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Sample records for polish ethic committees

  1. [About the genesis of the first Polish local research ethics committee].

    Science.gov (United States)

    Paprocka-Lipinska, Anna

    2014-12-01

    From the moment in which the development of medicine became necessary experimental research involving human subjects, the question arose about the ethical limits and limitations of the experiment. The turning point was the year 1947. The Nuremberg Code was formulated after the disclosure of pseudo-medical experiments involving human subjects during the Second World War. In 1964, the medical world accepted the Declaration of Helsinki, which, however, did not prevent abuses and it became necessary to appoint independent ethics committees supervising and enforcing the application of ethics in biomedical experiments. In Poland in the 60's and 70's started a discussion on the ethical rules related to conduct of research involving humans. The initiators of the appointment of bioethics committees were professors of medicine, inspiring experiences of their Western colleagues. It was difficult for reasons of political ideologies to convince the authorities to use the best of western solutions. This paper attempts to describe the circumstances connected with the appointment in 1979 at the Medical University of Gdansk, the first Polish bioethics committee.

  2. Business ethics in ethics committees?

    Science.gov (United States)

    Boyle, P

    1990-01-01

    The "Ethics committees" column in this issue of the Hastings Center Report features an introduction by Cynthia B. Cohen and four brief commentaries on the roles hospital ethics committees may play in the making of institutional and public health care policy in the 1990s. The pros and cons of a broader, more public role for ethics committees in reconciling the business and patient care aspects of health care delivery are debated by Cohen in "Ethics committees as corporate and public policy advocates," and by Philip Boyle in this article. Boyle is an associate for ethical studies at The Hastings Center.

  3. Ethics committees in Croatia

    NARCIS (Netherlands)

    Borovecki, Ana

    2007-01-01

    In this thesis the work of ethics committees in Croatia is being investigated for the first time. The 1997 Law on Health Protection introduced legal standards for the establishment of the so-called 'mixed' type of ethics committees in healthcare institutions. Our study aims to examine whether this

  4. [Ethics in committees].

    Science.gov (United States)

    Hottois, Gilbert

    2007-01-01

    The management of techno-scientific and multicultural societies, open and evolving, can neither be conceived nor carried out on the basis of fundamentalist, essentialist rules that are characteristic of closed, immobile societies. Within a global civilisation, fundamentalisms are only acceptable as individual or community beliefs. Against the background of our civilisation on the chaotic road to globalisation described here, what are the methodological rules for bioethics committees? A first rule concerns the composition of the committees: it must be multidisciplinary and pluralist. The second rule concerns the distinction of types, which is less evident at a time which cultivates postmodernism. The "types" which absolutely must be distinguished are: science, ethics, morals, law, politics. The third rule concerns the concluding procedures. A majority vote procedure after information and limited discussion makes it possible to conclude easily and rapidly. But it generally seems not to be very ethical, especially if it does not allow minorities to have their divergent opinions appear among the conclusions in an explicit argued manner. The "lazy dissensus" must, however also be avoided: it consists in not really engaging the interdisciplinary, pluralist discussion, simply exposing and explaining each position, on the pretext that pluralism is respecting diversity, the freedom to believe, to think and to express oneself either each for himself or in the name of one's community or tradition. This sort of "postmodern" methodology, individualistic and communitarian to an extreme, is precariously balanced in relation to the committee's ethical vocation. It is therefore very important that an ethics committee really engages in discussion and expresses, let's say, a preference for consensus. This preference is the expression of its "ethical" nature: in this word (as in the word "moral", in fact), there is a reference to what is common, to what unites and makes social life

  5. Rebuilding a Research Ethics Committee

    Science.gov (United States)

    Biggs, John S. G.; Marchesi, August

    2013-01-01

    The principal ethics committee in Australia's Capital, Canberra, underwent a major revision in the last three years based on changes debated in the literature. Committee or Board structure varies widely; regulations determining minimum size and membership differ between countries. Issues such as the effectiveness of committee management,…

  6. [Accreditation of Independent Ethics Committees].

    Science.gov (United States)

    Ramiro Avilés, Miguel A

    According to Law 14/2007 and Royal Decree 1090/2015, biomedical research must be assessed by an Research Ethics Committee (REC), which must be accredited as an Research ethics committee for clinical trials involving medicinal products (RECm) if the opinion is issued for a clinical trial involving medicinal products or clinical research with medical devices. The aim of this study is to ascertain how IEC and IECm accreditation is regulated. National and regional legislation governing biomedical research was analysed. No clearly-defined IEC or IECm accreditation procedures exist in the national or regional legislation. Independent Ethics Committees are vital for the development of basic or clinical biomedical research, and they must be accredited by an external body in order to safeguard their independence, multidisciplinary composition and review procedures. Copyright © 2016 SESPAS. Publicado por Elsevier España, S.L.U. All rights reserved.

  7. Enhancing capacity of research ethics review committees

    African Journals Online (AJOL)

    local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards. Methods. The Kenya AIDS ... activities in Kenya, the NCST is responsible for ethical approval of all studies involving human ..... concept of 'ethics committee shopping'. The way forward.

  8. Report of the Ethics Committee, 2015.

    Science.gov (United States)

    2016-01-01

    The Report of the Ethics Committee, 2015, provides information on activities of the Ethics Committee and Ethics Office during that year. In 2015, the Ethics Office and Committee continued their work of adjudication, ethics education, and ethics consultations. The Ethics Committee adopted minor changes to its "Rules and Procedures" to increase the efficiency of the adjudication process. These changes were approved by the APA Board of Directors to become effective on March 1, 2016. The Independent Review Report by David H. Hoffman was released in July. The ethics office director also departed in July, and an interim ethics director was appointed. The process for establishing a Commission on Ethics Processes was also begun. The Commission has the charge of evaluating and recommending changes to the American Psychological Association's current ethics program. Data for adjudication processing in 2015 as well as comparisons to the previous 4 years are provided. (PsycINFO Database Record (c) 2016 APA, all rights reserved).

  9. Evaluation of research ethics committees in Turkey

    OpenAIRE

    Arda, B.

    2000-01-01

    In Turkey, there was no legal regulation of research on human beings until 1993. In that year "the amendment relating to drug researches" was issued. The main objectives of the regulation are to establish a central ethics committee and local ethics committees, and to provide administrative control.There are no compulsory clinical ethics lectures in the medical curriculum, so it is also proposed that research ethics committees (RECs) play a central educational role by helping physicians to be ...

  10. Accreditation of ethics committees: experience of an ethics committee.

    Science.gov (United States)

    Kulkarni, Ragini; Saraiya, Usha

    2015-01-01

    Many ethics committees (ECs) approving clinical trials in India have got themselves registered with the Drugs Controller General of India as per regulatory requirements. However, there is still scope to improve their functioning. Accreditation, which entails adherence to national and international standards, helps an EC to protect the rights, safety and well-being of research participants. The National Institute for Research in Reproductive Health (NIRRH) ethics committee for clinical studies has received recognition, or accreditation, from the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER). An EC receives recognition from SIDCER if it meets five standards related to its structure and composition; adherence to specific policies; completeness of the review process; after-review process; and documentation and archiving. The extent to which these standards have been met is assessed in various ways, such as review of the EC's records, interviews of selected EC members and observation of a full board meeting of the EC. This paper describes the experiences of the NIRRH EC during and after the process of receiving recognition.

  11. Report of the Ethics Committee, 2010

    Science.gov (United States)

    American Psychologist, 2011

    2011-01-01

    In accordance with the bylaws of the American Psychological Association (APA), the Ethics Committee reports regularly to the membership regarding the number and types of ethics matters investigated and the major programs undertaken. In 2010, ethics adjudication, ethics education and consultation, and special projects were activities of the Ethics…

  12. Hospital ethics committees in Israel: structure, function and heterogeneity in the setting of statutory ethics committees

    OpenAIRE

    Wenger, N; Golan, O; Shalev, C; Glick, S

    2002-01-01

    Objectives: Hospital ethics committees increasingly affect medical care worldwide, yet there has been little evaluation of these bodies. Israel has the distinction of having ethics committees legally required by a Patients' Rights Act. We studied the development of ethics committees in this legal environment.

  13. [Polish medical ethics in the period 1945-1980].

    Science.gov (United States)

    Wichrowski, Marek

    2003-01-01

    The purpose of this article is o present that main currents of Polish medical ethics in the years 1945-1980, which the author treats as the 'prehistory' of Poland's contemporary bioethics. The author begins by ascertaining the post-war disappearance of two Polish traditions--that of the Warsaw school of philosopher-physicians (known in the West as the Polish School of Philosophy of Medicine) and the Lwów-Warsaw School of Philosophy. The political system that come into being after 1945 was not conducive to the development of medical ethics, but several clear orientations may be discerned in the utterances of physicians, lawyers, moral technologlans and academic philosophers. The analysis begins with Catholic ethics in its archaic 1950s-vintage form. The author then presents the thinking of ethicians Independent of both the Church and Marxism (the milieu of the journal 'Etyka') as well as the deontological writings of physicians.

