we overcame the challenges.

    Science.gov (United States)

    Mockford, Carole; Murray, Matt; Seers, Kate; Oyebode, Jan; Grant, Richard; Boex, Sue; Staniszewska, Sophie; Diment, Yvonne; Leach, Jim; Sharma, Uma; Clarke, Rosemary; Suleman, Rashida

    2016-01-01

    In the United Kingdom (UK), official bodies such as the Department of Health and research funders such as the National Institute for Health Research support and encourage lay involvement in all stages of research studies. The SHARED study has had substantial patient and public involvement (PPI) from developing the idea to dissemination. The aim of the study has been to develop recommendations led by service users for health and social care professionals to use at hospital discharge and in care planning for people living with memory loss and their carers. This article is about how the study started and the benefits, costs and challenges we encountered as the lead and lay co-researchers. Once we were successful with the grant application, we had to recruit and train the lay co-researchers and obtain various approvals before we could start the project. We had various support from funders, the Research Ethics Committee, lay members of Alzheimer's Society and from the lay co-researchers. However, we encountered some challenges with paying the lay co-researchers and with getting the approval for the co-researchers to interview staff on NHS premises. The challenges were overcome eventually but some aspects of the study changed because of this. We suggest that some changes could be made to the research system which would lead to greater inclusion of the lay co-researchers in research studies and would make the process more straightforward for the research team. Background Involving patients and the public in all stages of research has been the focus of the SHARED study. Patient and public involvement (PPI) is an important strategic priority for the Department of Health and funders such as the National Institute for Health Research. The aim of this paper is to describe the benefits, challenges and costs involved in setting up the research study with lay members as part of the research team. The study focused on developing service user-led recommendations for people with

  9. A role for research ethics committees in exchanges of human biospecimens through material transfer agreements.

    Science.gov (United States)

    Chalmers, Donald; Nicol, Dianne; Nicolás, Pilar; Zeps, Nikolajs

    2014-09-01

    International transfers of human biological material (biospecimens) and data are increasing, and commentators are starting to raise concerns about how donor wishes are protected in such circumstances. These exchanges are generally made under contractual material transfer agreements (MTAs). This paper asks what role, if any, should research ethics committees (RECs) play in ensuring legal and ethical conduct in such exchanges. It is recommended that RECs should play a more active role in the future development of best practice MTAs involving exchange of biospecimens and data and in monitoring compliance.

  10. Human Nutrition Research Conducted at State Agricultural Experiment Stations and 1890/Tuskegee Agricultural Research Programs.

    Science.gov (United States)

    Driskell, Judy A.; Myers, John R.

    1989-01-01

    Cooperative State Research Service-administered and state-appropriated State Agriculture Experiment Station funds for human nutrition research increased about two-fold from FY70-FY86, while the percentage of budget expended for this research decreased. (JOW)

  11. 10 CFR 600.31 - Research misconduct.

    Science.gov (United States)

    2010-01-01

    ... there has been a significant departure from accepted practices of the relevant research community and..., medicine, psychology, social sciences statistics, and research involving human subjects or animals...

  12. Human factors research in Central Research Institute of Electric Power Industry creation of safety culture

    International Nuclear Information System (INIS)

    Horie, Yasuo

    2002-01-01

    To prevent accident of nuclear power plant, Human Factors Center was built in the Central Research Institute of Electric Power Industry in July 1987. It developed an evaluation method of human error cases and an application method of human factors information. Now it continues analysis and application of human factors information, development of training/work support tools and research/experiment of human behavior. Japan-Human Performance Evaluation System (J-HPES) was developed as an analytical system for analysis and evaluation of human factors related to the trouble and for using the result as the common property by storage the analytical results. J-HPES has a standard procedure consisted of collecting and analyzing data and proposing the countermeasures. The analytical results are arranged by 4 kinds of charts by putting into the form of a diagram. Moreover, it tries to find the causes with indirect and potential causes. Two kinds of materials, Caution Report and Human Factors Precept by means of Illustrations, are published. People can gain access to HFC database by URL http://criepi.denken.or.jp/CRIEPI/HFC/DB. To prevent these accidents, creation of human factors culture has been required. Five kinds of teaching materials and the training method are developed. (S.Y.)

  13. Assessing the Influence of Researcher-Partner Involvement on the Process and Outcomes of Participatory Research in Autism Spectrum Disorder and Neurodevelopmental Disorders: A Scoping Review

    Science.gov (United States)

    Jivraj, Jamil; Sacrey, Lori-Ann; Newton, Amanda; Nicholas, David; Zwaigenbaum, Lonnie

    2014-01-01

    Participatory research aims to increase the relevance and broaden the implementation of health research by involving those affected by the outcomes of health studies. Few studies within the field of neurodevelopmental disorders, particularly autism spectrum disorders, have involved autistic individuals as partners. This study sought to identify…

  14. Economic mechanisms of influence on the development of human capital trained in research

    Science.gov (United States)

    Garbuz, V.; Topala, P.

    2017-08-01

    In the XXI century were launched processes that significantly have changed the vector of world economic development and the economy of new type (innovation economy) in which the fundamental role is played by knowledge and “production of knowledge” has turned into a source of new business model and economic growth. The paper explores the premises of creating entrepreneurial universities as part of the triple spiral of knowledge (university-business-state). A special role is given to analysing the impact of research and innovation on the development of human capital because on the long term, education and innovation systems represent the most powerful engines of economic development. Carrying out the applicative analysis allow us to make a contribution to increasing the visibility and international recognition of the research potential of Republic of Moldova, to strengthening the material for the elaboration of comparative studies, to improve the perception on the effectiveness of investment in research and development. The problem of equity-effectiveness ratio and cost-benefit ratio emerges when analysing poignancy forms of research funding (state/private, national/international) because the consequences are profound and longterm with impact on resources and the quality of the human factor. Efficiency refers to the optimal allocation of resources which generates the greatest national income. Equity aims to reduce social and economic differences between individuals. The paper presents the major scientific research projects carried out within “Alecu Russo” Balti State University, being analysed their influence on the quality of training for academics involved in research. A qualitative and relevant higher education enables students to acquire the skills, knowledge and transferable competences they need in order to succeed after graduation to integrate on the labour market.

  15. Involvement of the kynurenine pathway in human glioma pathophysiology.

    Directory of Open Access Journals (Sweden)

    Seray Adams

    Full Text Available The kynurenine pathway (KP is the principal route of L-tryptophan (TRP catabolism leading to the production of kynurenine (KYN, the neuroprotectants, kynurenic acid (KYNA and picolinic acid (PIC, the excitotoxin, quinolinic acid (QUIN and the essential pyridine nucleotide, nicotinamide adenine dinucleotide (NAD(+. The enzymes indoleamine 2,3-dioxygenase-1 (IDO-1, indoleamine 2,3-dioxygenase-2 (IDO-2 and tryptophan 2,3-dioxygenase (TDO-2 initiate the first step of the KP. IDO-1 and TDO-2 induction in tumors are crucial mechanisms implicated to play pivotal roles in suppressing anti-tumor immunity. Here, we report the first comprehensive characterisation of the KP in 1 cultured human glioma cells and 2 plasma from patients with glioblastoma (GBM. Our data revealed that interferon-gamma (IFN-γ stimulation significantly potentiated the expression of the KP enzymes, IDO-1 IDO-2, kynureninase (KYNU, kynurenine hydroxylase (KMO and significantly down-regulated 2-amino-3-carboxymuconate semialdehyde decarboxylase (ACMSD and kynurenine aminotransferase-I (KAT-I expression in cultured human glioma cells. This significantly increased KP activity but significantly lowered the KYNA/KYN neuroprotective ratio in human cultured glioma cells. KP activation (KYN/TRP was significantly higher, whereas the concentrations of the neuroreactive KP metabolites TRP, KYNA, QUIN and PIC and the KYNA/KYN ratio were significantly lower in GBM patient plasma (n = 18 compared to controls. These results provide further evidence for the involvement of the KP in glioma pathophysiology and highlight a potential role of KP products as novel and highly attractive therapeutic targets to evaluate for the treatment of brain tumors, aimed at restoring anti-tumor immunity and reducing the capacity for malignant cells to produce NAD(+, which is necessary for energy production and DNA repair.

  16. Where's the emotion? How sport psychology can inform research on emotion in human factors.

    Science.gov (United States)

    Eccles, David W; Ward, Paul; Woodman, Tim; Janelle, Christopher M; Le Scanff, Christine; Ehrlinger, Joyce; Castanier, Carole; Coombes, Stephen A

    2011-04-01

    The aim of this study was to demonstrate how research on emotion in sport psychology might inform the field of human factors. Human factors historically has paid little attention to the role of emotion within the research on human-system relations. The theories, methods, and practices related to research on emotion within sport psychology might be informative for human factors because fundamentally, sport psychology and human factors are applied fields concerned with enhancing performance in complex, real-world domains. Reviews of three areas of theory and research on emotion in sport psychology are presented, and the relevancy of each area for human factors is proposed: (a) emotional preparation and regulation for performance, (b) an emotional trait explanation for risk taking in sport, and (c) the link between emotion and motor behavior. Finally, there are suggestions for how to continue cross-talk between human factors and sport psychology about research on emotion and related topics in the future. The relevance of theory and research on emotion in sport psychology for human factors is demonstrated. The human factors field and, in particular, research on human-system relations may benefit from a consideration of theory and research on emotion in sport psychology. Theories, methods, and practices from sport psychology might be applied usefully to human factors.

  17. Researcher Story: Stuttering

    Medline Plus

    Full Text Available ... clinical research trial. Participation involves providing a small blood sample and a ... most important aspect of humans as a group is their ability to communicate, and if you ...

  18. Methodological issues involved in conducting qualitative research on support for nurses directly involved with women who chose to terminate their pregnancy

    Directory of Open Access Journals (Sweden)

    Antoinette Gmeiner

    2001-11-01

    Full Text Available The purpose of this article is to describe the methodological issues involved in conducting qualitative research to explore and describe nurses’ experience of being directly involved with termination of pregnancies and developing guidelines for support for these nurses. Opsomming Die doel van hierdie artikel is om die metodologiese vraagstukke te beskryf rondom die uitvoer van kwalitatiewe navorsing waar verpleegkundiges se ervaring van hul direkte betrokkenheid by terminasie van swangerskap verken en beskryf is. *Please note: This is a reduced version of the abstract. Please refer to PDF for full text.

  19. The Stakeholder Model of voice research: Acknowledging barriers to human rights of all stakeholders in a communicative exchange.

    Science.gov (United States)

    Madill, Catherine; Warhurst, Samantha; McCabe, Patricia

    2018-02-01

    The act of communication is a complex, transient and often abstract phenomenon that involves many stakeholders, each of whom has their own perspective: the speaker, the listener, the observer and the researcher. Current research practices in voice disorder are frequently framed through a single lens - that of the researcher/clinician or their participant/patient. This single lens approach risks overlooking significant barriers to the basic human right of freedom of expression for those with a voice disorder as it omits consideration of the impact of voice disorder on the listener, and consideration of the wider impact of the voice in the occupational context. Recent research in the area of voice has developed a multiple lens and subsequent Stakeholder Model that acknowledges the experience and reality of multiple stakeholders viewing the same phenomenon, the voice. This research paradigm is built on Article 19 of the Universal Declaration of Human Rights as it considers the realities of all stakeholders in forming a deeper understanding of the causality, impact and aspects of communication disorder. The Stakeholder Model will be presented as a suggestion for future investigations of communication disorders more widely.

  20. Musings on privacy issues in health research involving disaggregate geographic data about individuals.

    Science.gov (United States)

    Boulos, Maged N Kamel; Curtis, Andrew J; Abdelmalik, Philip

    2009-07-20

    This paper offers a state-of-the-art overview of the intertwined privacy, confidentiality, and security issues that are commonly encountered in health research involving disaggregate geographic data about individuals. Key definitions are provided, along with some examples of actual and potential security and confidentiality breaches and related incidents that captured mainstream media and public interest in recent months and years. The paper then goes on to present a brief survey of the research literature on location privacy/confidentiality concerns and on privacy-preserving solutions in conventional health research and beyond, touching on the emerging privacy issues associated with online consumer geoinformatics and location-based services. The 'missing ring' (in many treatments of the topic) of data security is also discussed. Personal information and privacy legislations in two countries, Canada and the UK, are covered, as well as some examples of recent research projects and events about the subject. Select highlights from a June 2009 URISA (Urban and Regional Information Systems Association) workshop entitled 'Protecting Privacy and Confidentiality of Geographic Data in Health Research' are then presented. The paper concludes by briefly charting the complexity of the domain and the many challenges associated with it, and proposing a novel, 'one stop shop' case-based reasoning framework to streamline the provision of clear and individualised guidance for the design and approval of new research projects (involving geographical identifiers about individuals), including crisp recommendations on which specific privacy-preserving solutions and approaches would be suitable in each case.

  1. Research progress of non-human species radiological impact and assessment

    International Nuclear Information System (INIS)

    Bai Xiaoping; Zhu Hao; Mao Yawei; Zheng Wei; Du Hongyan

    2014-01-01

    In recent years, with the development of radiological protection conception and the improvement of requirement about non-human species protection, much more attention has been paid gradually to biota radiation impact. Research and development of non-human species protection impact and its assessment at home and abroad are introduced, then RESRAD-BIOTA and ERICA which are comparatively mature codes in the world are compared and analyzed, at last some suggestions about research and assessment work of non-human species radiological impact in the future in China are provided. (authors)

  2. Social justice and research using human biological material: A ...

    African Journals Online (AJOL)

    Social justice and research using human biological material: A response to Mahomed, Nöthling-Slabbert and Pepper. ... South African Medical Journal ... In a recent article, Mahomed, Nöthling-Slabbert and Pepper proposed that research participants should be entitled to share in the profits emanating from such research ...