  14. Genetic medicine: Polish deontological guidelines and the ethical practice of research studies with children.

    Science.gov (United States)

    Niebrój, Lesław T

    2006-01-01

    The purpose of the article is: (1) to describe deontological guidelines which regulate medical research involving human subjects in Poland, and (2) to clarify the understanding of the fundamental ethical concepts presented in these documents. To do this, two main documents are analysed: (1) the Polish Medical Ethics Code, which was approved by the 7th Extraordinary National Doctors' Convention in September 2003 after a long and difficult process of revision, and (2) the Good Practice in Science, a set of rules concerning scientists, approved by the Committee of Ethics of the Polish Academy of Science in 2001. The pluralism of contemporary ethics and of medical ethics in particular, results in various interpretations of the understanding of the crucial terms used in the deontological statements of these codes. The paper suggests that clarity in the understanding of the terms may be achieved by exploring the 'intellectual' context in which the analysed documents have been appearing and in which they are presently functioning. In order to examine such a context, the following aspects are taken into account: (1) the development of bioethics as a discipline in Poland, (2) international deontological documents which are universally accepted and are in use in Poland, (3) legal regulations regarding medical research involving persons which are currently in force in Poland, and (4) the practice of Polish Institutional Review Boards (IRBs).

  15. 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.

  16. Ethics Committee or Community? Examining the identity of Czech Ethics Committees in the period of transition.

    Science.gov (United States)

    Simek, Jiri; Zamykalova, Lenka; Mesanyova, Marie

    2010-09-01

    Reflecting on a three year long exploratory research of ethics committees in the Czech Republic authors discuss the current role and identity of research ethics committees. The research of Czech ethics committees focused on both self-presentation and self-understanding of ECs members, and how other stakeholders (representatives of the pharmaceutical industry) view them. The exploratory research was based on formal and informal communication with the members of the ethics committees. Members of the research team took part at six regular voluntary meetings of the ethics committees' members, organised by the Forum of Czech Ethics Committees, and at three summer schools of medical ethics. There were realised twenty-five semi-structured interviews as well as six focus group sessions and a participant observation of several regular meetings of three ethics committees. On the grounds of experience from the interviews a simple questionnaire survey was realised among the members of the ethics committees. The ethics committees comprise a community of members working voluntarily, without claims to remuneration or prestige; the unifying goal is protection of subjects of research. The principal working methods are dialogue and agreement. The members of the ethics committees thus, among other things, create an informal community, which can be to a certain extent seen as a Kantian ethical community in a weak sense. The phenomenon of ethics committees can also be described by terms of an epistemic community and a community of practice. These concepts, which are borrowed from other authors and areas, are used as a way how to think of ECs role and identity a bit differently and are meant as a contribution to the current international debate on the topic.

  17. Do ethics committees need a legal framework?

    Science.gov (United States)

    Byk, Christian

    2007-01-01

    The question "do ethics committees need a legal framework" may then raise fundamental discussion in the case of developing countries: will an ethical framework bring them a better capacity to assume their task? And what should this task be if we consider the particularities of clinical research conducted in developing countries?

  18. Let's Not Forget about Clinical Ethics Committees!

    Science.gov (United States)

    Carnevale, Franco A

    2016-01-01

    The aim of this article is to highlight the under-recognized merits of clinical ethics committees (CECs), to help ensure that the development of roles for clinical ethics consultants do not unwittingly compromise the valuable contributions that CECs can continue to provide. I argue that CECs can offer distinctive contributions to the clinical ethics consultation process that can complement and enrich the input provided by a clinical ethics consultant. These distinctions and complementarities should be further examined and developed. This will help to optimize the synergistic contributions that CECs and clinical ethics consultants can make to promote the ethical treatment of patients and their families. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  19. Measuring inconsistency in research ethics committee review.

    Science.gov (United States)

    Trace, Samantha; Kolstoe, Simon Erik

    2017-11-28

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

  20. Measuring inconsistency in research ethics committee review

    OpenAIRE

    Trace, Samantha; Kolstoe, Simon Erik

    2017-01-01

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

  1. Education of ethics committee members: experiences from Croatia.

    NARCIS (Netherlands)

    Borovecki, A.; Have, H.A.M.J. ten; Oreskovic, S.

    2006-01-01

    OBJECTIVES: To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. DESIGN: Before/after cross-sectional study using a self administered questionnaire. SETTING: Educational workshop for members of hospital ethics committees,

  2. Ethical Competence Training for Members on Clinical Ethics Committees (CEC)

    DEFF Research Database (Denmark)

    Knox, Jeanette Bresson Ladegaard

    2017-01-01

    To address the moral questions in patient care and medical practice, Danish hospitals are starting to solicit clinical ethics committees (CEC). As in other places around the world, CECs in Denmark is an interdisciplinary group that includes physicians, nurses, social workers, psychologists, lawyers...... lingering moral quandaries. Thus, the creation of CECs in Denmark has raised the question of qualifications for those who serve on a committee. When the Danish Society of Clinical Ethics was formed in 2012, it was therefore at the forefront of its agenda to establish a training program that would offer...... valuable contributions to the ethical aspect of medical decision making and to serve as an important resource for health care providers, patients and their families. This article describes the history, development and preliminary results of the current training program as well as reflects on future ideas...

  3. Human research ethics committees: examining their roles and practices.

    Science.gov (United States)

    Guillemin, Marilys; Gillam, Lynn; Rosenthal, Doreen; Bolitho, Annie

    2012-07-01

    Considerable time and resources are invested in the ethics review process. We present qualitative data on how human research ethics committee members and health researchers perceive the role and function of the committee. The findings are based on interviews with 34 Australian ethics committee members and 54 health researchers. Although all participants agreed that the primary role of the ethics committee was to protect participants, there was disagreement regarding the additional roles undertaken by committees. Of particular concern were the perceptions from some ethics committee members and researchers that ethics committees were working to protect the institution's interests, as well as being overprotective toward research participants. This has the potential to lead to poor relations and mistrust between ethics committees and researchers.

  4. Jurisdiction of the Medical Ethics Committees.

    Science.gov (United States)

    Voljč, Božidar

    2017-10-01

    Ethical principles of assessing medical research are to the greatest extent defined by the Nuremberg Code, the Declarations of Geneva and Helsinki, and the Oviedo Convention. Pursuant to their directives various national Medical Ethics Committees (MECs) were established which assess the ethics of research according to the risk and benefit ratio of the persons involved. Following the example of other countries, medical ethics committees eventually appeared also in hospitals and some medical and educational institutions around Slovenia. Due to an increased number of ethical challenges, it is of great importance to define the jurisdiction of the Slovenian MECs in order to ensure their coordinated operation. Exclusive jurisdiction of the national MEC includes multicentre and multi-national research, drug research (phases 1-3), high-risk research and research related to doctoral theses. The jurisdiction of the sectoral MECs includes testing the conditions for research, monitoring the execution and overviewing the final reports. A more significant jurisdiction of the sectoral MEC is preserving an ethical environment in their institutions. A network of Slovenian MECs is to be organised in the form of a jurisdiction pyramid where each member has its own obligations and responsibilities and plays an important role in relation to the entire structure.

  5. Collaborative ethics: a standing renal dialysis ethics committee.

    Science.gov (United States)

    Grochowski, E C; Blacksher, E

    2000-10-01

    We describe a unique, award-winning, multidisciplinary, standing committee focused on ethical issues associated with chronic dialysis. The committee was formed as a collaboration between the National Kidney Foundation of Kansas and Western MO affiliate and the Midwest Bioethics Center, Kansas City, MO in June 1995 to serve the local nephrology community. The committee is comprised of experienced nephrologists, dialysis nurses, and social workers, as well as clergy, medical ethicists, and patient representatives. Committee membership has remained relatively stable over the 4 years of its existence, creating a collaborative spirit among members, which is noteworthy because members are otherwise competing with each other for patients. The committee provides education in a variety of forms, from case consultations to organized seminars. We believe this committee is valuable to the care of patients on dialysis in our local community and that similar committees can be created in other affiliates. We can envision a national network of such committees that together could work on issues in ways that serve both the local and national level. Copyright 2000 by the National Kidney Foundation, Inc.

  6. Ethical aspects in tissue research: thematic analysis of ethical statements to the research ethics committee

    Science.gov (United States)

    2012-01-01

    Background Many studies have been published about ethics committees and the clarifications requested about the submitted applications. In Finland, ethics committees require a separate statement on ethical aspects of the research in applications to the ethics committee. However, little is known about how researchers consider the ethical aspects of their own studies. Methods The data were collected from all the applications received by the official regional ethics committee in the Hospital District of Northern Savo during 2004–2009 (n = 688). These included a total of 56 studies involving research on tissue other than blood. The statements by the researchers about the ethics about their own research in these applications were analyzed by thematic content analysis under the following themes: recruitment, informed consent, risks and benefits, confidentiality and societal meaning. Results The researchers tended to describe recruitment and informed consent process very briefly. Usually these descriptions simply stated who the recruiter was and that written consent would be required. There was little information provided on the recruitment situation and on how the study recruiters would be informed. Although most of the studies were clinical, the possibility was hardly ever discussed that patients could fail to distinguish between care and research. Conclusion The written guidelines, available on the webpages of the ethics committee, do not seem to be enough to help researchers achieve this goal. In addition to detailed guidelines for researchers, investigators need to be taught to appreciate the ethical aspects in their own studies. PMID:22873761

  7. [Why to audit to research ethics committees?].

    Science.gov (United States)

    Quiroz, Estela

    2010-09-01

    Ethics committees in biomedical research have the responsibility to ensure the protection of human participants in the studies. In order to improve the quality of their work they must undergo audit procedures commissioned by the sponsors and inspections done by the regulatory authorities. Through these procedures, improvement of their functions should be guaranteed, so they can optimize their tasks and accomplish in the best way the purpose for which they were created.

  8. 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…

  9. Audit Committee Practice in the Polish Listed Stock Companies. Present Situation and Development Perspectives

    Directory of Open Access Journals (Sweden)

    Piotr Szczepankowski

    2012-06-01

    Full Text Available The audit committee is one of the parts of corporate governance mechanism, which is understood as the relationship between corporate managers, directors and the providers of equity, people and institutions who save and invest their capital to earn the return. This study presents survey research results of audit committee activity in Polish public stock companies quoted on the Warsaw Stock Exchange (WSE. The purpose of this paper is to present the audit committee practice in Poland after 2009. The paper shows that the audit committee practice is still the most problematic issue of transitional Polish corporate governance rules. The survey has shown that the corporate needs and its implementation, and communication with listed companies leave a lot of room for improvement. The paper is based on the documents prepared in 2010 by PricewaterhouseCoopers, the Polish Association of Listed Companies and the Polish Institute of Directors.

  10. [Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics].

    Science.gov (United States)

    Valdez-Martínez, Edith; Lifshitz-Guinzberg, Alberto; Medesigo-Micete, José; Bedolla, Miguel

    2008-08-01

    To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and functions. A cross-sectional descriptive study was conducted from January-December 2005. A survey was sent by e-mail to the hospitals and family medicine centers with at 10 practices within the Mexican Institute for Social Security (Instituto Mexicano del Seguro Social) (n=437) and the Institute for Security and Social Services for State Employees (Seguridad y Servicios Sociales de los Trabajadores del Estado) (n=167) and to the Mexican Ministry of Health's most important health care centers (n=15). The following items were analyzed: name of the committee, date of formation, current status, composition, functions, and level of authority. In all, 116 committees were identified, with various names. Of these, 101 (87.1%) were active. The committees were formed from 1985-2006, with a spike occurring in 2004-2005. Of the active committees, 59 (58.4%) were charged with ethical problems/dilemmas related to clinical practice as well as those related to research projects. Of the committee members, 357 (59.0%) held managing positions in the establishment to which the committee pertained; most were medical professionals (71.5%), followed by nursing staff (11.9%). Among the members of the active committees, 77.9% had not received training in ethics. Legal conflicts can be expected, mainly within the organizations whose committees have the authority to determine a course of action. An integrated plan is needed that will set standards for the composition and proceedings of Mexico's ethics committees and the improved training of committee members.

  11. Barriers and challenges in clinical ethics consultations: the experiences of nine clinical ethics committees.

    Science.gov (United States)

    Pedersen, Reidar; Akre, Victoria; Førde, Reidun

    2009-10-01

    Clinical ethics committees have recently been established in nearly all Norwegian hospital trusts. One important task for these committees is clinical ethics consultations. This qualitative study explores significant barriers confronting the ethics committees in providing such consultation services. The interviews with the committees indicate that there is a substantial need for clinical ethics support services and, in general, the committee members expressed a great deal of enthusiasm for the committee work. They also reported, however, that tendencies to evade moral disagreement, conflict, and 'outsiders' are common in the hospitals. Sometimes even the committees comply with some of these tendencies. The committees agree that there is a need to improve their routines and procedures, clarify the committees' profile and field of responsibility, to make the committees well-known, to secure adequate operating conditions, and to develop organizational integration and support. Various strategies to meet these challenges on a local, regional or national level are also explored in this paper.

  12. Knowledge about the research and ethics committee at Makerere ...

    African Journals Online (AJOL)

    EB

    Abstract. Background: All research involving human participants should be reviewed by a competent and independent institutional research and ethics committee. Research conducted at Makerere University College of Health Sciences should be subjected to a rigorous review process by the ethics committee in order to ...

  13. Education of ethics committee members: experiences from Croatia.

    Science.gov (United States)

    Borovecki, A; ten Have, H; Oresković, S

    2006-03-01

    To study knowledge and attitudes of hospital ethics committee members at the first workshop for ethics committees in Croatia. Before/after cross-sectional study using a self administered questionnaire. Educational workshop for members of hospital ethics committees, Zagreb, 2003. Knowledge and attitudes of participants before and after the workshop; everyday functioning of hospital ethics committees. The majority of the respondents came from committees with at least five members. The majority of ethics committees were appointed by the governing bodies of their hospitals. Most committees were founded after the implementation of the law on health protection in 1997. Membership structure (three physicians and two members from other fields) and functions were established on the basis of that law. Analysis of research protocols was the main part of their work. Other important functions-education, case analysis, guidelines formation-were neglected. Members' level of knowledge was not sufficient for the complicated tasks they were supposed to perform. However, it was significantly higher after the workshop. Most respondents felt their knowledge should be improved by additional education. Their views on certain issues and bioethical dilemmas displayed a high level of paternalism and over protectiveness, which did not change after the workshop. The committees developed according to bureaucratic requirements. Furthermore, there are concerns about members' knowledge levels. More efforts need to be made to use education to improve the quality of the work. Additional research is necessary to explore ethics committees' work in Croatia especially in the hospital setting.

  14. \\How Can Clinical Ethics Committees Take on Organizational Ethics? Some Practical Suggestions.

    Science.gov (United States)

    Sabin, James E

    2016-01-01

    Although leaders in the field of ethics have for many years pointed to the crucial role that organizations play in shaping healthcare ethics, organizational ethics remains a relatively undeveloped area of ethics activity. Clinical ethics committees are an important source of potential expertise, but new skills will be required. Clinical ethics committees seeking to extend their purview to organizational issues will have to respond to three challenges-how to gain sanction and support for addressing controversial and sensitive issues, how to develop an acceptable process, and how to make a difference on the ground. The article presents practical suggestions for how clinical ethics committees meet these challenges. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  15. Different views on ethics: how animal ethics is situated in a committee culture.

    Science.gov (United States)

    Ideland, M

    2009-04-01

    Research that includes non-human animal experimentation is fundamentally a dilemmatic enterprise. Humans use other animals in research to improve life for their own species. Ethical principles are established to deal with this dilemma. But despite this ethical apparatus, people who in one way or another work with animal experimentation have to interpret and understand the principles from their individual points of view. In interviews with members of Swedish animal ethics committees, different views on what the term ethics really means were articulated. For one member, the difficult ethical dilemma of animal experimentation is the lack of enriched cages for mice. For another, the ethical problem lies in regulations restraining research. A third member talks about animals' right not to be used for human interests. These different views on "ethics" intersect once a month in the animal ethics committee meetings. There is no consensus on what constitutes the ethical problem that the members should be discussing. Therefore, personal views on what ethics means, and hierarchies among committee members, characterise the meetings. But committee traditions and priorities of interpretation as well are important to the decisions. The author discusses how "ethics" becomes situated and what implications this may have for committees' decisions.

  16. Ethical Evaluation of Mental Health Social Research: Agreement Between Researchers and Ethics Committees.

    Science.gov (United States)

    Mondragón Barrios, Liliana; Guarneros García, Tonatiuh; Jiménez Tapia, Alberto

    2017-07-01

    The objective of this article is to compare various ethical issues considered by social scientists and research ethics committees in the evaluation of mental health social research protocols. We contacted 47 social scientists and 10 members of ethics committees in Mexico with two electronic national surveys that requested information from both groups related to the application of ethical principles in mental health social research. The results showed no significant difference between these groups in the value placed on the ethical issues explored. Based on this finding, we make proposals to strengthen the collaboration between the two groups.

  17. Whose Ethics, Whose Accountability? A Debate about University Research Ethics Committees

    Science.gov (United States)

    Hoecht, Andreas

    2011-01-01

    Research ethics approval procedures and research ethics committees (RECs) are now well-established in most Western Universities. RECs base their judgements on an ethics code that has been developed by the health and biomedical sciences research community and that is widely considered to be universally valid regardless of discipline. On the other…

  18. Enhancing capacity of research ethics review committees in ...

    African Journals Online (AJOL)

    Background. The increased number of clinical trials taking place in developing countries and the complexity of trial protocols mandate that local ethics review committees (ERCs) reviewing them have the capacity to ensure that they are conducted to the highest ethical standards. Methods. The Kenya AIDS Vaccine Initiative ...

  19. The Special Educator and the Hospital Ethics Committee.

    Science.gov (United States)

    Lowenthal, Barbara; And Others

    With the advent of Public Law 99-457, special educators may be expected to observe and/or serve on Hospital Ethics Committees (HECs) in order to better assist families who have seriously ill and handicapped infants and children. Issues considered by such committees include alternative viewpoints on infant euthanasia and their right to life, the…

  20. The untimely death of the UK Donation Ethics Committee.

    Science.gov (United States)

    Shaw, David

    2017-01-01

    This brief report describes the contribution of the UK Donation Ethics Committee to organ donation and transplantation in the UK, and explains why the committee has met an early demise. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  1. Archives of Voivodship Committee of Polish United Workers’ Party in Biała Podlaska

    Directory of Open Access Journals (Sweden)

    Dariusz Magier

    2010-12-01

    Full Text Available Documentation generated by the communist party after World War II constituted the part of Polish archival heritage. However, Party’s archives were not supervised by nationalarchival network. At the beginning they were storehouses of acts, and since 1955 they had been taken over by propaganda sections of voivodship committees of PZPR (Polish United Workers’ Party and later transformed into the archives of voivodship committees of the Party. The task to preserve documentation generated by the structures of the communist party in Poland was subsequently supervised by: Party HistoryInstitute at KC PZPR (Central Committee of Polish United Workers’ Party, Archives of KC PZPR, and since 1971 Central Archives of KC PZPR. Together with the archives of voivodship committees the net with its own regulations, staff and archival methodology was created. This article gives a detailed description of the activity of the organizational unit,that is the archives of the voivodship committee of the communist party. One of the smallest committees existing in Poland, a provincial Voivodship Committee of PZPR in Biała Podlaska, which operated from 1975 to 1990, serves as an example. The article discusses the reporting structure, handing-over, analysis and preservation of acts, means of recording, premises, system of training and control as well as characterizes the role of a supervisor of the Party’s voidovdship committee Archives played in the archives and chancery.