  3. Improving Hawaiian and Filipino involvement in clinical research opportunities: qualitative findings from Hawai'i.

    Science.gov (United States)

    Gollin, Lisa X; Harrigan, Rosanne C; Calderón, José L; Perez, John; Easa, David

    2005-01-01

    Investigate the barriers to participation in medical research that involves Asian and Pacific Islander (API) populations in Hawai'i. Fifty people (27 Filipinos, 23 Hawaiian/Pacific Islanders) in five different communities on Oahu. Nine focus groups with an ethnically matched moderator were held to explore people's feelings, problems, and recommendations regarding medical research. Sessions were audiotaped, transcribed, and qualitatively analyzed with the constant comparison method. Only 12% of study participants said that they absolutely would not participate in a clinical study. Most agreed that research is vital. Filipino participants were more optimistic about the safety and value of joining in medical research. Hawaiian groups were more hesitant and fearful. Reasons for nonparticipation included negative feelings about the purpose and intent of clinical trials and language and cultural barriers. Suggestions on how to encourage API populations to participate in research investigations included improving peoples' understanding of the benefits to family and community. Hawaiian and Filipino groups differed only slightly in their assessments of the type of research needed in their communities. Recruitment campaigns must improve people's awareness of the process of informed consent, research safeguards, and benefits to family and community. Attention should focus on K-12 health education to use members of the younger generations to access and educate elders, involving persons with medical research experience as a recruitment resource, returning results to study participants, and increasing the number of healthcare professionals and researchers that are culturally and linguistically matched to the community.

  4. A framework for public involvement at the design stage of NHS health and social care research: time to develop ethically conscious standards.

    Science.gov (United States)

    Pandya-Wood, Raksha; Barron, Duncan S; Elliott, Jim

    2017-01-01

    Researchers who conduct studies in health and social care are encouraged to involve the public as early as possible in the process of designing their studies. Before their studies are allowed to start researchers must seek approval from a Research Ethics Committee, which will assess whether the study is going to be safe and ethical for patients or healthy volunteers to take part in. The process of ethical review does not consider how researchers work with patients and the public early on to design their studies. Furthermore, there is no requirement for researchers to seek ethical approval for public involvement. However, in our work advising researchers about public involvement we have found that the ways in which researchers involve the public in the design of their studies are sometimes unintentionally unethical, and this is the focus of our paper. We have observed ten areas where ethical issues may arise because of the actions researchers may or may not take and which might consequently have a negative impact. Therefore, we have used these observations to develop a "framework" to help researchers and the public work together at the early design stage in ways that are ethical. Our intention for the framework is to help researchers be mindful of these ten areas and how easily ethical issues can arise. The framework suggests some ways to overcome the potential issues in each of the ten areas. The ten areas are: 1) Allocating sufficient time for public involvement; 2) Avoiding tokenism; 3) Registering research design stage public involvement work with NHS Research & Development Trust Office at earliest opportunity; 4) Communicating clearly from the outset; 5) Entitling public contributors to stop their involvement for any unstated reasons; 6) Operating fairness of opportunity; 7) Differentiating qualitative research methods and public involvement activities; 8) Working sensitively; 9) Being conscious of confidentiality and 10) Valuing, acknowledging and rewarding

  5. 77 FR 67385 - National Human Genome Research Institute; Amended Notice of Meeting

    Science.gov (United States)

    2012-11-09

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Human Genome Research Institute Special Emphasis Panel, October 29, 2012, 8:00 a.m. to October 30...

  6. 78 FR 65342 - National Human Genome Research Institute; Amended Notice of Meeting

    Science.gov (United States)

    2013-10-31

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Human Genome Research Institute Special Emphasis Panel, October 17, 2013, 08:00 a.m. to October 17...

  7. 76 FR 65738 - National Human Genome Research Institute; Amended Notice of Meeting

    Science.gov (United States)

    2011-10-24

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Human Genome Research Institute Special Emphasis Panel, November 29, 2011, 8 a.m. to November 29...

  8. 76 FR 71581 - National Human Genome Research Institute; Amended Notice of Meeting

    Science.gov (United States)

    2011-11-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Human Genome Research Institute Special Emphasis Panel, November 22, 2011, 12 p.m. to November 22...

  9. Positioning the arts for intervention design research in the human services.

    Science.gov (United States)

    Moxley, David P; Calligan, Holly Feen

    2015-12-01

    The arts have been integral to the human experience fostering innovation in social arrangements, strengthening group cohesion, and merging esthetics with the utilitarian properties of technology. For intervention design research in the human services the arts can harness innovation and creativity in meeting human needs and addressing social issues. Given their capacities to stimulate expression of first person experience through interpretative strategies, the arts can equip people and groups, including researchers, with opportunities to express primary experiential knowledge through creative means, portray useful ways of meeting human needs, educate others about the social issues people experience, and formulate intervention strategies or even models to address the causes and consequences of those issues. In this paper, the authors discuss how the arts can inform and deepen human service intervention design and development and, as a result, advance innovation in the human services. They offer a rationale supporting the inclusion of the arts in the design of human service interventions, examine the contributions of the arts to the formulation of intervention concept and developmental research to further improve interventions, and consider how the arts can advance the reflexivity of intervention designers. The authors draw implications for how researchers can position the arts in the nine steps of intervention design and development the authors offer in this paper. Copyright © 2015 Elsevier Ltd. All rights reserved.

  10. Basic research on human reliability in nuclear power plants

    International Nuclear Information System (INIS)

    Zhang Li; Deng Zhiliang

    1996-10-01

    Human reliability in nuclear power plants is one of key factors in nuclear safety and economic operation. According to cognitive science, behaviour theory and ergonomic and on the bases of human cognitive behaviour characteristics, performance shaping factors, human error mechanisms and organization management, the project systematically studied the human reliability in nuclear power plant systems, established the basic theory and methods for analyzing human factor accidents and suggested feasible approaches and countermeasures for precaution against human factor accidents and improving human reliability. The achievement has been applied in operation departments, management departments and scientific research institutions of nuclear power, and has produced guiding significance and practical value to design, operation and management in nuclear power plants. (11 refs.)

  11. Aligning research assessment in the Humanities to the national Standard Evaluation Protocol Challenges and developments in the Dutch research landscape

    Energy Technology Data Exchange (ETDEWEB)

    Prins, A.; Spaapen, J.; Van Vree, F

    2016-07-01

    The purpose of this session is a debate about innovation in comprehensive methods for the assessment of humanities research. Input will come from preliminary outcomes of an ongoing project in the Netherlands to find adequate indicators for humanities research that will fit in the national Standard Evaluation Protocol. The project includes processes of ‘bottom up’ data collection (that is, with input coming from the research community) and discussion with Humanities researchers, investigating the specific characteristics of publication and communication cultures in the Humanities, and the prospects for the use of quantitative and qualitative indicators. (Author)

  12. Towards Improved Human Resource Development In Nigeria ...

    African Journals Online (AJOL)

    Towards Improved Human Resource Development In Nigeria: Challenges And Prospects. ... Journal of Research in National Development ... Consequently, the paper recommended; improved investment in education, implementable policies on human resource development, involvement of private organization in human ...

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

    Energy Technology Data Exchange (ETDEWEB)

    Curt Braun; John Grimes; Eric Shaver; Ronald Boring (Principal Investigator)

    2011-09-01

    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.

  14. Critical survey of research on human factors and the man-machine interaction

    International Nuclear Information System (INIS)

    Watson, L.A.

    1984-01-01

    A case is developed for placing a high priority on research into human factors in the nuclear power industry. This is based essentially on the fact that human error is a significant factor in plant reliability and the assurance of safety. Control of human error can therefore produce benefits in the reduction of both operational costs and public risk. Descriptions are given of activities initiated by the Commission of the European Communities in conjunction with institutes within the Member States. These include: a comprehensive survey and analysis of current relevant work; considerations of classification schemes for human factors activities; the use of simulators for human factors research; and a proposed European collaborative research programme. (author)

  15. Research Techniques in Biomechanics.

    Science.gov (United States)

    Ward, Terry

    Biomechanics involves the biological human beings interacting with his/her mechanical environment. Biomechanics research is being done in connection with sport, physical education, and general motor behavior, and concerns mechanics independent of implements. Biomechanics research falls in the following two general categories: (1) that specific…

  16. Ethical Issues in the Use of Humans for Research.

    Science.gov (United States)

    Bashaw, W. L.

    The APA Ethical Principles, the University of Georgia policy, standard research texts, and research literature on specific methodologies, all in relation to ethical issues in human research, are discussed. The 10 APA principles state, in essence, that the investigator is responsible for what happens, that confidentiality and the protection of the…

  17. 77 FR 55853 - National Human Genome Research Institute; Amended Notice of Meeting

    Science.gov (United States)

    2012-09-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute; Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Advisory Council for Human Genome Research, September 10, 2012, 8:30 a.m. to September 11, 2012, 5...

  18. A LARGE HUMAN CENTRIFUGE FOR EXPLORATION AND EXPLOITATION RESEARCH

    Directory of Open Access Journals (Sweden)

    Jack J.W.A. van Loon

    2012-06-01

    Full Text Available This paper addresses concepts regarding the development of an Altered Gravity Platform (AGP that will serve as a research platform for human space exploration. Space flight causes a multitude of physiological problems, many of which are due to gravity level transitions. Going from Earth's gravity to microgravity generates fluid shifts, space motion sickness, cardiovascular deconditioning among other changes, and returning to a gravity environment again puts the astronauts under similar stressors. A prolonged stay in microgravity provokes additional deleterious changes such as bone loss, muscle atrophy and loss of coordination or specific psychological stresses. To prepare for future manned space exploration missions, a ground-based research test bed for validating countermeasures against the deleterious effects of g-level transitions is needed. The proposed AGP is a large rotating facility (diameter > 150 m, where gravity levels ranging from 1.1 to 1.5g are generated, covering short episodes or during prolonged stays of weeks or even months. On this platform, facilities are built where a crew of 6 to 8 humans can live autonomously. Adaptation from 1 g to higher g levels can be studied extensively and monitored continuously. Similarly, re-adaptation back to 1 g, after a prolonged period of altered g can also be investigated. Study of the physiological and psychological adaptation to changing g-levels will provide instrumental and predictive knowledge to better define the ultimate countermeasures that are needed for future successful manned space exploration missions to the Moon, Mars and elsewhere. The AGP initiative will allow scientific top experts in Europe and worldwide to investigate the necessary scientific, operational, and engineering inputs required for such space missions. Because so many different physiological systems are involved in adaptation to gravity levels, a multidisciplinary approach is crucial. One of the final and crucial

  19. Research review and development trends of human reliability analysis techniques

    International Nuclear Information System (INIS)

    Li Pengcheng; Chen Guohua; Zhang Li; Dai Licao

    2011-01-01

    Human reliability analysis (HRA) methods are reviewed. The theoretical basis of human reliability analysis, human error mechanism, the key elements of HRA methods as well as the existing HRA methods are respectively introduced and assessed. Their shortcomings,the current research hotspot and difficult problems are identified. Finally, it takes a close look at the trends of human reliability analysis methods. (authors)

  20. 77 FR 27471 - National Human Genome Research Institute Amended Notice of Meeting

    Science.gov (United States)

    2012-05-10

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome Research Institute Amended Notice of Meeting Notice is hereby given of a change in the meeting of the National Advisory Council for Human Genome Research, May 21, 2012, 8:30 a.m. to May 22, 2012, 5:00 p.m...

  1. Human dimensions in cyber operations research and development priorities.

    Energy Technology Data Exchange (ETDEWEB)

    Forsythe, James Chris; Silva, Austin Ray; Stevens-Adams, Susan Marie; Bradshaw, Jeffrey [Institute for Human and Machine Cognition

    2012-11-01

    Within cyber security, the human element represents one of the greatest untapped opportunities for increasing the effectiveness of network defenses. However, there has been little research to understand the human dimension in cyber operations. To better understand the needs and priorities for research and development to address these issues, a workshop was conducted August 28-29, 2012 in Washington DC. A synthesis was developed that captured the key issues and associated research questions. Research and development needs were identified that fell into three parallel paths: (1) human factors analysis and scientific studies to establish foundational knowledge concerning factors underlying the performance of cyber defenders; (2) development of models that capture key processes that mediate interactions between defenders, users, adversaries and the public; and (3) development of a multi-purpose test environment for conducting controlled experiments that enables systems and human performance measurement. These research and development investments would transform cyber operations from an art to a science, enabling systems solutions to be engineered to address a range of situations. Organizations would be able to move beyond the current state where key decisions (e.g. personnel assignment) are made on a largely ad hoc basis to a state in which there exist institutionalized processes for assuring the right people are doing the right jobs in the right way. These developments lay the groundwork for emergence of a professional class of cyber defenders with defined roles and career progressions, with higher levels of personnel commitment and retention. Finally, the operational impact would be evident in improved performance, accompanied by a shift to a more proactive response in which defenders have the capacity to exert greater control over the cyber battlespace.