  2. Section of Cybernetics in Mining of Mining Committee of Polish Academy of Sciences - Pro Memoria

    Science.gov (United States)

    Wojaczek, Antoni; Miśkiewicz, Kazimierz

    2017-09-01

    Section of Cybernetics in Mining of Mining Committee of Polish Academy of Science (PAN) has been created by PAN Mining Committee in 1969. It was a section in Mining Committee of PAN, whose operation range included widely understood issues of automation, telecommunication and informatics in mining industry. The main operation method of the Section was to organize the periodic conferences dedicated to issues of control systems in mining. The first conference took place in 1971 in Katowice. Together with new (the current one) term of office of Mining Committee of PAN this Section ceased to exist. The paper presents (pro memoria) over 40 year long conference output of this Section that functioned within the scope of operation of Mining Committee of PAN up to 12th January 2016.

  3. Bridging problems and models in medical ethics: four images of local ethics committees.

    Science.gov (United States)

    Incorvati, G

    In the context of the continuing debate about how ethics committees in Italy should be structured (see Bulletin 160) Professor Incorvati, from the Comitato Nazionale per la Bioetica in Rome, considers four theoretical models of how such committees may be arranged, and why one in particular looks better placed to face the growing ethical problems that are emerging as a result of current developments in medicine.

  4. Confessions of an Ethics Committee Chair

    Science.gov (United States)

    Halse, Christine

    2011-01-01

    This essay examines the possibilities of being/becoming an ethical researcher in the academy. It tackles this task through the lens of an ethics application by Mary [pseudonym], a PhD student in sociology whose research thesis was investigating the reasons why married men with children use prostitutes. Two analyses are offered of Mary's story. The…

  5. Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings

    NARCIS (Netherlands)

    de Jong, Jean Philippe; van Zwieten, Myra C. B.; Willems, Dick L.

    2012-01-01

    Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We

  6. The importance of the training of Ethics Committee members.

    Science.gov (United States)

    Ricci, Giovanna; Cannovo, Nunzia

    2009-12-01

    Research Ethics Committees (RECs) carry out the important task of humanizing clinical trials. While current Italian and international legislation dedicates considerable attention to REC composition, with consensus on several vital guidelines, no such univocal guidelines are available for REC training in Europe. In Italy, the activity of RECs is subject to moral, civil and criminal responsibility, but the issue of their preparation has been addressed only marginally. This article deals with the Italian situation, thus aims at exploring the question of REC training and trying to identify solutions. Committee members need both initial and continuing education and training in research ethics, methodology and governance.

  7. Ethics committees in Italy--a time for change?

    Science.gov (United States)

    Wray, E

    2000-01-01

    The Comitato Nazionale per la Bioetica (CNB) in Italy has recently produced an unprecedented discussion document on the state of ethics committees in Italy, with an invitation to interested parties to comment on proposed changes to their fundamental structure. After this consultation, and taking note of relevant official publications and the most recent national and international literature on the subject, the CNB proposes to produce a final, definitive document that will consider options for the future development of such committees.

  8. IDRC's Advisory Committee on Research Ethics | IDRC ...

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

    ACRE) to guide Centre employees who encounter ethical issues in the research we ... Concern for the welfare of participants: researchers should act to benefit or promote the wellbeing of participants (beneficence) and should do no harm ...

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

    Science.gov (United States)

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

    2016-04-01

    A novel Protocol Ethics Tool Kit ('Ethics Tool Kit') has been developed by a multi-stakeholder group of the Multi-Regional Clinical Trials Center of Brigham and Women's Hospital and Harvard. The purpose of the Ethics Tool Kit is to facilitate effective recognition, consideration and deliberation of critical ethical issues in clinical trial protocols. The Ethics Tool Kit may be used by investigators and sponsors to develop a dedicated Ethics Section within a protocol to improve the consistency and transparency between clinical trial protocols and research ethics committee reviews. It may also streamline ethics review and may facilitate and expedite the review process by anticipating the concerns of ethics committee reviewers. Specific attention was given to issues arising in multinational settings. With the use of this Tool Kit, researchers have the opportunity to address critical research ethics issues proactively, potentially speeding the time and easing the process to final protocol approval. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  10. Early Childhood Special Educators and the Hospital Ethics Committee.

    Science.gov (United States)

    Lowenthal, Barbara

    1989-01-01

    The paper discusses issues of concern to early childhood special educators serving on hospital ethics committees to assist families with seriously ill and handicapped infants in neonatal intensive care units. Issues include infant euthanasia and the right to life, child abuse legislation, and possible effects on families. (Author/JDD)

  11. Current role of research ethics committees in health research in ...

    African Journals Online (AJOL)

    2014-05-01

    May 1, 2014 ... to regulate health research until 2007, when a national regulatory body, the National Health Research Ethics Committee (NHREC), was ... responsibility to submit enough hard copies of their proposals for all members of the ... Most HREC members understood the concepts of autonomy and consent in ...

  12. Payment of research participants: current practice and policies of Irish research ethics committees.

    LENUS (Irish Health Repository)

    Roche, Eric

    2013-09-01

    Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking.

  13. Research Award: Advisory Committee on Research Ethics

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

    IDRC CRDI

    Canada. Candidates should possess: • Demonstrated interest in research ethics in international development or global health. • Knowledge of research for development. • Strong research and analytical skills. • Proficiency in English; French language skills an asset. • Strong verbal and written communication skills.

  14. Ethics creep or governance creep? Challenges for Australian Human Research Ethics Committees (HRECS).

    Science.gov (United States)

    Gorman, Susanna M

    2011-09-01

    Australian Human Research Ethics Committees (HRECs) have to contend with ever-increasing workloads and responsibilities which go well beyond questions of mere ethics. In this article, I shall examine how the roles of HRECs have changed, and show how this is reflected in the iterations of the National Statement on Ethical Conduct in Human Research 2007 (NS). In particular I suggest that the focus of the National Statement has shifted to concentrate on matters of research governance at the expense of research ethics, compounded by its linkage to the Australian Code for the Responsible Conduct of Research (2007) in its most recent iteration. I shall explore some of the challenges this poses for HRECs and institutions and the risks it poses to ensuring that Australian researchers receive clear ethical guidance and review.

  15. 78 FR 48438 - Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2013-08-08

    ...] Pediatric Ethics Subcommittee of the Pediatric Advisory Committee; Notice of Meeting AGENCY: Food and Drug... of Subcommittee: Pediatric Ethics Subcommittee of the Pediatric Advisory Committee. General Function... pediatric ethical issues. Date and Time: The meeting will be held on September 9, 2013, from 8 a.m. to 5:30...

  16. Ethical assessment of research protocols: the experience of the Research Ethics Committee of the Hospital Israelita Albert Einstein (HIAE

    Directory of Open Access Journals (Sweden)

    Sonia Maria Oliveira de Barros

    2005-03-01

    Full Text Available This is a review article on the origin of the ethical analysis ofresearch protocols, the Brazilian and International legislation,including the Research Ethics Committee of Hospital IsraelitaAlbert Einstein. Since 1997, when the Committee was validatedits role has been recognized as that of a consultant and educator,participating on local and national scientific events andcollaborating with researchers in order to improve their projectsand learn to recognize ethical dilemmas in their protocols.

  17. [Ethical justification for human stem cell research. The view of the German Central Ethics Committee for Stem Cell Research].

    Science.gov (United States)

    Siep, L

    2008-09-01

    According to the German Stem Cell Act the Central Ethics Committee for Stem Cell Research (ZES) advices the competent authority (Robert Koch Institute) as to whether an application to import human embryonic stem-cells for research is "ethically justifiable" ("ethisch vertretbar"). The law does indeed specify some conditions of this justification, but without precisely defining them. This article clarifies the committee's understanding of ethically justifiable research. It deals with misunderstandings of the law and problems involved in its application.

  18. Mock Hospital Ethics Committee: An Innovative Simulation to Teach Prelicensure Nursing Students the Complexities of Ethics in Practice.

    Science.gov (United States)

    Hagedorn Wonder, Amy

    Limited opportunities exist for prelicensure nursing students to observe the interprofessional process required to resolve complex ethical cases in practice. Therefore, a mock hospital ethics committee (MHEC) was assembled to teach the application of ethics in practice through simulation. The MHEC meeting is an example of how nursing education and practice can partner to create meaningful learning experiences.

  19. The new system of review by multicentre research ethics committees: prospective study.

    Science.gov (United States)

    Tully, J; Ninis, N; Booy, R; Viner, R

    2000-04-29

    To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. A single multicentre research ethics committee and 125 local ethics committees from six regions of England. Time to reply, time to approval, and number of non-local changes to the application requested. Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims.

  20. An ethics for the living world: operation methods of Animal Ethics Committees in Italy

    Directory of Open Access Journals (Sweden)

    Mariano Martini

    2015-09-01

    Full Text Available INTRODUCTION AND OBJECTIVES. Coinciding with the recent implementation in Italy of the "Directive 2010/63/EU, regarding the protection of animals used for scientific purposes", the Authors would like to analyse the topic of the introduction of ethical committees for animal experimentation in Italy. This paper furthermore aims to underline some critical aspects concerning the actions taken by Italian institutions to comply with the provisions of EU. RESULTS AND DISCUSSION. The implementation of the recent Italian law (Decreto Legislativo n. 26 on 4 March 2014 Implementation of the Directive 2010/63/EU on the protection of animals used for scientific purposes leans towards a restrictive interpretation of the European provisions about composition and responsibilities of "Ethical Committee for Animal Experimentation". In the composition of the bodies mentioned, we note a tendency to restrict the composition to few professional figures contemplated by Italian law, without guaranteeing the independence of each committee; also, an absence of hierarchical relationship between a research institution and his committee is apparent. Moreover, a critical aspect is the lack of decision-making powers of these new organisms in terms of ethical evaluation of protocols and research projects. CONCLUSIONS. What EU legislation imposes on the member states is to set up an animal-welfare body (art. 26. This represents a strong incentive for Italy to follow the steps of many other European Countries, where ad hoc ethical committees have been working for a long time. The proper functioning of these bodies may contribute to guarantee the safety and welfare of the animals inside the laboratories, and to balance the protection of animal life and the interests of research.

  1. Impact of recent regulatory notifications on an institutional ethics committee.

    Science.gov (United States)

    Bhide, Shruti S; Jalgaonkar, Sharmila V; Katkar, Janhavi V; Shetty, Yashashri C; Tripathi, Raakhi K; Marathe, Padmaja A; Thatte, Urmila M

    2016-01-01

    The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.

  2. Ethics Committees in India: Past, present and future

    Science.gov (United States)

    Thatte, Urmila M.; Marathe, Padmaja A.

    2017-01-01

    Following watershed amendments in Schedule Y India's star rose rather rapidly on the clinical research (especially clinical trials) horizon. Just as dramatic was the fall of this empire. At the centre of these events has been the participant and indirectly, the Ethics Committee (EC) that is established primarily to protect this individual. This paper traces the evolution of the concept of ECs in India, examines the current state of these committees in the country and suggests the way forward. The Past: The requirement for an EC to oversee clinical research was first made in the ICMR Policy Statement for Ethics published in 1980 and then again in the Schedule Y (1988). Later, both the Amended Schedule Y (2005) assigned regulatory responsibility on the EC and the ICMR Guidelines (2006) described the functioning of ECs. Several challenges including inadequate formal training, contribution from non-technical members, administrative support as well no SOPs and a heavy workload were identified. In the absence of regulatory oversight of ECs, the introduction of the Clinical Trial Registry - India (CTRI) and self-regulation through voluntary accreditation programs brought a measure of accountability and transparency. The Present: A slew of regulatory reforms led to more than 1000 ECs to be registered with CDSCO although the actual impact on participants' protection and safety of these new regulations still remains to be seen. Way Forward: A method to oversee all ECs, improved functioning of ECs including on site monitoring, central ECs for multicentric studies, the development of metrics to assess the ability of ECs to protect the participant are other ideas for the future. Conclusions: Although ECs in India have evolved from being mere rubber stamps for approval of protocols to efficiently functioning accredited ECs, yet there is much to be done for and by Ethics Committees. PMID:28194334

  3. A new role for psychologists--hospital ethics committees.

    Science.gov (United States)

    Mozdzierz, G J; Snodgrass, R W; DeLeon, P H

    1992-12-01

    Over the past decade psychology has begun to appreciate that it represents more than "merely mental health care" and has become increasingly involved in the generic health care arena. The participation of psychologists in Hospital Ethics Committees (HECs) is presented as a professional activity for which psychologists are particularly well suited. The clinical mission of HECs, the historical importance of ethical considerations to psychology, and the field's specific training and psycho-social expertise suggest valuable contributions that psychologists can make in this particular area. Further, as psychology actively increases its participation in HECs, other professional disciplines outside of the mental health field will systematically have the opportunity to become more familiar with psychology and its clinical and research expertise.

  4. The role of ethics committees and ethics consultation in allocation decisions: a 4-stage process.

    Science.gov (United States)

    Strech, Daniel; Hurst, Samia; Danis, Marion

    2010-09-01

    Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. This article argues for the need for ethics consultation in rationing decisions using empirical data about the status quo and the inherent nature of bedside rationing. Subsequently, it introduces a 4-stage process for establishing and conducting ethics consultation in rationing questions with systematic reference to core elements of procedural justice. Qualitative and quantitative findings show a significant demand for ethics consultation expressed directly by doctors, as well as additional indirect evidence of such a need as indicated by ethically challenging circumstances of inconsistent and structurally disadvantaging rationing decisions. To address this need, we suggest 4 stages for establishing and conducting ethics consultation in rationing questions we recommend: (1) training, (2) identifying actual scarcity-related problems at clinics, (3) supporting decision-making, and (4) evaluation. This process of ethics consultation regarding rationing decisions would facilitate the achievement of several practical goals: (i) encouragement of an awareness and understanding of ethical problems in bedside rationing, (ii) encouragement of achieving efficiency along with rationing, (iii) reinforcement of consistency in inter- and intraindividual decision-making, (iv) encouragement of explicit reflection and justification of the prioritization criteria taken into consideration, (v) improvement in internal (in-house) and external transparency, and (vi) prevention of the misuse of the corresponding consulting structures.

  5. The Role of Ethics Committees and Ethics Consultation in Allocation Decisions

    Science.gov (United States)

    Strech, Daniel; Hurst, Samia; Danis, Marion

    2013-01-01

    Background Decisions about the allocation and rationing of medical interventions likely occur in all health care systems worldwide. So far very little attention has been given to the question of what role ethics consultation and ethics committees could or should play in questions of allocation at the hospital level. Objectives and Methods This article argues for the need for ethics consultation in rationing decisions using empirical data about the status quo and the inherent nature of bedside rationing. Subsequently, it introduces a 4-stage process for establishing and conducting ethics consultation in rationing questions with systematic reference to core elements of procedural justice. Results Qualitative and quantitative findings show a significant demand for ethics consultation expressed directly by doctors, as well as additional indirect evidence of such a need as indicated by ethically challenging circumstances of inconsistent and structurally disadvantaging rationing decisions. To address this need, we suggest 4 stages for establishing and conducting ethics consultation in rationing questions we recommend: (1) training, (2) identifying actual scarcity-related problems at clinics, (3) supporting decision-making, and (4) evaluation. Conclusion This process of ethics consultation regarding rationing decisions would facilitate the achievement of several practical goals: (i) encouragement of an awareness and understanding of ethical problems in bedside rationing, (ii) encouragement of achieving efficiency along with rationing, (iii) reinforcement of consistency in inter- and intraindvidual decision-making, (iv) encouragement of explicit reflection and justification of the prioritization criteria taken into consideration, (v) improvement in internal (in-house) and external transparency, and (vi) prevention of the misuse of the corresponding consulting structures. PMID:20706163

  6. The role of the child and adolescent psychiatrist on health care institutional ethics committees.

    Science.gov (United States)

    Sexson, Sandra B; Sexson, William R

    2008-01-01

    Over the past 30 years, institutional ethics committees have become the standard vehicle for addressing ethical issues in health care institutions. Early in this development, general psychiatrists became integrally involved; however, child and adolescent psychiatry roles on institutional ethics committees have been delineated less clearly. This article provides an overview of the functioning of institutional ethics committees, including composition and a definition of the roles across education, policy development, and case consultation. Within the context of the various roles of the institutional ethics committee, the potential contributions of a child and adolescent psychiatrist are defined and specific areas of expertise are delineated. Case examples are cited to demonstrate the unique contributions in the areas of developmental understanding, enhanced understanding of communication styles and failures, as well as an understanding of specific psychiatric factors and cultural issues that a child and adolescent psychiatrist may bring to the institutional ethics committee.

  7. Health care chaplains and their role on institutional ethics committees: an Australia study.

    Science.gov (United States)

    Carey, Lindsay B; Cohen, Jeffrey

    2010-06-01

    This paper presents the results of the largest Australian pastoral study concerning the perceptions of health care chaplains about their involvement on hospital research ethics committees (also known in some contexts as institutional ethics committees). Survey results from over 300 Australian health care chaplains indicated that nearly 90% of chaplains believed there was merit in chaplains serving on hospital research ethics committees, yet only a minority (22.7%) had ever participated on such committees. Data from in-depth interviews is also presented exploring the reasons for the lack of participation and the varying opinions regarding the role, appropriateness, and value of chaplains on ethics committees. Some implications of this study with respect to chaplaincy, hospital research ethics committees, health care institutions, ecclesiastical institutions, and government responsibilities are discussed.

  8. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

    OpenAIRE

    Bouësseau Marie-Charlotte; Coleman Carl H

    2008-01-01

    Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of ...

  9. Evaluation of Research Ethics Committees: Criteria for the Ethical Quality of the Review Process.

    Science.gov (United States)

    Scherzinger, Gregor; Bobbert, Monika

    2017-01-01

    Repeatedly, adequacy, performance and quality of Ethics Committees that oversee medical research trials are being discussed. Although they play a crucial role in reviewing medical research and protecting human subjects, it is far from clear to what degree they fulfill the task they have been assigned to. This eventuates in the call for an evaluation of their activity and, in some places, led to the establishment of accreditation schemes. At the same time, IRBs have become subject of detailed legislation in the process of the ongoing global juridification of medical research. Unsurprisingly, there is a tendency to understand the evaluation of RECs as a question of controlling their legal compliance. This paper discusses the need for a quality evaluation of IRBs from an ethical point of view and, by systematically reviewing the major ethical guidelines for IRBs, proposes a system of criteria that should orientate any evaluation of IRBs.