  2. Calretinin as a marker for premotor neurons involved in upgaze in human brainstem

    Directory of Open Access Journals (Sweden)

    Christopher eAdamczyk

    2015-12-01

    Full Text Available Eye movements are generated by different premotor pathways. Damage to them can cause specific deficits of eye movements, such as saccades. For correlative clinico-anatomical post-mortem studies of cases with eye movement disorders it is essential to identify the functional cell groups of the oculomotor system in the human brain by marker proteins. Based on monkey studies, the premotor neurons of the saccadic system can be identified by the histochemical markers parvalbumin and perineuronal nets in humans. These areas involve the interstitial nucleus of Cajal (INC and the rostral interstitial nucleus of the medial longitudinal fascicle (RIMLF, which both contain premotor neurons for upgaze and downgaze. Recent monkey and human studies revealed a selective excitatory calretinin-positive input to the motoneurons mediating upgaze, but not to those for downgaze. Three premotor regions were identified as sources of calretinin input in monkey: y-group, INC and RIMLF. These findings suggest that the expression pattern of parvalbumin and calretinin may help to identify premotor neurons involved in up- or downgaze. In a post-mortem study of five human cases without neurological diseases we investigated the y-group, INC and RIMLF for the presence of parvalbumin and calretinin positive neurons including their co-expression. Adjacent thin paraffin sections were stained for the aggrecan component of perineuronal nets, parvalbumin or calretinin and glutamate decarboxylase. The comparative analysis of scanned thin sections of INC and RIMLF revealed medium-sized parvalbumin positive neurons with and without calretinin coexpression, which were intermingled. The parvalbumin/calretinin positive neurons in both nuclei are considered as excitatory premotor upgaze neurons. Accordingly, the parvalbumin-positive neurons lacking calretinin are considered as premotor downgaze neurons in RIMLF, but may in addition include inhibitory premotor upgaze neurons in the INC as

  3. MOLECULAR ANALYSIS OF HUMAN SPERMATOZOA: POTENTIAL FOR INFERTILITY RESEARCH

    Science.gov (United States)

    Gordon Research Conference: Mammalian Gametogenesis and Embryogenesis New London, CT, July 1-6, 2000Molecular Analysis of Human Spermatozoa: Potential for Infertility ResearchDavid Miller 1, David Dix2, Robert Reid 3, Stephen A Krawetz 3 1Reproductive ...

  4. Research and development studies on human factors: new trends

    International Nuclear Information System (INIS)

    Llory, M.; Larchier-Boulanger, J.

    1988-01-01

    This paper is aimed at describing where the research work on human factors undertaken at EDF stands in relation to this European trend and to define the problematics of cognitive phenomena in relation to all (non cognitive) human phenomena, on the one hand, and to individual aspects as compared to collective and organizational aspects, on the other. Some important trends in the research and development studies will thus be examined one lay one: - analysis of operators' activity; - analysis of the activity cognitive aspects; - problem of the impact of non-cognitive aspects

  5. A clash of paradigms? Western and indigenous views on health research involving Aboriginal peoples.

    Science.gov (United States)

    Campbell, Theresa Diane

    2014-07-01

    To explore the issues of data management and data ownership with regard to health research conducted in aboriginal or indigenous populations in Canada. Research with aboriginal communities in Canada has often been conducted by researchers who had little or no understanding of the community in which the research was taking place. This led to 'helicopter' research, which benefitted the researcher but not the community. National aboriginal leadership developed the ownership, control, access, and possession (OCAP) principles, which outline how to manage research data regarding aboriginal people and to counteract disrespectful methodologies. However, these principles present their own set of challenges to those who would conduct research with aboriginal populations. Documents from the Assembly of First Nations, the Government of Canada, Aboriginal writers and researchers, and Nursing theorists and researchers. This is a methodology paper that reviews the issues of data ownership when conducting research with Aboriginal populations. The authors explore indigenous and Western views of knowledge development, outline and discuss the OCAP principles, and present the Canadian Institute of Health Research's guidelines for health research involving aboriginal people as a guide for those who want to carry out ethical and culturally competent research, do no harm and produce research that can benefit aboriginal peoples. There are special considerations associated with conducting research with Aboriginal populations. The Assembly of First Nations wants researchers to use the Ownership, Control, Access and Possession (OCAP) principles with First Nations data. These principles are restrictive and need to be discussed with stakeholders before research is undertaken. In Canada, it is imperative that researchers use the Canadian Institute of Health Research Guidelines for Health Research Involving Aboriginal People to ensure culturally sensitive and ethical conduct during the course of

  6. RESEARCH ON HUMAN RESOURCES MOTIVATION AND SATISFACTION

    Directory of Open Access Journals (Sweden)

    Zoltan-Bela FARKAS

    2014-06-01

    Full Text Available Many research studies on the human resources performance of the educational system have proved that pupils/students’ educational success depends, to a high degree, on the level of human resource motivation, as well as on their degree of professional satisfaction. Teachers’ who show a high level of motivation, both intrinsic and extrinsic, invest more into their activity, are more creative and more efficient in problem solving. The paper debates the results of an empirical study regarding the influence of pre-university teachers’ motivation and satisfaction regarding the general work conditions on their work performance by measuring the present motivation and satisfaction level. Furthermore, the determinant factors of their satisfaction with the work place are determined and analyzed. Finally, based on the statistical data process we will conclude and debate on the research hypothesis validation and the empirical model related to motivation – satisfaction – performance interdependences.

  7. Focus on CSIR research in water resources: water and human health research in CSIR

    CSIR Research Space (South Africa)

    Genthe, Bettina

    2007-08-01

    Full Text Available The Water and Human Health team researches water related science to address the CSIR’s mandate, national priorities and to improve quality of life for all. The overall aim of the research is to achieve a sustainable balance between the use of water...

  8. Musings on privacy issues in health research involving disaggregate geographic data about individuals

    Directory of Open Access Journals (Sweden)

    AbdelMalik Philip

    2009-07-01

    Full Text Available Abstract This paper offers a state-of-the-art overview of the intertwined privacy, confidentiality, and security issues that are commonly encountered in health research involving disaggregate geographic data about individuals. Key definitions are provided, along with some examples of actual and potential security and confidentiality breaches and related incidents that captured mainstream media and public interest in recent months and years. The paper then goes on to present a brief survey of the research literature on location privacy/confidentiality concerns and on privacy-preserving solutions in conventional health research and beyond, touching on the emerging privacy issues associated with online consumer geoinformatics and location-based services. The 'missing ring' (in many treatments of the topic of data security is also discussed. Personal information and privacy legislations in two countries, Canada and the UK, are covered, as well as some examples of recent research projects and events about the subject. Select highlights from a June 2009 URISA (Urban and Regional Information Systems Association workshop entitled 'Protecting Privacy and Confidentiality of Geographic Data in Health Research' are then presented. The paper concludes by briefly charting the complexity of the domain and the many challenges associated with it, and proposing a novel, 'one stop shop' case-based reasoning framework to streamline the provision of clear and individualised guidance for the design and approval of new research projects (involving geographical identifiers about individuals, including crisp recommendations on which specific privacy-preserving solutions and approaches would be suitable in each case.

  9. Academic research as human activity: Occupational Therapy contributions for consumer participation

    Directory of Open Access Journals (Sweden)

    Tatiana Dimov

    2016-07-01

    Full Text Available The involvement of consumers in research is a recent trend in the world. Involving consumers in researches on health services, therapeutic approaches, effectiveness of support groups, mutual help groups, and even on medication is crucial for obtaining academic results that are representative of the group of consumers, and influence public policies that are effective and functional for consumers. This paper presents an analysis of how consumers can get involved in a research and what can be the role of an occupational therapist in such activity. When governed by the principles of autonomy, empowerment, and recovery, researches with consumer participation promote the principles of equality and recognition, allowing inclusion in the research process, and promoting the recognition of consumer knowledge. As an activity, research can be a motivator, mobilizing wills and desires. It can also be a possibility of leaving stagnation and making decisions. The occupational therapist can help this process. Occupational therapy focus on activities that are significant to the life of individuals. Participation in research becomes a focus for the therapeutic process to the extent that it presents itself as a demand for the client.

  10. "…Their Opinions Mean Something": Care Staff's Attitudes to Health Research Involving People with Intellectual Disabilities

    Science.gov (United States)

    Hall, Natalie; Durand, Marie-Anne; Mengoni, Silvana E.

    2017-01-01

    Background: Despite experiencing health inequalities, people with intellectual disabilities are under-represented in health research. Previous research has identified barriers but has typically focused on under-recruitment to specific studies. This study aimed to explore care staff's attitudes to health research involving people with intellectual…

  11. Operational safety related human engineering research in Finland

    International Nuclear Information System (INIS)

    Haapanen, P.; Wahlstroem, B.

    1984-01-01

    Human errors contribute considerably to the total risk of the nuclear power plants as was clearly demonstrated at the TMI-accident in 1979. This fact was recognized early in Finland and a comprehensive research program was established in the second half of the 1970s. This paper gives a short description of some research projects in this program. (author)

  12. Chronic Low Dose Rate Ionizing Radiation Exposure Induces Premature Senescence in Human Fibroblasts that Correlates with Up Regulation of Proteins Involved in Protection against Oxidative Stress

    Directory of Open Access Journals (Sweden)

    Olga Loseva

    2014-07-01

    Full Text Available The risks of non-cancerous diseases associated with exposure to low doses of radiation are at present not validated by epidemiological data, and pose a great challenge to the scientific community of radiation protection research. Here, we show that premature senescence is induced in human fibroblasts when exposed to chronic low dose rate (LDR exposure (5 or 15 mGy/h of gamma rays from a 137Cs source. Using a proteomic approach we determined differentially expressed proteins in cells after chronic LDR radiation compared to control cells. We identified numerous proteins involved in protection against oxidative stress, suggesting that these pathways protect against premature senescence. In order to further study the role of oxidative stress for radiation induced premature senescence, we also used human fibroblasts, isolated from a patient with a congenital deficiency in glutathione synthetase (GS. We found that these GS deficient cells entered premature senescence after a significantly shorter time of chronic LDR exposure as compared to the GS proficient cells. In conclusion, we show that chronic LDR exposure induces premature senescence in human fibroblasts, and propose that a stress induced increase in reactive oxygen species (ROS is mechanistically involved.

  13. Sulfogalactosylglycerolipid is involved in human gamete interaction.

    Science.gov (United States)

    Weerachatyanukul, W; Rattanachaiyanont, M; Carmona, E; Furimsky, A; Mai, A; Shoushtarian, A; Sirichotiyakul, S; Ballakier, H; Leader, A; Tanphaichitr, N

    2001-12-01

    Recent results from our laboratory have revealed the role of sulfogalactosylglycerolipid (SGG) in mouse sperm-zona pellucida (ZP) binding. In this report, we demonstrated the presence of SGG in Percoll-gradient centrifuged (PGC) human sperm by high performance thin layer chromatography with orcinol and Azure A staining, specific for glycolipids and sulfolipids, respectively. SGG in human PGC sperm was quantified by its affinity to Azure A to be 12-15 mol% of sperm lipids. Indirect immunofluorescence revealed that SGG existed on both live and aldehyde fixed human sperm in the head region. Pretreatment of human PGC sperm with affinity purified antiSGG Fab markedly inhibited sperm binding to the ZP in a concentration dependent manner, without any changes in the spontaneous acrosome rate or sperm motility parameters. Fluorescently labeled SGG liposomes also bound uniformly to isolated human ZP, while fluorescently labeled galactosylglycerolipid (GG, SGG's parental lipid) or phosphatidylserine (PS, negatively charged like SGG) liposomes did not. All of these results suggested the role of human sperm SGG in ZP binding. Copyright 2001 Wiley-Liss, Inc.

  14. Does Every Research Library Need a Digital Humanities Center?

    Science.gov (United States)

    Schaffner, Jennifer; Erway, Ricky

    2014-01-01

    The digital humanities (DH) are attracting considerable attention and funding at the same time that this nascent field is striving for an identity. Some research libraries are making significant investments by creating digital humanities centers. However, questions about whether such investments are warranted persist across the cultural heritage…

  15. Consensus standards for introductory e-learning courses in human participants research ethics.

    Science.gov (United States)

    Williams, John R; Sprumont, Dominique; Hirtle, Marie; Adebamowo, Clement; Braunschweiger, Paul; Bull, Susan; Burri, Christian; Czarkowski, Marek; Fan, Chien Te; Franck, Caroline; Gefenas, Eugenjius; Geissbuhler, Antoine; Klingmann, Ingrid; Kouyaté, Bocar; Kraehenbhul, Jean-Pierre; Kruger, Mariana; Moodley, Keymanthri; Ntoumi, Francine; Nyirenda, Thomas; Pym, Alexander; Silverman, Henry; Tenorio, Sara

    2014-06-01

    This paper reports the results of a workshop held in January 2013 to begin the process of establishing standards for e-learning programmes in the ethics of research involving human participants that could serve as the basis of their evaluation by individuals and groups who want to use, recommend or accredit such programmes. The standards that were drafted at the workshop cover the following topics: designer/provider qualifications, learning goals, learning objectives, content, methods, assessment of participants and assessment of the course. The authors invite comments on the draft standards and eventual endorsement of a final version by all stakeholders. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  16. Possible Involvement of Human Mast Cells in the Establishment of Pregnancy via Killer Cell Ig-Like Receptor 2DL4.

    Science.gov (United States)

    Ueshima, Chiyuki; Kataoka, Tatsuki R; Hirata, Masahiro; Sugimoto, Akihiko; Iemura, Yoshiki; Minamiguchi, Sachiko; Nomura, Takashi; Haga, Hironori

    2018-06-01

    The involvement of mast cells in the establishment of pregnancy is unclear. Herein, we found that human mast cells are present in the decidual tissues of parous women and expressed a human-specific protein killer cell Ig-like receptor (KIR) 2DL4, a receptor for human leukocyte antigen G expressed on human trophoblasts. In contrast, decreased numbers of decidual mast cells and reduced KIR2DL4 expression were observed in these cells of infertile women who had undergone long-term corticosteroid treatment. Co-culture of the human mast cell line, LAD2, and human trophoblast cell line, HTR-8/SVneo, accelerated the migration and tube formation of HTR-8/SVneo cells in a KIR2DL4-dependent manner. These observations suggest the possible involvement of human mast cells in the establishment of pregnancy via KIR2DL4 and that long-term corticosteroid treatment may cause infertility by influencing the phenotypes of decidual mast cells. Copyright © 2018 American Society for Investigative Pathology. Published by Elsevier Inc. All rights reserved.

  17. 77 FR 64816 - National Human Genome Research Institute; Notice of Meeting

    Science.gov (United States)

    2012-10-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute. The meeting will be open to the public as indicated below, with... invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Human Genome...

  18. 76 FR 65204 - National Human Genome Research Institute; Notice of Meeting

    Science.gov (United States)

    2011-10-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute. The meeting will be open to the public as indicated below, with... invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Human Genome...

  19. 75 FR 60467 - National Human Genome Research Institute; Notice of Meeting

    Science.gov (United States)

    2010-09-30

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., National Human Genome Research Institute. The meeting will be open to the public as indicated below, with... invasion of personal privacy. Name of Committee: Board of Scientific Counselors, National Human Genome...

  20. Human and animal research guidelines: aligning ethical constructs with new scientific developments.

    Science.gov (United States)

    Ferdowsian, Hope

    2011-10-01

    Both human research and animal research operate within established standards and procedures. Although the human research environment has been criticized for its sometimes inefficient and imperfect process, reported abuses of human subjects in research served as the impetus for the establishment of the Nuremberg Code, Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the resulting Belmont Report. No similar, comprehensive and principled effort has addressed the use of animals in research. Although published policies regarding animal research provide relevant regulatory guidance, these policies have not emerged from the process of specifying consistent and reasoned ethical principles. The lack of a fundamental effort to explore the ethical issues and principles regarding the use of animals in research has led to unclear and disparate policies. Recent studies have increased our understanding of animal cognition and emotion, suggesting that animals' potential for experiencing a wide variety of harms, such as pain and fear, is greater than has been previously appreciated. Furthermore, relationships between methods of captivity and certain laboratory procedures and the resulting adverse physical, social and psychological effects have been established. In light of this information, current protections may need to be reconsidered and modified. This paper explores the historical convergence and divergence in the creation of human and animal research guidelines, as well as opportunities to align ethical frameworks with new scientific discoveries. © 2011 Blackwell Publishing Ltd.

  1. Potential human factors research relating to modern technology in nuclear power plants

    International Nuclear Information System (INIS)

    Ketchel, J.; Fink, R.; Hanes, L.; Williges, R.; Williges, B.

    1994-01-01

    This paper discusses proposed human factors research to address advanced human-machine interface technology in nuclear power plants. It relates to a current EPRI project to identify a prioritized list of specific research issues that could be assessed to improve control room and other user interface areas. The project seeks to bridge the gap between the functional requirements of advanced design initiatives and the human factors research needed to support them. It seeks to identify potential benefits to be expected, as well as potential problems that might be introduced by advanced technology. It provides an organized approach to identifying human factors research needs, information already available, and measures of performance and effectiveness that might be used to assess the value of potential improvements. Those parts of the proposed plan that are subsequently approved by EPRI management and by the utility advisory committee will provide a basis for recommending research priorities

  2. Humanities for the Environment—A Manifesto for Research and Action

    Directory of Open Access Journals (Sweden)

    Poul Holm

    2015-12-01

    Full Text Available Human preferences, practices and actions are the main drivers of global environmental change in the 21st century. It is crucial, therefore, to promote pro-environmental behavior. In order to accomplish this, we need to move beyond rational choice and behavioral decision theories, which do not capture the full range of commitments, assumptions, imaginaries, and belief systems that drive those preferences and actions. Humanities disciplines, such as philosophy, history, religious studies, gender studies, language and literary studies, psychology, and pedagogics do offer deep insights into human motivations, values, and choices. We believe that the expertise of such fields for transforming human preferences, practices and actions is ignored at society’s peril. We propose an agenda that focuses global humanities research on stepping up to the challenges of planetary environmental change. We have established Environmental Humanities Observatories through which to observe, explore and enact the crucial ways humanistic disciplines may help us understand and engage with global ecological problems by providing insight into human action, perceptions, and motivation. We present this Manifesto as an invitation for others to join the “Humanities for the Environment” open global consortium of humanities observatories as we continue to develop a shared research agenda.

  3. Storytelling as a way for humanizing research methods

    OpenAIRE

    Grenness, Tor

    2016-01-01

    This is an Open Access journal. The article is aslo available from www.idrcentre.org This article examines how the use of storytelling can serve as a pedagogical strategy in the teaching of research methods. Research methods and statistics anxiety is fairly widespread among students in higher education. Introducing storytelling has been found to decrease this anxiety. The term “humanizing research methods” implies a focus on students’ needs that goes beyond transferring knowledge of the co...

  4. The value of respect in human research ethics: a conceptual analysis and a practical guide.

    Science.gov (United States)

    Pieper, I J; Thomson, C J H

    2014-01-01

    In order to continue to maintain public trust and confidence in human research, participants must be treated with respect. Researchers and Human Research Ethics Committee members need to be aware that modern considerations of this value include: the need for a valid consenting process, the protection of participants who have their capacity for consent compromised; the promotion of dignity for participants; and the effects that human research may have on cultures and communities. This paper explains the prominence of respect as a value when considering the ethics of human research and provides practical advice for both researchers and Human Research Ethics Committee members in developing respectful research practices.

  5. Courts, legislators and human embryo research: lessons from Ireland.

    Science.gov (United States)

    Binchy, William

    2011-01-01

    When it comes to the matter of human embryo research law plays a crucial role in its development by helping to set the boundaries of what may be done, the sanctions for acting outside those boundaries and the rights and responsibilities of key parties. Nevertheless, the philosophical challenges raised by human embryo research, even with the best will of all concerned, may prove too great for satisfactory resolution through the legal process. Taking as its focus the position of Ireland, this paper explores the distinctive constitutional approach taken on this issue and addresses the difficulty of translating sound philosophy into judicial decrees and the difficulty of establishing expert commissions to make law reform proposals on matters of profound normative controversy. It concludes that the Irish experience does have useful lessons for those in other countries who are concerned with the legal approach to research on human embryos and points to the desirability of a diversity of normative positions in order to enrich the quality of the analysis so as to encourage more informed debate in society.

  6. Human eosinophils - potential pharmacological model applied in human histamine H4 receptor research.

    Science.gov (United States)

    Grosicki, Marek; Kieć-Kononowicz, Katarzyna

    2015-01-01

    Histamine and histamine receptors are well known for their immunomodulatory role in inflammation. In this review we describe the role of histamine and histamine H4 receptor on human eosinophils. In the first part of article we provide short summary of histamine and histamine receptors role in physiology and histamine related therapeutics used in clinics. We briefly describe the human histamine receptor H4 and its ligands, as well as human eosinophils. In the second part of the review we provide detailed description of known histamine effects on eosinophils including: intracellular calcium concentration flux, actin polymerization, cellular shape change, upregulation of adhesion proteins and cellular chemotaxis. We provide proofs that these effects are mainly connected with the activation of histamine H4 receptor. When examining experimental data we discuss the controversial results and limitations of the studies performed on isolated eosinophils. In conclusion we believe that studies on histamine H4 receptor on human eosinophils can provide interesting new biomarkers that can be used in clinical studies of histamine receptors, that in future might result in the development of new strategies in the treatment of chronic inflammatory conditions like asthma or allergy, in which eosinophils are involved.

  7. Ethics review of health research on human participants in South Africa.

    Science.gov (United States)

    van Wyk, Christa

    2010-06-01

    In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

  8. Managing Watersheds as Couple Human-Natural Systems: A Review of Research Opportunities

    Science.gov (United States)

    Cai, X.

    2011-12-01

    evidenced by 1) institutional innovation for integrated watershed management; 2) real-world management practices involving multidisciplinary expertise; 3) growing role of economics in systems analysis; 4) enhanced research programs such as the CHNS program and Water, Sustainability and Climate (WSC) program at the US National Science Foundation (NSF). Furthermore, recent scientific and technological developments are expected to accommodate integrated watershed system analysis approaches, such as: 1) increasing availability of distributed digital datasets especially from remote sensing products (e.g. digital watersheds); 2) distributed and semi-distributed watershed hydrologic modeling; 3) enhanced hydroclimatic monitoring and forecast; 4) identified evidences of vulnerability and threshold behavior of watersheds; and 5) continuing improvements in computational and optimization algorithms. Managing watersheds as CHNS will be critical for watershed sustainability, which ensures that human societies will benefit forever from the watershed through development of harmonious relationships between human and natural systems. This presentation will provide a review of the research opportunities that take advantage of the concept of CHNS and associated scientific, technological and institutional innovations/developments.

  9. [Research progress on free radicals in human body].

    Science.gov (United States)

    Wang, Q B; Xu, F P; Wei, C X; Peng, J; Dong, X D

    2016-08-10

    Free radicals are the intermediates of metabolism, widely exist in the human bodies. Under normal circumstances, the free radicals play an important role in the metabolic process on human body, cell signal pathway, gene regulation, induction of cell proliferation and apoptosis, so as to maintain the normal growth and development of human body and to inhibit the growth of bacteria, virus and cancer. However, when organic lesion occurs affected by external factors or when equilibrium of the free radicals is tipped in the human body, the free radicals will respond integratedly with lipids, protein or nucleic acid which may jeopardize the health of human bodies. This paper summarizes the research progress of the free radicals conducted in recent years, in relations to the perspective of the types, origins, test methods of the free radicals and their relationship with human's health. In addition, the possible mechanisms of environmental pollutants (such as polycyclic aromatic hydrocarbons) mediating oxidative stress and free radicals scavenging in the body were also summarized.

  10. Cellular and molecular effect of MEHP Involving LXRα in human fetal testis and ovary.

    Science.gov (United States)

    Muczynski, Vincent; Lecureuil, Charlotte; Messiaen, Sébastien; Guerquin, Marie-Justine; N'tumba-Byn, Thierry; Moison, Delphine; Hodroj, Wassim; Benjelloun, Hinde; Baijer, Jan; Livera, Gabriel; Frydman, René; Benachi, Alexandra; Habert, René; Rouiller-Fabre, Virginie

    2012-01-01

    Phthalates have been shown to have reprotoxic effects in rodents and human during fetal life. Previous studies indicate that some members of the nuclear receptor (NR) superfamilly potentially mediate phthalate effects. This study aimed to assess if expression of these nuclear receptors are modulated in the response to MEHP exposure on the human fetal gonads in vitro. Testes and ovaries from 7 to 12 gestational weeks human fetuses were exposed to 10(-4)M MEHP for 72 h in vitro. Transcriptional level of NRs and of downstream genes was then investigated using TLDA (TaqMan Low Density Array) and qPCR approaches. To determine whether somatic or germ cells of the testis are involved in the response to MEHP exposure, we developed a highly efficient cytometric germ cell sorting approach. In vitro exposure of fetal testes and ovaries to MEHP up-regulated the expression of LXRα, SREBP members and of downstream genes involved in the lipid and cholesterol synthesis in the whole gonad. In sorted testicular cells, this effect is only observable in somatic cells but not in the gonocytes. Moreover, the germ cell loss induced by MEHP exposure, that we previously described, is restricted to the male gonad as oogonia density is not affected in vitro. We evidenced for the first time that phthalate increases the levels of mRNA for LXRα, and SREBP members potentially deregulating lipids/cholesterol synthesis in human fetal gonads. Interestingly, this novel effect is observable in both male and female whereas the germ cell apoptosis is restricted to the male gonad. Furthermore, we presented here a novel and potentially very useful flow cytometric cell sorting method to analyse molecular changes in germ cells versus somatic cells.

  11. Cellular and molecular effect of MEHP Involving LXRα in human fetal testis and ovary.

    Directory of Open Access Journals (Sweden)

    Vincent Muczynski

    Full Text Available Phthalates have been shown to have reprotoxic effects in rodents and human during fetal life. Previous studies indicate that some members of the nuclear receptor (NR superfamilly potentially mediate phthalate effects. This study aimed to assess if expression of these nuclear receptors are modulated in the response to MEHP exposure on the human fetal gonads in vitro.Testes and ovaries from 7 to 12 gestational weeks human fetuses were exposed to 10(-4M MEHP for 72 h in vitro. Transcriptional level of NRs and of downstream genes was then investigated using TLDA (TaqMan Low Density Array and qPCR approaches. To determine whether somatic or germ cells of the testis are involved in the response to MEHP exposure, we developed a highly efficient cytometric germ cell sorting approach. In vitro exposure of fetal testes and ovaries to MEHP up-regulated the expression of LXRα, SREBP members and of downstream genes involved in the lipid and cholesterol synthesis in the whole gonad. In sorted testicular cells, this effect is only observable in somatic cells but not in the gonocytes. Moreover, the germ cell loss induced by MEHP exposure, that we previously described, is restricted to the male gonad as oogonia density is not affected in vitro.We evidenced for the first time that phthalate increases the levels of mRNA for LXRα, and SREBP members potentially deregulating lipids/cholesterol synthesis in human fetal gonads. Interestingly, this novel effect is observable in both male and female whereas the germ cell apoptosis is restricted to the male gonad. Furthermore, we presented here a novel and potentially very useful flow cytometric cell sorting method to analyse molecular changes in germ cells versus somatic cells.

  12. Structural insights into human Kif7, a kinesin involved in Hedgehog signalling

    Energy Technology Data Exchange (ETDEWEB)

    Klejnot, Marta, E-mail: m.klejnot@beatson.gla.ac.uk; Kozielski, Frank, E-mail: m.klejnot@beatson.gla.ac.uk [The Beatson Institute for Cancer Research, Garscube Estate, Switchback Road, Glasgow G61 1BD, Scotland (United Kingdom)

    2012-02-01

    The human Kif7 motor domain structure provides insights into a kinesin of medical significance. Kif7, a member of the kinesin 4 superfamily, is implicated in a variety of diseases including Joubert, hydrolethalus and acrocallosal syndromes. It is also involved in primary cilium formation and the Hedgehog signalling pathway and may play a role in cancer. Its activity is crucial for embryonic development. Kif7 and Kif27, a closely related kinesin in the same subfamily, are orthologues of the Drosophila melano@@gaster kinesin-like protein Costal-2 (Cos2). In vertebrates, they work together to fulfil the role of the single Cos2 gene in Drosophila. Here, the high-resolution structure of the human Kif7 motor domain is reported and is compared with that of conventional kinesin, the founding member of the kinesin superfamily. These data are a first step towards structural characterization of a kinesin-4 family member and of this interesting molecular motor of medical significance.