  10. Research ethics committee auditing: the experience of a university hospital.

    Science.gov (United States)

    Marchetti, Daniela; Spagnolo, Angelico; Cicerone, Marina; Cascini, Fidelia; La Monaca, Giuseppe; Spagnolo, Antonio G

    2013-09-01

    The authors report the first Italian experience of a research ethics committee (REC) audit focused on the evaluation of the REC's compliance with standard operating procedures, requirements in insurance coverage, informed consent, protection of privacy and confidentiality, predictable risks/harms, selection of subjects, withdrawal criteria and other issues, such as advertisement details and justification of placebo. The internal audit was conducted over a two-year period (March 2009-February 2011) divided into quarters to better value the influence of the new insurance coverage regulation that came into effect in March 2010 (Ministerial Decree of 14 July, 2009) and expand the requirements to safeguard participants in clinical drug trials including other critical items as information and consent and the risks to benefits ratio. Out of a total of 639 REC's opinions and research studies, 316 were reviewed. Regarding the insurance policy requirements, Auditor/REC non-compliance occurred only in one case. The highest number of Auditor/REC non-compliance was in regard to information and consent, which should have incurred a suspended decision rather than a favorable opinion. This internal audit shows the importance and the difficulty of the review process. For this reason, specific courses for members of the research ethics committee and for those who aspire to become auditors will be provided. There may also be efforts to improve the standard operating procedures already in place.

  11. Ethics and new reproductive technologies: an international review of committee statements.

    Science.gov (United States)

    Walters, LeRoy

    1987-06-01

    Walters examines the statements of advisory committees in eight countries on new practices involving human reproduction: clinical in vitro fertilization; surrogate motherhood; and human embryo research. He analyzes the positions taken by the committees on the general acceptability of the new technologies, as well as on specific issues involved in assisted human reproduction. In chronological order, the statements examined are those of the U.S. Ethics Advisory Board; the Waller committee in Victoria, Australia; a South Australian committee; the Demack committee in Queensland; Britain's Council for Science and Society; Britain's Warnock committee; a Tasmania, Australia, committee; the Ontario Law Reform Commission; Australia's Family Law Council; West Germany's Benda committee; the American Fertility Society; a Western Australia committee; the Dutch Health Council; and the National Ethics Committee of France.

  12. Nurses serving on clinical ethics committees: a qualitative exploration of a competency profile.

    Science.gov (United States)

    Cusveller, Bart

    2012-05-01

    The competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two to three fourth-year (bachelor) nursing students conducted 8 to 11 semi-structured interviews each with nurses in ethics committees. The question was what competencies these nurses themselves say they need to participate in such committees. This article reports the aggregate of the 52 interviews in these five studies. Regarding knowledge, the article reports on health law, ethics and professional knowledge. Regarding skills, communication is mentioned, as are professional skills and skills for 'doing ethics'. An open and respectful attitude towards patients and fellow committee members is required, as well as commitment to patient care, committee work and professional ethics. The right attitude for a nurse in an ethics committee is said to include a reflective and perceptive attitude, along with an awareness of one's own limitations and convictions. A detailed competency profile for nurses' participation in ethics committees as outlined in the recommendations may serve nursing education, institutional committees and nurses themselves to meet the demands of nurses' preparation for clinical ethics consultations.

  13. Research ethics committees and community values: Devlin, Dworkin, Hart and beyond.

    Science.gov (United States)

    Salako, Solomon E

    2010-03-01

    Two fundamental requirements ought to be met in any selection to research ethics committees: (i) professional scientific competence, and (ii) the understanding of moral values which prevail in any community. The question is: Should the verdicts of research ethics committees be based on community values? This article critically examines theories of community as were propounded by Devlin, Dworkin and Hart in answer to this question. It is argued that community values are complementary rather than conflicting, and that Dworkin's theory of community provides an analytical framework for research ethics on the new genetic technologies. Finally, it is submitted that the verdicts of research ethics committees should be based on community values.

  14. THE ROLE OF GOOD PRACTICES IN THE MANAGEMENT OF ETHICAL PROGRAMS IN HOSPITAL ESTABLISHMENTS. A FURTHER STEP FROM ETHICS COMMITTEES

    Directory of Open Access Journals (Sweden)

    AGHEORGHIESEI (CORODEANU DANIELA-TATIANA

    2012-09-01

    Full Text Available This article is a review of both the functions and roles played by ethics committees in hospital establishments,and respectively of the challenges they are confronted with, in the general context of activities concerned withorganizational ethics. Furthermore, we analyse international good practices, such as they intervene in the organizationof ethical programs, and also the place the committees take up within these programs. Our qualitative research isbased on the analysis of the websites of 144 hospitals from Romania, classified within the first three competence levels,and aims at highlighting the fact that ethics committees do not have sufficient visibility, which is certainly notbeneficial to patients. In this context, our research demonstrates that there is plenty space for improvement in quality ofcare based on ethics program and its tools and the experience of other countries could serve as a viable guide.

  15. Oversight of Genomic Data Sharing: What Roles for Ethics and Data Access Committees?

    Science.gov (United States)

    Shabani, Mahsa; Dove, Edward S; Murtagh, Madeleine; Knoppers, Bartha Maria; Borry, Pascal

    2017-10-01

    Discussions regarding responsible genomic data sharing often center around ethical and legal issues such as the consent, privacy, and confidentiality of individuals, families, and communities. To ensure the ethical grounds of genomic data sharing, oversight by both research ethics and Data Access Committees (DACs) across the research lifecycle is warranted. In this article, we review these oversight practices and argue that they reveal a compelling need to clarify the scope of ethical considerations by oversight bodies and to delineate core elements such as "objectionable" data uses. Ethical oversight of genomic data sharing would be considerably improved if the relevant ethical considerations by research ethics and DACs were coordinated. We therefore suggest several mechanisms to achieve greater clarification of ethical considerations by these committees, as well as greater communication and coordination between both to ensure robust and sustained ethical oversight of genomic data sharing.

  16. Requirements for ethics committee review for studies submitted to Implementation Science.

    Science.gov (United States)

    Eccles, Martin P; Weijer, Charles; Mittman, Brian

    2011-03-31

    The requirement for ethics review of studies submitted to Implementation Science has been unclear. Therefore, in this editorial, we set out our requirements for ethics committee review of experimental and non-experimental studies. For any study that meets the criteria of human subject research (which includes research on healthcare providers), irrespective of study design, we will require proof of either satisfactory ethics committee review or of the granting of an official exemption or waiver.

  17. Stating the Case for Nursing Research Ethics Committees: A Discussion Paper.

    Science.gov (United States)

    Mitchell, Theresa; Fletcher, Ian

    1998-01-01

    Nurse-led research ethics committees are generally more tolerant of diversity in research proposals than are medical committees steeped in empirical traditions. However, national trends in nursing in Britain may influence a preference for multidisciplinary over nurse-led committees. (SK)

  18. Qualitative analysis of healthcare professionals' viewpoints on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas.

    Science.gov (United States)

    Marcus, Brian S; Shank, Gary; Carlson, Jestin N; Venkat, Arvind

    2015-03-01

    Ethics consultation is a commonly applied mechanism to address clinical ethical dilemmas. However, there is little information on the viewpoints of health care providers towards the relevance of ethics committees and appropriate application of ethics consultation in clinical practice. We sought to use qualitative methodology to evaluate free-text responses to a case-based survey to identify thematically the views of health care professionals towards the role of ethics committees in resolving clinical ethical dilemmas. Using an iterative and reflexive model we identified themes that health care providers support a role for ethics committees and hospitals in resolving clinical ethical dilemmas, that the role should be one of mediation, rather than prescription, but that ultimately legal exposure was dispositive compared to ethical theory. The identified theme of legal fears suggests that the mediation role of ethics committees is viewed by health care professionals primarily as a practical means to avoid more worrisome medico-legal conflict.

  19. ETHICAL AND LEGAL ASPECTS OF FUNCTIONING OF ETHIC COMMITTEES IN BULGARIA

    Directory of Open Access Journals (Sweden)

    Mariela Deliverska

    2017-06-01

    Full Text Available Scientific research has to be based on ethical standards that promote the protection of human rights. On a national level, the domestic legislation of the Republic of Bulgaria foresees a procedure for obtaining an opinion from the Ethics Committee for Multicentre Trials in order to introduce a substantial change in a clinical trial and non-interventional study. The procedure aims to evaluate the compliance of the planned clinical trial with the norms of good clinical practice, the requirements of the Medicinal Products in Human Medicine Act. On European Union level, standards have been set down in Regulation (EC No. 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use. The licensing regime that has been introduced on a national level requires the performance of documentation evaluation that addresses a major change in a clinical trial and non-interventional research. Legal definitions of the terms "principal investigator" and "coordinating investigator" have been introduced. The "principal investigator" is the medical doctor or the dentist, designated by the sponsor, who leads the overall execution of the clinical trial in accordance with the approved protocol and good clinical practice guidelines and is responsible for the researchers. The "coordinating researcher" is a researcher appointed to coordinate researchers from different centres participating in a multicentre trial. Ethic committees performing review have to provide independent advice on the extent to which a biomedical research proposal complies with recognized ethical standards. Scientific research must necessarily conform to commonly accepted scientific principles and be based on thorough knowledge of scientific literature and other relevant sources of information.