  13. Research Involving Health Providers and Managers: Ethical Issues Faced by Researchers Conducting Diverse Health Policy and Systems Research in Kenya.

    Science.gov (United States)

    Molyneux, Sassy; Tsofa, Benjamin; Barasa, Edwine; Nyikuri, Mary Muyoka; Waweru, Evelyn Wanjiku; Goodman, Catherine; Gilson, Lucy

    2016-12-01

    There is a growing interest in the ethics of Health Policy and Systems Research (HPSR), and especially in areas that have particular ethical salience across HPSR. Hyder et al (2014) provide an initial framework to consider this, and call for more conceptual and empirical work. In this paper, we respond by examining the ethical issues that arose for researchers over the course of conducting three HPSR studies in Kenya in which health managers and providers were key participants. All three studies involved qualitative work including observations and individual and group interviews. Many of the ethical dilemmas researchers faced only emerged over the course of the fieldwork, or on completion, and were related to interactions and relationships between individuals operating at different levels or positions in health/research systems. The dilemmas reveal significant ethical challenges for these forms of HPSR, and show that potential 'solutions' to dilemmas often lead to new issues and complications. Our experiences support the value of research ethics frameworks, and suggest that these can be enriched by incorporating careful consideration of context embedded social relations into research planning and conduct. Many of these essential relational elements of ethical practice, and of producing quality data, are given stronger emphasis in social science research ethics than in epidemiological, clinical or biomedical research ethics, and are particularly relevant where health systems are understood as social and political constructs. We conclude with practical and research implications. © 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.

  14. User involvement in the design of human-computer interactions: some similarities and differences between design approaches

    NARCIS (Netherlands)

    Bekker, M.M.; Long, J.B.

    1998-01-01

    This paper presents a general review of user involvement in the design of human-computer interactions, as advocated by a selection of different approaches to design. The selection comprises User-Centred Design, Participatory Design, Socio-Technical Design, Soft Systems Methodology, and Joint

  15. Human Research Program Human Health Countermeasures Element Nutrition Risk Standing Review Panel

    Science.gov (United States)

    Bistrian, Bruce

    2009-01-01

    The Nutrition Risk Standing Review Panel (SRP) reviewed and discussed the specific gaps and tasks for the Human Health Countermeasures (HHC) Element related to nutrition identified in the Human Research Program (HRP) Integrated Research Plan. There was general consensus that the described gaps and proposed tasks were critical to future NASA mission success. The SRP acknowledged the high scientific quality of the work currently being undertaken by the Nutritional Biochemistry group under the direction of Dr. Scott Smith. In review of the entire HRP, four new gaps were identified that complement the Element's existing research activities. Given the limitations of ground-based analogs for many of the unique physiological and metabolic alterations in space, future studies are needed to quantify nutritional factors that change during actual space flight. In addition, future tasks should seek to better evaluate the time course of physiological and metabolic alterations during flight to better predict alterations during longer duration missions. Finally, given the recent data suggesting a potential role for increased inflammatory responses during space flight, the role of inflammation needs to be explored in detail, including the development of potential countermeasures and new ground based analogs, if this possibility is confirmed.

  16. Telomere disruption results in non-random formation of de novo dicentric chromosomes involving acrocentric human chromosomes.

    Directory of Open Access Journals (Sweden)

    Kaitlin M Stimpson

    2010-08-01

    Full Text Available Genome rearrangement often produces chromosomes with two centromeres (dicentrics that are inherently unstable because of bridge formation and breakage during cell division. However, mammalian dicentrics, and particularly those in humans, can be quite stable, usually because one centromere is functionally silenced. Molecular mechanisms of centromere inactivation are poorly understood since there are few systems to experimentally create dicentric human chromosomes. Here, we describe a human cell culture model that enriches for de novo dicentrics. We demonstrate that transient disruption of human telomere structure non-randomly produces dicentric fusions involving acrocentric chromosomes. The induced dicentrics vary in structure near fusion breakpoints and like naturally-occurring dicentrics, exhibit various inter-centromeric distances. Many functional dicentrics persist for months after formation. Even those with distantly spaced centromeres remain functionally dicentric for 20 cell generations. Other dicentrics within the population reflect centromere inactivation. In some cases, centromere inactivation occurs by an apparently epigenetic mechanism. In other dicentrics, the size of the alpha-satellite DNA array associated with CENP-A is reduced compared to the same array before dicentric formation. Extra-chromosomal fragments that contained CENP-A often appear in the same cells as dicentrics. Some of these fragments are derived from the same alpha-satellite DNA array as inactivated centromeres. Our results indicate that dicentric human chromosomes undergo alternative fates after formation. Many retain two active centromeres and are stable through multiple cell divisions. Others undergo centromere inactivation. This event occurs within a broad temporal window and can involve deletion of chromatin that marks the locus as a site for CENP-A maintenance/replenishment.

  17. A Comparison of National Policies on Research Involving Human Subjects to Facilitate Review and Approval of Collaborative Research

    Science.gov (United States)

    2008-11-26

    torture Prohibition on slavery and forced labour Right to liberty and security Right to a fair trial No punishment without law Right to respect...NOT BE TOLERATED. IT IS BOTH A BREACH OF REGULATIONS AND UNETHICAL . UNAUTHORIZED RESEARCH MAY THEREFORE BE SUBJECT TO INVESTIGATION AND

  18. Cooperative research for human factors review of advanced control rooms

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Jung Woon; Park, Jae Chang; Lee, Yong Hee; Oh, In Seok; Lee, Hyun Chul

    2000-12-01

    This project has been performed as cooperative research between KAERI and USNRC. Human factors issues related to soft controls, which is one of key features of advanced HSI, are identified in this project. The issues are analyzed for the evaluation approaches in either experimental or analytical ways. Also, issues requiring additional researches for the evaluation of advanced HSI are identified in the areas of advanced information systems design, computer-based procedure systems, soft controls, human systems interface and plant modernization process, and maintainability of digital systems. The issues are analyzed to discriminate the urgency of researches on it to high, medium, and low levels in consideration of advanced HSI development status in Korea, and some of the issues that can be handled by experimental researches are identified. Additionally, an experimental study is performed to compare operator's performance on human error detection in advanced control rooms vs. in conventional control rooms. It is found that advanced control rooms have several design characteristics hindering operator's error detection performance compared to conventional control rooms.

  19. Cooperative research for human factors review of advanced control rooms

    International Nuclear Information System (INIS)

    Lee, Jung Woon; Park, Jae Chang; Lee, Yong Hee; Oh, In Seok; Lee, Hyun Chul

    2000-12-01

    This project has been performed as cooperative research between KAERI and USNRC. Human factors issues related to soft controls, which is one of key features of advanced HSI, are identified in this project. The issues are analyzed for the evaluation approaches in either experimental or analytical ways. Also, issues requiring additional researches for the evaluation of advanced HSI are identified in the areas of advanced information systems design, computer-based procedure systems, soft controls, human systems interface and plant modernization process, and maintainability of digital systems. The issues are analyzed to discriminate the urgency of researches on it to high, medium, and low levels in consideration of advanced HSI development status in Korea, and some of the issues that can be handled by experimental researches are identified. Additionally, an experimental study is performed to compare operator's performance on human error detection in advanced control rooms vs. in conventional control rooms. It is found that advanced control rooms have several design characteristics hindering operator's error detection performance compared to conventional control rooms

  20. Human genome program report. Part 2, 1996 research abstracts

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1997-11-01

    This report contains Part 2 of a two-part report to reflect research and progress in the US Department of Energy Human Genome Program from 1994 through 1996, with specified updates made just before publication. Part 2 consists of 1996 research abstracts. Attention is focused on the following: sequencing; mapping; informatics; ethical, legal, and social issues; infrastructure; and small business innovation research.

  1. Clathrin- and caveolin-independent entry of human papillomavirus type 16--involvement of tetraspanin-enriched microdomains (TEMs).

    Science.gov (United States)

    Spoden, Gilles; Freitag, Kirsten; Husmann, Matthias; Boller, Klaus; Sapp, Martin; Lambert, Carsten; Florin, Luise

    2008-10-02

    Infectious entry of human papillomaviruses into their host cells is an important step in the viral life cycle. For cell binding these viruses use proteoglycans as initial attachment sites. Subsequent transfer to a secondary receptor molecule seems to be involved in virus uptake. Depending on the papillomavirus subtype, it has been reported that entry occurs by clathrin- or caveolin-mediated mechanisms. Regarding human papillomavirus type 16 (HPV16), the primary etiologic agent for development of cervical cancer, clathrin-mediated endocytosis was described as infectious entry pathway. Using immunofluorescence and infection studies we show in contrast to published data that infectious entry of HPV16 occurs in a clathrin- and caveolin-independent manner. Inhibition of clathrin- and caveolin/raft-dependent endocytic pathways by dominant-negative mutants and siRNA-mediated knockdown, as well as inhibition of dynamin function, did not impair infection. Rather, we provide evidence for involvement of tetraspanin-enriched microdomains (TEMs) in HPV16 endocytosis. Following cell attachment, HPV16 particles colocalized with the tetraspanins CD63 and CD151 on the cell surface. Notably, tetraspanin-specific antibodies and siRNA inhibited HPV16 cell entry and infection, confirming the importance of TEMs for infectious endocytosis of HPV16. Tetraspanins fulfill various roles in the life cycle of a number of important viral pathogens, including human immunodeficiency virus (HIV) and hepatitis C virus (HCV). However, their involvement in endocytosis of viral particles has not been proven. Our data indicate TEMs as a novel clathrin- and caveolin-independent invasion route for viral pathogens and especially HPV16.

  2. Islamic movement and human rights: Pertubuhan Jamaah Islah Malaysia’s involvement in the “Abolish Internal Security Act Movement,” 2000-2012

    Directory of Open Access Journals (Sweden)

    Maszlee Malik

    2014-12-01

    Full Text Available Human rights has been acknowledged as one of the essential characteristics of good governance. Abuse of human rights is strongly associated with bad governance, which is believed by many to be a serious impediment to development and sustainable growth. Despite the active participations of Islamic movements in many parts of the political world, very little is known of their involvement in advocating human rights issues as part of their struggle for power. Nevertheless, as an Islamic movement and an Islamic revivalism actor in Malaysia, Pertubuhan Jamaah Islah Malaysia (JIM has shown otherwise. JIM has resembled a different attitude towards the issue of human rights that they believe as an integrated and pertinent composition of good governance. By scrutinising their political activities and discourse since 2000, it becomes clear that JIM has been actively engaged in good governance and human rights issues, especially those that relate to the political rights of citizens through its involvement in the Abolish Internal Security Act (ISA Movement (Gerakan Mansuhkan ISA. This paper examines JIM’s involvement in human rights issues with a special focus on its active and leading role in calling for the abolishment of the Internal Security Act (ISA.

  3. Research and Development. Annual Report 2000

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    2001-07-01

    This report discusses the research and development activities in which NVE has been involved in 2000. These activities fall into three categories: watercourse research, hydrological research and energy related research. The HYDRA research programme, which studied flooding and human intervention, is discussed in particular. The report includes a list of research and development reports that were published in 2000.

  4. Genes involved in immunity and apoptosis are associated with human presbycusis based on microarray analysis.

    Science.gov (United States)

    Dong, Yang; Li, Ming; Liu, Puzhao; Song, Haiyan; Zhao, Yuping; Shi, Jianrong

    2014-06-01

    Genes involved in immunity and apoptosis were associated with human presbycusis. CCR3 and GILZ played an important role in the pathogenesis of presbycusis, probably through regulating chemokine receptor, T-cell apoptosis, or T-cell activation pathways. To identify genes associated with human presbycusis and explore the molecular mechanism of presbycusis. Hearing function was tested by pure-tone audiometry. Microarray analysis was performed to identify presbycusis-correlated genes by Illumina Human-6 BeadChip using the peripheral blood samples of subjects. To identify biological process categories and pathways associated with presbycusis-correlated genes, bioinformatics analysis was carried out by Gene Ontology Tree Machine (GOTM) and database for annotation, visualization, and integrated discovery (DAVID). Quantitative RT-PCR (qRT-PCR) was used to validate the microarray data. Microarray analysis identified 469 up-regulated genes and 323 down-regulated genes. Both the dominant biological processes by Gene Ontology (GO) analysis and the enriched pathways by Kyoto encyclopedia of genes and genomes (KEGG) and BIOCARTA showed that genes involved in immunity and apoptosis were associated with presbycusis. In addition, CCR3, GILZ, CXCL10, and CX3CR1 genes showed consistent difference between groups for both the gene chip and qRT-PCR data. The differences of CCR3 and GILZ between presbycusis patients and controls were statistically significant (p < 0.05).

  5. Forced migrants involved in setting the agenda and designing research to reduce impacts of complex emergencies: combining Swarm with patient and public involvement.

    Science.gov (United States)

    Brainard, Julii Suzanne; Al Assaf, Enana; Omasete, Judith; Leach, Steve; Hammer, Charlotte C; Hunter, Paul R

    2017-01-01

    The UK's National Institute for Health Research (NIHR) Health Protection Research Unit in Emergency Preparedness and Response was asked to undertake research on how to reduce the impact of complex national/international emergencies on public health. How to focus the research and decide on priority topics was challenging, given the nature of complex events. Using a type of structured brain-storming, the researchers identified the ongoing UK, European and international migration crisis as both complex and worthy of deeper research. To further focus the research, two representatives of forced migrant communities were invited to join the project team as patient and public (PPI) representatives. They attended regular project meetings, insightfully contributed to and advised on practical aspects of potential research areas. The representatives identified cultural obstacles and community needs and helped choose the final research study design, which was to interview forced migrants about their strategies to build emotional resilience and prevent mental illness. The representatives also helped design recruitment documents, and undertake recruitment and interviewer training. Many events with wide-ranging negative health impacts are notable for complexity: lack of predictability, non-linear feedback mechanisms and unexpected consequences. A multi-disciplinary research team was tasked with reducing the public health impacts from complex events, but without a pre-specified topic area or research design. This report describes using patient and public involvement within an adaptable but structured development process to set research objectives and aspects of implementation. An agile adaptive development approach, sometimes described as swarm , was used to identify possible research areas. Swarm is meant to quickly identify strengths and weaknesses of any candidate project, to accelerate early failure before resources are invested. When aspects of the European migration crisis

  6. Ethical dilemmas in malaria vector research in Africa: Making the ...

    African Journals Online (AJOL)

    Malaria vector research presents several dilemmas relating to the various ways in which humans are used in the malaria vector research enterprise. A review of the past and present practices reveals much about the prevailing attitudes and assumptions with regard to the ethical conduct of research involving humans.

  7. Teaching Qualitative Research for Human Services Students: A Three-Phase Model

    Science.gov (United States)

    Goussinsky, Ruhama; Reshef, Arie; Yanay-Ventura, Galit; Yassour-Borochowitz, Dalit

    2011-01-01

    Qualitative research is an inherent part of the human services profession, since it emphasizes the great and multifaceted complexity characterizing human experience and the sociocultural context in which humans act. In the department of human services at Emek Yezreel College, Israel, we have developed a three-phase model to ensure a relatively…

  8. Use of Laboratory Animals in Biomedical and Behavioral Research.

    Science.gov (United States)

    Ministry of Education, Addis Ababa (Ethiopia).

    The use of animals in scientific research has been a controversial issue for over a hundred years. Research with animals has saved human lives, lessened human suffering, and advanced scientific understanding, yet that same research can cause pain and distress for the animals involved and may result in their death. It is hardly surprising that…

  9. Crowds for Clouds : Recent Trends in Humanities Research Infrastructures

    NARCIS (Netherlands)

    Kristel, Conny; Blanke, Tobias; Romary, Laurent; Benardou, Agiati; Champion, Erik; Dallas, Costis; Hughes, Lorna

    2017-01-01

    Humanities have convincingly argued that they need transnational research opportunities and through the digital transformation of their disciplines also have the means to proceed with it on an up to now unknown scale. The digital transformation of research and its resources means that many of the

  10. The Impact and Future of Arts and Humanities Research

    NARCIS (Netherlands)

    Benneworth, Paul Stephen; Gulbrandsen, Magnus; Hazelkorn, Ellen

    2016-01-01

    Drawing on original international research by a cross-European social science team, this book makes an important contribution to the discussion about the future of arts and humanities research. It explores the responses of these fields to the growing range of questions being asked about the value,

  11. Original Research Human papillomavirus in head and neck ...

    African Journals Online (AJOL)

    2017 The College of Medicine and the Medical Association of Malawi. This work is ... Original Research. Human ... simultaneous evaluation of other risk factors including HIV ..... increased HNSCC compared to HIV-negative people.18,19.

  12. 40 CFR 26.1303 - Submission of information pertaining to ethical conduct of completed human research.

    Science.gov (United States)

    2010-07-01

    ... ethical conduct of completed human research. 26.1303 Section 26.1303 Protection of Environment... on the Ethical Conduct of Completed Human Research § 26.1303 Submission of information pertaining to ethical conduct of completed human research. Any person who submits to EPA data derived from human...

  13. A review of over three decades of research on cat-human and human-cat interactions and relationships.

    Science.gov (United States)

    Turner, Dennis C

    2017-08-01

    This review article covers research conducted over the last three decades on cat-human and human-cat interactions and relationships, especially from an ethological point of view. It includes findings on cat-cat and cat-human communication, cat personalities and cat-owner personalities, the effects of cats on humans, and problems caused by cats. Copyright © 2017 Elsevier B.V. All rights reserved.

  14. Melatonin synthesis in the human ciliary body triggered by TRPV4 activation: Involvement of AANAT phosphorylation.

    Science.gov (United States)

    Alkozi, Hanan Awad; Perez de Lara, María J; Pintor, Jesús

    2017-09-01

    Melatonin is a substance synthesized in the pineal gland as well as in other organs. This substance is involved in many ocular functions, giving its synthesis in numerous eye structures. Melatonin is synthesized from serotonin through two enzymes, the first limiting step into the synthesis of melatonin being aralkylamine N-acetyltransferase (AANAT). In this current study, AANAT phosphorylation after the activation of TRPV4 was studied using human non-pigmented epithelial ciliary body cells. Firstly, it was necessary to determine the adequate time and dose of the TRPV4 agonist GSK1016790A to reach the maximal phosphorylation of AANAT. An increase of 72% was observed after 5 min incubation with 10 nM GSK (**p melatonin synthesis. The involvement of a TRPV4 channel in melatonin synthesis was verified by antagonist and siRNA studies as a previous step to studying intracellular signalling. Studies performed on the second messengers involved in GSK induced AANAT phosphorylation were carried out by inhibiting several pathways. In conclusion, the activation of calmodulin and calmodulin-dependent protein kinase II was confirmed, as shown by the cascade seen in AANAT phosphorylation (***p melatonin levels. In conclusion, the activation of a TRPV4 present in human ciliary body epithelial cells produced an increase in AANAT phosphorylation and a further melatonin increase by a mechanism in which Ca-calmodulin and the calmodulin-dependent protein kinase II are involved. Copyright © 2017 Elsevier Ltd. All rights reserved.

  15. How informative is the mouse for human gut microbiota research?

    Science.gov (United States)

    Nguyen, Thi Loan Anh; Vieira-Silva, Sara; Liston, Adrian; Raes, Jeroen

    2015-01-01

    The microbiota of the human gut is gaining broad attention owing to its association with a wide range of diseases, ranging from metabolic disorders (e.g. obesity and type 2 diabetes) to autoimmune diseases (such as inflammatory bowel disease and type 1 diabetes), cancer and even neurodevelopmental disorders (e.g. autism). Having been increasingly used in biomedical research, mice have become the model of choice for most studies in this emerging field. Mouse models allow perturbations in gut microbiota to be studied in a controlled experimental setup, and thus help in assessing causality of the complex host-microbiota interactions and in developing mechanistic hypotheses. However, pitfalls should be considered when translating gut microbiome research results from mouse models to humans. In this Special Article, we discuss the intrinsic similarities and differences that exist between the two systems, and compare the human and murine core gut microbiota based on a meta-analysis of currently available datasets. Finally, we discuss the external factors that influence the capability of mouse models to recapitulate the gut microbiota shifts associated with human diseases, and investigate which alternative model systems exist for gut microbiota research. © 2015. Published by The Company of Biologists Ltd.

  16. 75 FR 8085 - National Institutes of Health Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-02-23

    ... Health Guidelines for Human Stem Cell Research SUMMARY: The National Institutes of Health (NIH) is requesting public comment on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). On July 7, 2009, NIH...

  17. 75 FR 13137 - National Institutes of Health Guidelines for Human Stem Cell Research

    Science.gov (United States)

    2010-03-18

    ... Health Guidelines for Human Stem Cell Research SUMMARY: The National Institutes of Health (NIH) is extending the public comment period on a revision to the definition of human embryonic stem cells (hESCs) in the ``National Institutes of Health Guidelines for Human Stem Cell Research'' (Guidelines). Due to a...

  18. Research on human placenta-derived mesenchymal stem cells ...

    African Journals Online (AJOL)

    Research on human placenta-derived mesenchymal stem cells transfected with pIRES2-EGFP-VEGF165 using liposome. ... African Journal of Biotechnology. Journal Home · ABOUT THIS JOURNAL · Advanced Search · Current Issue ...

  19. Considerations of Human Factors in the Design and Operation of Research Reactors

    International Nuclear Information System (INIS)

    Shokr, A.M.

    2015-01-01

    The feedback from the severe accidents occurred at nuclear power plants showed that safety of nuclear installations does not depend only on technical matters but also on human performance. Human errors can initiate an event or can make , by intervention, the event consequences worse. Human factors are of a particular importance for research reactors since the status of these facilities change frequently and the operators have an easy access to the reactor core and to the associated experimental facilities. This paper discusses the experience with human factors and their impact on the safety of research reactors and application of technical and administrative provisions to address these factors in the design and operation phases of research reactors for continuous improvements in safety and performance of these facilities

  20. Metaphysical and ethical perspectives on creating animal-human chimeras.

    Science.gov (United States)

    Eberl, Jason T; Ballard, Rebecca A

    2009-10-01

    This paper addresses several questions related to the nature, production, and use of animal-human (a-h) chimeras. At the heart of the issue is whether certain types of a-h chimeras should be brought into existence, and, if they are, how we should treat such creatures. In our current research environment, we recognize a dichotomy between research involving nonhuman animal subjects and research involving human subjects, and the classification of a research protocol into one of these categories will trigger different ethical standards as to the moral permissibility of the research in question. Are a-h chimeras entitled to the more restrictive and protective ethical standards applied to human research subjects? We elucidate an Aristotelian-Thomistic metaphysical framework in which to argue how such chimeras ought to be defined ontologically. We then examine when the creation of, and experimentation upon, certain types of a-h chimeras may be morally permissible.

  1. Possible Anandamide and Palmitoylethanolamide involvement in human stroke

    Directory of Open Access Journals (Sweden)

    Pizzolato Gilberto

    2010-05-01

    Full Text Available Abstract Background Endocannabinoids (eCBs are ubiquitous lipid mediators that act on specific (CB1, CB2 and non-specific (TRPV1, PPAR receptors. Despite many experimental animal studies proved eCB involvement in the pathogenesis of stroke, such evidence is still lacking in human patients. Our aim was to determine eCB peripheral levels in acute stroke patients and evaluate their relationship with clinical disability and stroke volume. Methods A cohort of ten patients with a first acute (within six hours since symptoms onset ischemic stroke and a group of eight age- and sex-matched normal subjects were included. Groups were also matched for metabolic profile. All subjects underwent a blood sample collection for anandamide (AEA, 2-arachidonoylglycerol (2-AG and palmitoylethanolamide (PEA measurement; blood sampling was repeated in patients on admission (T0, at 6 (T1 and 18 hours (T2 thereafter. Patients neurological impairment was assessed using NIHSS and Fugl-Meyer Scale arm subitem (FMSa; stroke volume was determined on 48 h follow-up brain CT scans. Blood samples were analyzed by liquid chromatography-atmospheric pressure chemical ionization-mass spectrometry. Results 1T0 AEA levels were significantly higher in stroke patients compared to controls. 2A significant inverse correlation between T0 AEA levels and FMSa score was found. Moreover a positive correlation between T0 AEA levels and stroke volume were found in stroke patients. T0 PEA levels in stroke patients were not significantly different from the control group, but showed a significant correlation with the NIHSS scores. T0 2-AG levels were lower in stroke patients compared to controls, but such difference did not reach the significance threshold. Conclusions This is the first demonstration of elevated peripheral AEA levels in acute stroke patients. In agreement with previous murine studies, we found a significant relationship between AEA or PEA levels and neurological involvement, such

  2. Governing the postmortem procurement of human body material for research.

    Science.gov (United States)

    Van Assche, Kristof; Capitaine, Laura; Pennings, Guido; Sterckx, Sigrid

    2015-03-01

    Human body material removed post mortem is a particularly valuable resource for research. Considering the efforts that are currently being made to study the biochemical processes and possible genetic causes that underlie cancer and cardiovascular and neurodegenerative diseases, it is likely that this type of research will continue to gain in importance. However, post mortem procurement of human body material for research raises specific ethical concerns, more in particular with regard to the consent of the research participant. In this paper, we attempt to determine which consent regime should govern the post mortem procurement of body material for research. In order to do so, we assess the various arguments that could be put forward in support of a duty to make body material available for research purposes after death. We argue that this duty does in practice not support conscription but is sufficiently strong to defend a policy of presumed rather than explicit consent.

  3. A Systematic Review of Mixed Methods Research on Human Factors and Ergonomics in Health Care

    Science.gov (United States)

    Carayon, Pascale; Kianfar, Sarah; Li, Yaqiong; Xie, Anping; Alyousef, Bashar; Wooldridge, Abigail

    2016-01-01

    This systematic literature review provides information on the use of mixed methods research in human factors and ergonomics (HFE) research in health care. Using the PRISMA methodology, we searched four databases (PubMed, PsycInfo, Web of Science, and Engineering Village) for studies that met the following inclusion criteria: (1) field study in health care, (2) mixing of qualitative and quantitative data, (3) HFE issues, and (4) empirical evidence. Using an iterative and collaborative process supported by a structured data collection form, the six authors identified a total of 58 studies that primarily address HFE issues in health information technology (e.g., usability) and in the work of healthcare workers. About two-thirds of the mixed methods studies used the convergent parallel study design where quantitative and qualitative data were collected simultaneously. A variety of methods were used for collecting data, including interview, survey and observation. The most frequent combination involved interview for qualitative data and survey for quantitative data. The use of mixed methods in healthcare HFE research has increased over time. However, increasing attention should be paid to the formal literature on mixed methods research to enhance the depth and breadth of this research. PMID:26154228

  4. Enhanced/Synthetic Vision Systems - Human factors research and implications for future systems

    Science.gov (United States)

    Foyle, David C.; Ahumada, Albert J.; Larimer, James; Sweet, Barbara T.

    1992-01-01

    This paper reviews recent human factors research studies conducted in the Aerospace Human Factors Research Division at NASA Ames Research Center related to the development and usage of Enhanced or Synthetic Vision Systems. Research discussed includes studies of field of view (FOV), representational differences of infrared (IR) imagery, head-up display (HUD) symbology, HUD advanced concept designs, sensor fusion, and sensor/database fusion and evaluation. Implications for the design and usage of Enhanced or Synthetic Vision Systems are discussed.

  5. Book Review: Current Issues in International Human Resource Management and Strategy Research

    DEFF Research Database (Denmark)

    Gretzinger, Susanne

    2009-01-01

    The article reviews the book "Current Issues in International Human Resource Management and Strategy Research," edited by Marion Festing and Susanne Royer.......The article reviews the book "Current Issues in International Human Resource Management and Strategy Research," edited by Marion Festing and Susanne Royer....