  20. Roles and responsibilities of clinical ethics committees in priority setting.

    Science.gov (United States)

    Magelssen, Morten; Miljeteig, Ingrid; Pedersen, Reidar; Førde, Reidun

    2017-12-01

    Fair prioritization of healthcare resources has been on the agenda for decades, but resource allocation dilemmas in clinical practice remain challenging. Can clinical ethics committees (CECs) be of help? The aim of the study was to explore whether and how CECs handle priority setting dilemmas and contribute to raising awareness of fairness concerns. Descriptions of activities involving priority setting in annual reports from Norwegian CECs (2003-2015) were studied and categorized through qualitative content analysis. Three hundred thirty-nine reports from 38 CECs were studied. We found 78 activities where resource use or priority setting were explicitly highlighted as main topics. Of these, 29 were seminars or other educational activities, 21 were deliberations on individual patient cases, whereas 28 were discussions of principled or general cases. Individual patient cases concerned various distributional dilemmas where values were at stake. Six main topics and seven roles for the CEC were identified. CECs handle issues concerning the introduction of new costly drugs, extraordinarily costly established treatment, the application of priority setting criteria, resource use for vulnerable groups, resource constraints compromising practice, and futility of care. The CEC can act as an analyst, advisor, moderator, disseminator, facilitator, watch dog, and guardian of values and laws. In order to fulfil their responsibilities in handling priority setting cases, CECs need knowledge of both the ethics and the institutionalized systems of priority setting. There is potential for developing this aspect of the CECs' work further. The Norwegian CECs are involved in priority setting decisions where they can play multiple constructive roles. In particular, they advise and raise awareness of ethical aspects in resource allocations; bridge clinical practice with higher-level decisions; and promote fair resource allocation and stakeholder rights and interests.

  1. A "next generation" ethics committee. St. Joseph Health system has integrated performance-improvement features into its ethics work.

    Science.gov (United States)

    Murphy, Kevin

    2006-01-01

    Understanding the limitations that accompany the traditional model of ethics committees, St. Joseph Health System (SJHS), Orange, CA, has been working to integrate ethics expertise and quality-improvement methodology into its "Next Generation Model" (NG Model) for such committees. However, moving from a traditional structure to the NG Model (introduced to SJHS facilities in 1999) brought some challenges, not the least of which was a deep-rooted culture of resistance to change. Following a 2004 audit of how the NG model was working, some common challenges were identified. To deal with those challenges, SJHS developed some tools and techniques that have helped ease the ongoing transition. These tools have helped the system's ethics committees address such issues as collaboration for the sake of organizational integration, setting goals, and measuring performance of various ethics roles.

  2. A cross-sectional survey to investigate community understanding of medical research ethics committees.

    Science.gov (United States)

    Fritschi, Lin; Kelsall, Helen L; Loff, Bebe; Slegers, Claudia; Zion, Deborah; Glass, Deborah C

    2015-07-01

    Study explanatory forms often state that an ethics committee has approved a research project. To determine whether the lay community understand the roles of ethics committees in research, we took a cross-sectional national sample from three sampling frames: the general population (n=1532); cohort study participants (n=397); and case-control study participants (n=151). About half (51.3%) of the participants had heard of ethics committees. Those who had were more likely to be those who had participated in previous surveys, older participants, those born in Australia and those with higher education. Almost all participants agreed that the roles of an ethics committee were to protect participants' privacy and ensure no harm came to study participants and most agreed that the committee's role was to ensure that the research was capable of providing answers. Case-control and cohort participants were more likely than the general population to consider that the role of an ethics committee was to design the research and obtain research funding. Overall, we found that about half of the population are aware of ethics committees and that most could correctly identify that ethics committees are there to protect the welfare and rights of research participants, although a substantial minority had some incorrect beliefs about the committees' roles. Increased education, particularly for migrants and older people, might improve understanding of the role of ethics committees in research. 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.

  3. Ethical review from the inside: repertoires of evaluation in Research Ethics Committee meetings.

    Science.gov (United States)

    de Jong, Jean Philippe; van Zwieten, Myra C B; Willems, Dick L

    2012-09-01

    Evaluating the practice of ethical review by Research Ethics Committees (REC) could help protect the interests of human participants and promote scientific progress. To facilitate such evaluations, we conducted an ethnographic study of how an REC reviews research proposals during its meetings. We observed 13 meetings of a Dutch REC and studied REC documents. We coded this material inductively and categorised these codes in two repertoires of evaluation: a repertoire of rules and a repertoire of production. In the repertoire of rules the REC applies rules, weighs scientific value and burdens to the participants and makes a final judgment on a research proposal in a meeting. In the repertoire of production, REC members check documents and forms and advise researchers on how to improve their proposals and can use informal communication. Based on these findings, we think that evaluations of the practice of ethical review should take into account the fact that RECs can use a repertoire of rules and a repertoire of production to evaluate research proposals. Combining these two repertoires can be a viable option so that the REC gives researchers advice on how to improve their proposals to prevent rejection of valuable research. © 2012 The Authors. Sociology of Health & Illness © 2012 Foundation for the Sociology of Health & Illness/Blackwell Publishing Ltd.

  4. Ethics committees and the changed clinical research environment in India in 2016: A perspective!

    Directory of Open Access Journals (Sweden)

    Sanish Davis

    2017-01-01

    Conclusion: Recent changes in regulations have on the one hand empowered Ethics committees but brought in challenges in the way that they provide oversight and monitor research carried out at the site.

  5. The role of a pediatric ethics committee in the newborn intensive care unit.

    Science.gov (United States)

    Mercurio, M R

    2011-01-01

    Institutional Ethics Committees are commonly available in hospitals with newborn intensive care units, and may serve as a valuable resource for staff and parents dealing with difficult ethical decisions. Many clinicians may be unaware of when the committee might be helpful, or how it functions. After a brief historical introduction, two cases are presented as illustrations of pediatric ethics committee function. The first involves consideration of cardiac surgery for an infant with ventricular septal defect and Trisomy 13. The second involves disagreement between staff and parents regarding possible provision of cardio-pulmonary resuscitation in a terminally ill newborn. Principles and considerations often brought to bear in committee deliberations are reviewed for each case. Neonatologists, staff and families should be aware of this potentially valuable resource, and are encouraged to use it for situations of moral distress, conflict resolution or ethical uncertainty.

  6. Protecting vulnerable research participants: a Foucault-inspired analysis of ethics committees.

    Science.gov (United States)

    Juritzen, Truls I; Grimen, Harald; Heggen, Kristin

    2011-09-01

    History has demonstrated the necessity of protecting research participants. Research ethics are based on a concept of asymmetry of power, viewing the researcher as powerful and potentially dangerous and establishing ethics committees as external agencies in the field of research. We argue in favour of expanding this perspective on relationships of power to encompass the ethics committees as one among several actors that exert power and that act in a relational interplay with researchers and participants. We employ Michel Foucault's ideas of power as an omnipresent force which is dynamic and unstable, as well as the notion that knowledge and power are inextricably intertwined. The article discusses how research ethics committees may affect academic freedom. In addition it is pointed out that research participants could be harmed - not only by unfortunate research practices, but also by being subjected to the protective efforts of ethics monitoring bodies.

  7. Familiar ethical issues amplified: how members of research ethics committees describe ethical distinctions between disaster and non-disaster research.

    Science.gov (United States)

    Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa; Hunt, Matthew

    2017-06-28

    The conduct of research in settings affected by disasters such as hurricanes, floods and earthquakes is challenging, particularly when infrastructures and resources were already limited pre-disaster. However, since post-disaster research is essential to the improvement of the humanitarian response, it is important that adequate research ethics oversight be available. We aim to answer the following questions: 1) what do research ethics committee (REC) members who have reviewed research protocols to be conducted following disasters in low- and middle-income countries (LMICs) perceive as the key ethical concerns associated with disaster research?, and 2) in what ways do REC members understand these concerns to be distinct from those arising in research conducted in non-crisis situations? This qualitative study was developed using interpretative description methodology; 15 interviews were conducted with REC members. Four key ethical issues were identified as presenting distinctive considerations for disaster research to be implemented in LMICs, and were described by participants as familiar research ethics issues that were amplified in these contexts. First, REC members viewed disaster research as having strong social value due to its potential for improving disaster response, but also as requiring a higher level of justification compared to other research settings. Second, they identified vulnerability as an overarching concern for disaster research ethics, and a feature that required careful and critical appraisal when assessing protocols. They noted that research participants' vulnerabilities frequently change in the aftermath of a disaster and often in unpredictable ways. Third, they identified concerns related to promoting and maintaining safety, confidentiality and data security in insecure or austere environments. Lastly, though REC members endorsed the need and usefulness of community engagement, they noted that there are significant challenges in a disaster

  8. Training needs assessment in research ethics evaluation among research ethics committee members in three African countries: Cameroon, Mali and Tanzania.