  6. Brain regions involved in observing and trying to interpret dog behaviour.

    Science.gov (United States)

    Desmet, Charlotte; van der Wiel, Alko; Brass, Marcel

    2017-01-01

    Humans and dogs have interacted for millennia. As a result, humans (and especially dog owners) sometimes try to interpret dog behaviour. While there is extensive research on the brain regions that are involved in mentalizing about other peoples' behaviour, surprisingly little is known of whether we use these same brain regions to mentalize about animal behaviour. In this fMRI study we investigate whether brain regions involved in mentalizing about human behaviour are also engaged when observing dog behaviour. Here we show that these brain regions are more engaged when observing dog behaviour that is difficult to interpret compared to dog behaviour that is easy to interpret. Interestingly, these results were not only obtained when participants were instructed to infer reasons for the behaviour but also when they passively viewed the behaviour, indicating that these brain regions are activated by spontaneous mentalizing processes.

  7. Coordination of International Risk-Reduction Investigations by the Multilateral Human Research Panel for Exploration

    Science.gov (United States)

    Charles, John B.; Bogomolov, Valery V.

    2015-01-01

    Effective use of the unique capabilities of the International Space Station (ISS) for risk reduction on future deep space missions involves preliminary work in analog environments to identify and evaluate the most promising techniques, interventions and treatments. This entails a consolidated multinational approach to biomedical research both on ISS and in ground analogs. The Multilateral Human Research Panel for Exploration (MHRPE) was chartered by the five ISS partners to recommend the best combination of partner investigations on ISS for risk reduction in the relatively short time available for ISS utilization. MHRPE will also make recommendations to funding agencies for appropriate preparatory analog work. In 2011, NASA's Human Research Program (HRP) and the Institute of Biomedical Problems (IBMP) of the Russian Academy of Science, acting for MHRPE, developed a joint US-Russian biomedical program for the 2015 one-year ISS mission (1YM) of American and Russian crewmembers. This was to evaluate the possibilities for multilateral research on ISS. An overlapping list of 16 HRP, 9 IBMP, 3 Japanese, 3 European and 1 Canadian investigations were selected to address risk-reduction goals in 7 categories: Functional Performance, Behavioral Health, Visual Impairment, Metabolism, Physical Capacity, Microbial and Human Factors. MHRPE intends to build on this bilateral foundation to recommend more fully-integrated multilateral investigations on future ISS missions commencing after the 1YM. MHRPE has also endorsed an on-going program of coordinated research on 6-month, one-year and 6-week missions ISS expeditions that is now under consideration by ISS managers. Preparatory work for these missions will require coordinated and collaborative campaigns especially in the psychological and psychosocial areas using analog isolation facilities in Houston, Köln and Moscow, and possibly elsewhere. The multilateral Human Analogs research working group (HANA) is the focal point of those

  8. Process error rates in general research applications to the Human ...

    African Journals Online (AJOL)

    Objective. To examine process error rates in applications for ethics clearance of health research. Methods. Minutes of 586 general research applications made to a human health research ethics committee (HREC) from April 2008 to March 2009 were examined. Rates of approval were calculated and reasons for requiring ...

  9. FAA airborne data link human factors research plan

    Science.gov (United States)

    1993-07-01

    This report contains a five-year plan to perform research of human factors issues and topics : related to Data Link implementations in general aviation and transport category aircraft. : Elements such as resource allocation and management and coordin...

  10. 76 FR 65204 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-10-20

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

  11. 77 FR 12604 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2012-03-01

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... clearly unwarranted invasion of personal privacy. >Name of Committee: National Human Genome Research... review and evaluate contract proposals. Place: National Human Genome Reseach Institute, 5635 Fishers Lane...

  12. 76 FR 28056 - National Human Genome Research Institute; Notice of Closed Meetings

    Science.gov (United States)

    2011-05-13

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

  13. 78 FR 68856 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-11-15

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

  14. A Research Roadmap for Computation-Based Human Reliability Analysis

    Energy Technology Data Exchange (ETDEWEB)

    Boring, Ronald [Idaho National Lab. (INL), Idaho Falls, ID (United States); Mandelli, Diego [Idaho National Lab. (INL), Idaho Falls, ID (United States); Joe, Jeffrey [Idaho National Lab. (INL), Idaho Falls, ID (United States); Smith, Curtis [Idaho National Lab. (INL), Idaho Falls, ID (United States); Groth, Katrina [Sandia National Lab. (SNL-NM), Albuquerque, NM (United States)

    2015-08-01

    The United States (U.S.) Department of Energy (DOE) is sponsoring research through the Light Water Reactor Sustainability (LWRS) program to extend the life of the currently operating fleet of commercial nuclear power plants. The Risk Informed Safety Margin Characterization (RISMC) research pathway within LWRS looks at ways to maintain and improve the safety margins of these plants. The RISMC pathway includes significant developments in the area of thermalhydraulics code modeling and the development of tools to facilitate dynamic probabilistic risk assessment (PRA). PRA is primarily concerned with the risk of hardware systems at the plant; yet, hardware reliability is often secondary in overall risk significance to human errors that can trigger or compound undesirable events at the plant. This report highlights ongoing efforts to develop a computation-based approach to human reliability analysis (HRA). This computation-based approach differs from existing static and dynamic HRA approaches in that it: (i) interfaces with a dynamic computation engine that includes a full scope plant model, and (ii) interfaces with a PRA software toolset. The computation-based HRA approach presented in this report is called the Human Unimodels for Nuclear Technology to Enhance Reliability (HUNTER) and incorporates in a hybrid fashion elements of existing HRA methods to interface with new computational tools developed under the RISMC pathway. The goal of this research effort is to model human performance more accurately than existing approaches, thereby minimizing modeling uncertainty found in current plant risk models.

  15. A Research Roadmap for Computation-Based Human Reliability Analysis

    International Nuclear Information System (INIS)

    Boring, Ronald; Mandelli, Diego; Joe, Jeffrey; Smith, Curtis; Groth, Katrina

    2015-01-01

    The United States (U.S.) Department of Energy (DOE) is sponsoring research through the Light Water Reactor Sustainability (LWRS) program to extend the life of the currently operating fleet of commercial nuclear power plants. The Risk Informed Safety Margin Characterization (RISMC) research pathway within LWRS looks at ways to maintain and improve the safety margins of these plants. The RISMC pathway includes significant developments in the area of thermalhydraulics code modeling and the development of tools to facilitate dynamic probabilistic risk assessment (PRA). PRA is primarily concerned with the risk of hardware systems at the plant; yet, hardware reliability is often secondary in overall risk significance to human errors that can trigger or compound undesirable events at the plant. This report highlights ongoing efforts to develop a computation-based approach to human reliability analysis (HRA). This computation-based approach differs from existing static and dynamic HRA approaches in that it: (i) interfaces with a dynamic computation engine that includes a full scope plant model, and (ii) interfaces with a PRA software toolset. The computation-based HRA approach presented in this report is called the Human Unimodels for Nuclear Technology to Enhance Reliability (HUNTER) and incorporates in a hybrid fashion elements of existing HRA methods to interface with new computational tools developed under the RISMC pathway. The goal of this research effort is to model human performance more accurately than existing approaches, thereby minimizing modeling uncertainty found in current plant risk models.

  16. Rewards and incentives for the provision of human tissue for research.

    Science.gov (United States)

    Devaney, Sarah

    2014-01-01

    The Nuffield Council on Bioethics' 2011 report, Human Bodies: Donation for Medicine and Research, proposes a system for examining the ethical implications of different types of incentives for the provision of human tissue for use in medicine and research. The cornerstone of this system is the principle of altruism which, the Council recommends, should, where possible, remain the starting point for any such tissue provision. Using the Council's example of ova provision for research as an area in which altruism-based rewards might be departed from, this article argues that such a system has the potential to become inconsistent and unnecessarily complex. It suggests that the outcomes-focussed and motivations-focussed justifications the Council provides do not sit easily within the fast-paced and unpredictable area of biotechnology research. Further, it may undermine the focus on autonomy that is enshrined in the relevant legislation. This article suggests that a fair system for incentivising and rewarding the provision of human tissue in research should be developed, which focuses on elements of this role that are common to all tissue providers.

  17. Legal liabilities in research: early lessons from North America

    Directory of Open Access Journals (Sweden)

    Birenbaum Shelley

    2005-06-01

    Full Text Available Abstract The legal risks associated with health research involving human subjects have been highlighted recently by a number of lawsuits launched against those involved in conducting and evaluating the research. Some of these cases have been fully addressed by the legal system, resulting in judgments that provide some guidance. The vast majority of cases have either settled before going to trial, or have not yet been addressed by the courts, leaving us to wonder what might have been and what guidance future cases may bring. What is striking about the lawsuits that have been commenced is the broad range of individuals/institutions that are named as defendants and the broad range of allegations that are made. The research community should take this early experience as a warning and should reflect carefully on practices where research involving human subjects is concerned.

  18. Challenges of metabolomics in human gut microbiota research.

    Science.gov (United States)

    Smirnov, Kirill S; Maier, Tanja V; Walker, Alesia; Heinzmann, Silke S; Forcisi, Sara; Martinez, Inés; Walter, Jens; Schmitt-Kopplin, Philippe

    2016-08-01

    The review highlights the role of metabolomics in studying human gut microbial metabolism. Microbial communities in our gut exert a multitude of functions with huge impact on human health and disease. Within the meta-omics discipline, gut microbiome is studied by (meta)genomics, (meta)transcriptomics, (meta)proteomics and metabolomics. The goal of metabolomics research applied to fecal samples is to perform their metabolic profiling, to quantify compounds and classes of interest, to characterize small molecules produced by gut microbes. Nuclear magnetic resonance spectroscopy and mass spectrometry are main technologies that are applied in fecal metabolomics. Metabolomics studies have been increasingly used in gut microbiota related research regarding health and disease with main focus on understanding inflammatory bowel diseases. The elucidated metabolites in this field are summarized in this review. We also addressed the main challenges of metabolomics in current and future gut microbiota research. The first challenge reflects the need of adequate analytical tools and pipelines, including sample handling, selection of appropriate equipment, and statistical evaluation to enable meaningful biological interpretation. The second challenge is related to the choice of the right animal model for studies on gut microbiota. We exemplified this using NMR spectroscopy for the investigation of cross-species comparison of fecal metabolite profiles. Finally, we present the problem of variability of human gut microbiota and metabolome that has important consequences on the concepts of personalized nutrition and medicine. Copyright © 2016 Elsevier GmbH. All rights reserved.

  19. Strategies to enhance the impact of research on human resources for health on policy making

    Directory of Open Access Journals (Sweden)

    Taghreed Adam

    2011-06-01

    Full Text Available Despite global recognition of the importance of human resources for health (HRH in achieving health system goals, very little is known about what works, for whom and under what circumstances, especially for low-income and middleincome countries. Several important events and reports have called for increased funding and capacity for HRH research in recent years and several initiatives have started as a result. Progress has been slow, however. The following strategies can be most valuable in ensuring the relevance of the generated evidence for decision making and its contribution to stronger health systems. The first is to promote national processes to set priorities for HRH research with active participation from decision makers. The second is to make conscious efforts to scale up primary research to address priority questions and to develop sustainable mechanisms to evaluate the impact of current or new HRH strategies to feed into the policy making process. The third is to invest in the development of systematic reviews to synthesize available evidence and in the adaptation of the underlying methods to make them more responsive to the type of questions and the nature of research involving HRH issues. The fourth and most important is to consistently use a systems approach in framing and addressing research questions. While a narrow approach may be more attractive and simple, health systems and the problems facing them are not. Increasing the body of evidence that takes into account the complexity of health systems, and particularly human resources for health, will advance knowledge in this area and will make big strides in the quality and usefulness of the generated evidence.

  20. Clathrin- and caveolin-independent entry of human papillomavirus type 16--involvement of tetraspanin-enriched microdomains (TEMs.

    Directory of Open Access Journals (Sweden)

    Gilles Spoden

    Full Text Available BACKGROUND: Infectious entry of human papillomaviruses into their host cells is an important step in the viral life cycle. For cell binding these viruses use proteoglycans as initial attachment sites. Subsequent transfer to a secondary receptor molecule seems to be involved in virus uptake. Depending on the papillomavirus subtype, it has been reported that entry occurs by clathrin- or caveolin-mediated mechanisms. Regarding human papillomavirus type 16 (HPV16, the primary etiologic agent for development of cervical cancer, clathrin-mediated endocytosis was described as infectious entry pathway. METHODOLOGY/PRINCIPAL FINDINGS: Using immunofluorescence and infection studies we show in contrast to published data that infectious entry of HPV16 occurs in a clathrin- and caveolin-independent manner. Inhibition of clathrin- and caveolin/raft-dependent endocytic pathways by dominant-negative mutants and siRNA-mediated knockdown, as well as inhibition of dynamin function, did not impair infection. Rather, we provide evidence for involvement of tetraspanin-enriched microdomains (TEMs in HPV16 endocytosis. Following cell attachment, HPV16 particles colocalized with the tetraspanins CD63 and CD151 on the cell surface. Notably, tetraspanin-specific antibodies and siRNA inhibited HPV16 cell entry and infection, confirming the importance of TEMs for infectious endocytosis of HPV16. CONCLUSIONS/SIGNIFICANCE: Tetraspanins fulfill various roles in the life cycle of a number of important viral pathogens, including human immunodeficiency virus (HIV and hepatitis C virus (HCV. However, their involvement in endocytosis of viral particles has not been proven. Our data indicate TEMs as a novel clathrin- and caveolin-independent invasion route for viral pathogens and especially HPV16.

  1. Creating Learning at Conferences Through Participant Involvement

    DEFF Research Database (Denmark)

    Ravn, Ib; Elsborg, Steen

    as a forum for learning, mutual inspiration and "human co-flourishing." We offer five design principles that specify how conferences may involve participants more and hence increase their learning. In the research and development effort reported here, our team collaborated with conference organizers......The typical conference is brimming with PowerPoint presentations that leave very little time for participant involvement. Students of learning have long abandoned the transfer model that underlies this massive show of one-way communication. We propose an alternative theory of the conference...... in Denmark to introduce a variety of simple learning techniques related to the design principles at thirty real conferences of some 100-200 participants each. We present twelve of these techniques and the data evaluating them and conclude that by spending a fraction of the time at a conference on involving...

  2. Plucked Human Hair Shafts and Biomolecular Medical Research

    Directory of Open Access Journals (Sweden)

    Kevin Schembri

    2013-01-01

    Full Text Available The hair follicle is a skin integument at the boundary between an organism and its immediate environment. The biological role of the human hair follicle has lost some of its ancestral importance. However, an indepth investigation of this miniorgan reveals hidden complexity with huge research potential. An essential consideration when dealing with human research is the awareness of potential harm and thus the absolute need not to harm—a rule aptly qualified by the Latin term “primum non nocere” (first do no harm. The plucked hair shaft offers such advantages. The use of stem cells found in hair follicles cells is gaining momentum in the field of regenerative medicine. Furthermore, current diagnostic and clinical applications of plucked hair follicles include their use as autologous and/or three-dimensional epidermal equivalents, together with their utilization as surrogate tissue in pharmacokinetic and pharmacodynamics studies. Consequently, the use of noninvasive diagnostic procedures on hair follicle shafts, posing as a surrogate molecular model for internal organs in the individual patient for a spectrum of human disease conditions, can possibly become a reality in the near future.

  3. Teaching and Learning Children's Human Rights: A Research Synthesis

    Science.gov (United States)

    Brantefors, Lotta; Quennerstedt, Ann

    2016-01-01

    The study presented in this paper is a research synthesis examining how issues relating to the teaching and learning of children's human rights have been approached in educational research. Drawing theoretically on the European Didaktik tradition, the purpose of the paper is to map and synthesise the educational interest in children's rights…

  4. 77 FR 64816 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-10-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., Human Genome Research, National Institutes of Health, HHS) Dated: October 16, 2012. David Clary, Program... Conference Call). Contact Person: Camilla E. Day, Ph.D., Scientific Review Officer, CIDR, National Human...

  5. 78 FR 11898 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-02-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome....172, Human Genome Research, National Institutes of Health, HHS) Dated: February 13, 2013. David Clary... Conference Call). Contact Person: Camilla E. Day, Ph.D., Scientific Review Officer CIDR, National Human...

  6. 78 FR 77477 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-12-23

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., Human Genome Research, National Institutes of Health, HHS). Dated: December 17, 2013. David Clary... Conference Call). Contact Person: Camilla E. Day, Ph.D., Scientific Review Officer, CIDR, National Human...

  7. 75 FR 52538 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2010-08-26

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

  8. 76 FR 35223 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-06-16

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

  9. Ethical issues in paleopathological and anthropological research experiences.

    Science.gov (United States)

    Licata, Marta; Monza, Francesca

    2017-10-23

    In recent years, archaeologists and anthropologists involved in the study of human remains have had to take into consideration ethical issues, which have come to the fore. The aim of this study is to illustrate the ethical and religious issues involved in relation to the positions of researchers. Ethical issues involve the different study phases of human remains: archaeological excavation, anthropological analysis and, finally, museum display. Osteoarchaeological remains may find a place in museums. However, in recent years, even the display of human remains museum has had to face new important ethical issue involving previously ignored or neglected aspect. The adoption of Native American Grave Protection Act in 1990 in the United States and the Human Tissue Act in 2004 in England, has created new scenarios relating to the storage of human remains in museum. All this caused a series of changes in the study of human remains, but many issues remain open to debate.

  10. Public and patient involvement in quantitative health research: A statistical perspective.

    Science.gov (United States)

    Hannigan, Ailish

    2018-06-19

    The majority of studies included in recent reviews of impact for public and patient involvement (PPI) in health research had a qualitative design. PPI in solely quantitative designs is underexplored, particularly its impact on statistical analysis. Statisticians in practice have a long history of working in both consultative (indirect) and collaborative (direct) roles in health research, yet their perspective on PPI in quantitative health research has never been explicitly examined. To explore the potential and challenges of PPI from a statistical perspective at distinct stages of quantitative research, that is sampling, measurement and statistical analysis, distinguishing between indirect and direct PPI. Statistical analysis is underpinned by having a representative sample, and a collaborative or direct approach to PPI may help achieve that by supporting access to and increasing participation of under-represented groups in the population. Acknowledging and valuing the role of lay knowledge of the context in statistical analysis and in deciding what variables to measure may support collective learning and advance scientific understanding, as evidenced by the use of participatory modelling in other disciplines. A recurring issue for quantitative researchers, which reflects quantitative sampling methods, is the selection and required number of PPI contributors, and this requires further methodological development. Direct approaches to PPI in quantitative health research may potentially increase its impact, but the facilitation and partnership skills required may require further training for all stakeholders, including statisticians. © 2018 The Authors Health Expectations published by John Wiley & Sons Ltd.

  11. Involvement and emancipation of the worker. Action research in a university hospital.

    Science.gov (United States)

    Bolis, Ivan; Brunoro, Claudio; Sznelwar, Laerte Idal

    2012-01-01

    The present action research article is linked to an ergonomics project in a university hospital. The author's proposal is to focus action on the effective worker involvement required for the creation of spaces/mechanisms within organizations where people can enhance cooperation and deliberation on matters relating to work. For this purpose, a committee was introduced to assist in finding problems and solutions directly in work situations, so that workers could experience relative autonomy allowing them to develop procedures and choose tools appropriate to their own real needs. Based on this organizational implementation and on subsequent interviews, the practical results are analyzed and related to employee involvement. One can conclude that workers in all areas of the organization can be active elements for improving working conditions and productivity in companies.

  12. Human dimensions of global change: Toward a research agenda

    International Nuclear Information System (INIS)

    Burton, I.

    1991-01-01

    The Earth's environment is being transformed by human activity. Human activity, in turn, is being affected by these transformations. This interaction is being studied under the aegis of global change in the geosphere-biosphere. The purpose here is to explore the basis for and the substance of a proposed research program focused on the human dimensions of global change. Global warming due to the greenhouse effect, CO2 reduction, environment impacts, land use management, and the removal of greenhouse gases from the atmosphere are among the topics covered

  13. Future human health research directions for the Canadian Northern Contaminants Program

    Science.gov (United States)

    Donaldson, Shawn G.; Curren, Meredith S.; Adlard, Bryan; Provost, Jonathan; Leech, Tara; Tikhonov, Constantine; Feeley, Mark; Tomlinson, Scott; Shearer, Russel

    2013-01-01

    Studies conducted in the mid-1980s and early 1990s demonstrated that persistent organic pollutants (POPs) and metals were reaching the Arctic ecosystem at unexpectedly high levels, many of which had no Arctic or Canadian sources. Epidemiological and toxicological studies in Canada and in other countries have found that these contaminants may pose a risk to human health. The objective of this paper is to provide the foundation for the discussion on future northern human health research under the Northern Contaminants Program (NCP) in Canada. This short discussion of human health priorities will help guide a path forward for future northern human health research in Canada to address on-going and new health concerns related to contaminants exposure in the Canadian Arctic. PMID:24282784

  14. Human performance analysis in the frame of probabilistic safety assessment of research reactors

    International Nuclear Information System (INIS)

    Farcasiu, Mita; Nitoi, Mirela; Apostol, Minodora; Turcu, I.; Florescu, Gh.

    2005-01-01

    Full text: The analysis of operating experience has identified the importance of human performance in reliability and safety of research reactors. In Probabilistic Safety Assessment (PSA) of nuclear facilities, human performance analysis (HPA) is used in order to estimate human error contribution to the failure of system components or functions. HPA is a qualitative and quantitative analysis of human actions identified for error-likely situations or accident-prone situations. Qualitative analysis is used to identify all man-machine interfaces that can lead to an accident, types of human interactions which may mitigate or exacerbate the accident, types of human errors and performance shaping factors. Quantitative analysis is used to develop estimates of human error probability as effects of human performance in reliability and safety. The goal of this paper is to accomplish a HPA in the PSA frame for research reactors. Human error probabilities estimated as results of human actions analysis could be included in system event tree and/or system fault tree. The achieved sensitivity analyses determine human performance sensibility at systematically variations both for dependencies level between human actions and for operator stress level. The necessary information was obtained from operating experience of research reactor TRIGA from INR Pitesti. The required data were obtained from generic data bases. (authors)

  15. Teaching Earth Sciences as an interdisciplinary subject: Novel module design involving research literature

    Science.gov (United States)

    Tong, Vincent C. H.

    2010-05-01

    The study of Earth Sciences requires an interdisciplinary approach as it involves understanding scientific knowledge originating from a wide spectrum of research areas. Not only does it include subjects ranging from, for instance, hydrogeology to deep crustal seismology and from climate science to oceanography, but it also has many direct applications in closely related disciplines such as environmental engineering and natural resources management. While research crossing traditional disciplinary boundaries in geosciences is becoming increasingly common, there is only limited integration of interdisciplinary research in the teaching of the subject. Given that the transition from undergraduate education based on subject modules to postgraduate interdisciplinary research is never easy, such integration is a highly desirable pedagogical approach at both undergraduate and postgraduate levels. My presentation is based on a recent teaching project involving novel design of an undergraduate course. The course is implemented in order to address the synergy between research and teaching (Tong, 2009). This project has been shown to be effective and successful in teaching geosciences undergraduates at the University of London. The module consists of studying core geophysical principles and linking them directly to a selection of recently published research papers in a wide range of interdisciplinary applications. Research reviewing and reporting techniques are systematically developed, practised and fully integrated into teaching of the core scientific theories. A fully-aligned assignment with a feedback website invites the students to reflect on the scientific knowledge and the study skills related to research literature they have acquired in the course. This teaching project has been recognized by a teaching award (http://www.clpd.bbk.ac.uk/staff/BETA). In this presentation, I will discuss how undergraduate teaching with a focus on research literature in Earth Sciences can

  16. Human trafficking and health: a conceptual model to inform policy, intervention and research.

    Science.gov (United States)

    Zimmerman, Cathy; Hossain, Mazeda; Watts, Charlotte

    2011-07-01

    Human trafficking is an international crime renowned for extreme forms of violence against women, men and children. Although trafficking-related violence has been well-documented, the health of trafficked persons has been a largely neglected topic. For people who are trafficked, health risks and consequences may begin before they are recruited into the trafficking process, continue throughout the period of exploitation and persist even after individuals are released. Policy-making, service provision and research often focus narrowly on criminal violations that occur during the period of exploitation, regularly overlooking the health implications of trafficking. Similarly, the public health sector has not yet incorporated human trafficking as a health concern. We present a conceptual model that highlights the migratory and exploitative nature of a multi-staged trafficking process, which includes: 'recruitment', travel-transit', 'exploitation' and 'integration' or 'reintegration', and for some trafficked persons, 'detention' and 're-trafficking' stages. Trafficked persons may suffer from physical, sexual and psychological harm, occupational hazards, legal restrictions and difficulties associated with being marginalised or stigmatised. Researchers and decision-makers will benefit from a theoretical approach that conceptualizes trafficking and health as a multi-staged process of cumulative harm. To address a health risk such as trafficking, which spans geographical boundaries and involves multiple sectors, including immigration and law enforcement, labour, social and health services, interventions must be coordinated between nations and across sectors to promote the protection and recovery of people who are trafficked. Copyright © 2011 Elsevier Ltd. All rights reserved.

  17. Research involving subjects with Alzheimer's disease in Italy: the possible role of family members.

    Science.gov (United States)

    Porteri, Corinna; Petrini, Carlo

    2015-03-04

    Alzheimer's disease is a very common, progressive and still incurable disease. Future possibilities for its cure lie in the promotion of research that will increase our knowledge of the disorder's causes and lead to the discovery of effective remedies. Such research will necessarily involve individuals suffering from Alzheimer's disease. This raises the controversial issue of whether patients with Alzheimer's disease are competent to give their consent for research participation. We discuss the case of subjects with Alzheimer's disease who may have impaired decision-making capacity and who could be involved in research protocols, taking into consideration aspects of the Italian normative framework, which requires a court-appointed legal representative for patients who are not able to give consent and does not recognise the legal value of advance directives. We show that this normative framework risks preventing individuals with Alzheimer's disease from taking part in research and that a new policy that favours research while promoting respect for patients' well-being and rights needs to be implemented. We believe that concerns about the difficulty of obtaining fully valid consent of patients with Alzheimer's disease should not prevent them from participating in clinical trials and benefiting from scientific progress. Therefore, we argue that the requirement for patients to have a legal representative may not be the best solution in all countries and clinical situations, and suggest promoting the role of patients' family members in the decision-making process. In addition, we outline the possible role of advance directives and ethics committees.

  18. 76 FR 66076 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2011-10-25

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... Call). Contact Person: Camilla E. Day, PhD, Scientific Review Officer, CIDR, National Human Genome... Assistance Program Nos. 93.172, Human Genome Research, National Institutes of Health, HHS) Dated: October 19...

  19. 77 FR 50140 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2012-08-20

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome..., Human Genome Research, National Institutes of Health, HHS) Dated: August 13, 2012. Anna Snouffer, Deputy..., Bethesda, MD 20892. Contact Person: Camilla E. Day, Ph.D., Scientific Review Officer, CIDR, National Human...

  20. 78 FR 61851 - National Human Genome Research Institute; Notice of Closed Meeting

    Science.gov (United States)

    2013-10-04

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES National Institutes of Health National Human Genome... unwarranted invasion of personal privacy. Name of Committee: National Human Genome Research Institute Special... a.m. to 4:00 p.m. Agenda: To review and evaluate grant applications. Place: National Human Genome...