    Science.gov (United States)

    Ateudjieu, Jérôme; Williams, John; Hirtle, Marie; Baume, Cédric; Ikingura, Joyce; Niaré, Alassane; Sprumont, Dominique

    2010-08-01

    As actors with the key responsibility for the protection of human research participants, Research Ethics Committees (RECs) need to be competent and well-resourced in order to fulfil their roles. Despite recent programs designed to strengthen RECs in Africa, much more needs to be accomplished before these committees can function optimally. To assess training needs for biomedical research ethics evaluation among targeted countries. Members of RECs operating in three targeted African countries were surveyed between August and November 2007. Before implementing the survey, ethical approvals were obtained from RECs in Switzerland, Cameroon, Mali and Tanzania. Data were collected using a semi-structured questionnaire in English and in French. A total of 74 respondents participated in the study. The participation rate was 68%. Seventy one percent of respondents reported having received some training in research ethics evaluation. This training was given by national institutions (31%) and international institutions (69%). Researchers and REC members were ranked as the top target audiences to be trained. Of 32 topics, the top five training priorities were: basic ethical principles, coverage of applicable laws and regulations, how to conduct ethics review, evaluating informed consent processes and the role of the REC. Although the majority of REC members in the targeted African countries had received training in ethics, they expressed a need for additional training. The results of this survey have been used to design a training program in research ethics evaluation that meets this need.

  9. In the lion's den? Experiences of interaction with research ethics committees

    OpenAIRE

    Fistein, Elizabeth; Quilligan, Sally

    2011-01-01

    Research ethics review is an important process, designed to protect participants in medical research. However, it is increasingly criticised for failing to meet its aims. Here, two researchers reflect on their experiences of applying for ethical approval of observational research in clinical settings. They highlight some problems faced by reviewers and researchers and propose a two-stage ethical review process that would alert researchers to the committee's concerns and allow them to give a m...

  10. Evaluation in health promotion: thoughts from inside a human research ethics committee.

    Science.gov (United States)

    Allen, Judy; Flack, Felicity

    2015-12-01

    Health promotion research, quality improvement and evaluation are all activities that raise ethical issues. In this paper, the Chair and a member of human resear ch ethics committees provide an insiders' point of view on how to demonstrate ethical conduct in health promotion research and quality improvement. Several common issues raised by health promotion research and evaluation are discussed including researcher integrity, conflicts of interest, use of information, consent and privacy.

  11. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review.

    Science.gov (United States)

    Coleman, Carl H; Bouësseau, Marie-Charlotte

    2008-03-28

    Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of studies? Second, does the process affect prospective

  12. How do we know that research ethics committees are really working? The neglected role of outcomes assessment in research ethics review

    Directory of Open Access Journals (Sweden)

    Bouësseau Marie-Charlotte

    2008-03-01

    Full Text Available Abstract Background Countries are increasingly devoting significant resources to creating or strengthening research ethics committees, but there has been insufficient attention to assessing whether these committees are actually improving the protection of human research participants. Discussion Research ethics committees face numerous obstacles to achieving their goal of improving research participant protection. These include the inherently amorphous nature of ethics review, the tendency of regulatory systems to encourage a focus on form over substance, financial and resource constraints, and conflicts of interest. Auditing and accreditation programs can improve the quality of ethics review by encouraging the development of standardized policies and procedures, promoting a common base of knowledge, and enhancing the status of research ethics committees within their own institutions. However, these mechanisms focus largely on questions of structure and process and are therefore incapable of answering many critical questions about ethics committees' actual impact on research practices. The first step in determining whether research ethics committees are achieving their intended function is to identify what prospective research participants and their communities hope to get out of the ethics review process. Answers to this question can help guide the development of effective outcomes assessment measures. It is also important to determine whether research ethics committees' guidance to investigators is actually being followed. Finally, the information developed through outcomes assessment must be disseminated to key decision-makers and incorporated into practice. This article offers concrete suggestions for achieving these goals. Conclusion Outcomes assessment of research ethics committees should address the following questions: First, does research ethics committee review improve participants' understanding of the risks and potential benefits of

  13. PROFESSIONAL CODES OF CONDUCT IN PSYCHOLOGY: DESCRIPTIVE STUDY OF COMPLAINTS REVIEWED BY THE COPC ETHICS COMMITTEE

    Directory of Open Access Journals (Sweden)

    Mila Arch

    2013-09-01

    Full Text Available In recent decades a significant increase has been observed in the number of complaints filed with ethical committees. The possibility of being the subject of a complaint is therefore a growing concern for professionals. However, research on ethics and codes of conduct in psychology is still very limited and real data on the complaints filed with Ethics Committees against psychologists are practically nonexistent. This article describes the results of a descriptive analysis of the complaints reviewed by the COPC Ethics Committee from 1998 to 2011. A total of 324 complaints were filed, but only 20% led to opening disciplinary proceedings, the judicial context being the professional area in which the highest percentage of complaints were filed (85%. Among the most prevalent reasons for complaints were making assessments without prior examination and partiality.

  14. Can UK NHS research ethics committees effectively monitor publication and outcome reporting bias?

    Science.gov (United States)

    Begum, Rasheda; Kolstoe, Simon

    2015-07-25

    Publication and outcome reporting bias is often caused by researchers selectively choosing which scientific results and outcomes to publish. This behaviour is ethically significant as it distorts the literature used for future scientific or clinical decision-making. This study investigates the practicalities of using ethics applications submitted to a UK National Health Service (NHS) research ethics committee to monitor both types of reporting bias. As part of an internal audit we accessed research ethics database records for studies submitting an end of study declaration to the Hampshire A research ethics committee (formerly Southampton A) between 1st January 2010 and 31st December 2011. A literature search was used to establish the publication status of studies. Primary and secondary outcomes stated in application forms were compared with outcomes reported in publications. Out of 116 studies the literature search identified 57 publications for 37 studies giving a publication rate of 32%. Original Research Ethics Committee (REC) applications could be obtained for 28 of the published studies. Outcome inconsistencies were found in 16 (57%) of the published studies. This study showed that the problem of publication and outcome reporting bias is still significant in the UK. The method described here demonstrates that UK NHS research ethics committees are in a good position to detect such bias due to their unique access to original research protocols. Data gathered in this way could be used by the Health Research Authority to encourage higher levels of transparency in UK research.

  15. 77 FR 34046 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2012-06-08

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... ACD, CDC, regarding a broad range of public health ethics questions and issues arising from programs... ethics standards to the accreditation process for public health departments; ethical considerations...

  16. International variation in ethics committee requirements: comparisons across five Westernised nations

    Directory of Open Access Journals (Sweden)

    Nachson Israel

    2002-04-01

    Full Text Available Abstract Background Ethics committees typically apply the common principles of autonomy, nonmaleficence, beneficence and justice to research proposals but with variable weighting and interpretation. This paper reports a comparison of ethical requirements in an international cross-cultural study and discusses their implications. Discussion The study was run concurrently in New Zealand, UK, Israel, Canada and USA and involved testing hypotheses about believability of testimonies regarding alleged child sexual abuse. Ethics committee requirements to conduct this study ranged from nil in Israel to considerable amendments designed to minimise participant harm in New Zealand. Assessment of minimal risk is a complex and unreliable estimation further compounded by insufficient information on probabilities of particular individuals suffering harm. Estimating potential benefits/ risks ratio and protecting participants' autonomy similarly are not straightforward exercises. Summary Safeguarding moral/humane principles should be balanced with promotion of ethical research which does not impede research posing minimal risk to participants. In ensuring that ethical standards are met and research has scientific merit, ethics committees have obligations to participants (to meet their rights and protect them from harm; to society (to ensure good quality research is conducted; and to researchers (to treat their proposals with just consideration and respect. To facilitate meeting all these obligations, the preferable focus should be promotion of ethical research, rather than the prevention of unethical research, which inevitably results in the impediment of researchers from doing their work. How the ethical principles should be applied and balanced requires further consideration.

  17. Capacity mapping of national ethics committees in the Eastern Mediterranean Region.

    Science.gov (United States)

    Abou-Zeid, Alaa; Afzal, Mohammad; Silverman, Henry J

    2009-07-04

    Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

  18. Capacity mapping of national ethics committees in the Eastern Mediterranean Region

    Directory of Open Access Journals (Sweden)

    Afzal Mohammad

    2009-07-01

    Full Text Available Abstract Background Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs in the Eastern Mediterranean (EM region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. Methods We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. Results We obtained responses from 77% (17/22 of the EM countries; 88% (15/17 of the countries stated they had NECs. Of these NECs, 40% (6/15 were involved in the ethics of science and technology, 73% (11/15 in medical ethics, and 93% (14/15 in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15 met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15 of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15 received financial support and 60% (9/15 had administrative support. Conclusion While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

  19. [Difficulties and possibilities of ethics committees in a Latin-American perspective].

    Science.gov (United States)

    Franca-Tarragó, Omar

    2007-01-01

    Although ethics committees in Latin America have become an essential element in the development and appropriation of bioethics on the continent, the experience of the reality of the working of the diverse existing committees nevertheless shows a certain structural weakness due in particular to the lack of involvement of the health and research institutions, the doctors themselves and the lack of training and methodology in the committees' work. Consequently it is especially necessary to develop strategies to allow the committees and their members to fulfil the missions for which they have been set up.

  20. Reporting ethics committee approval in public administration research.

    Science.gov (United States)

    Jordan, Sara R; Gray, Phillip W

    2014-03-01

    While public administration research is thriving because of increased attention to social scientific rigor, lingering problems of methods and ethics remain. This article investigates the reporting of ethics approval within public administration publications. Beginning with an overview of ethics requirements regarding research with human participants, I turn to an examination of human participants protections for public administration research. Next, I present the findings of my analysis of articles published in the top five public administration journals over the period from 2000 to 2012, noting the incidences of ethics approval reporting as well as funding reporting. In explicating the importance of ethics reporting for public administration research, as it relates to replication, reputation, and vulnerable populations, I conclude with recommendations for increasing ethics approval reporting in public administration research.

  1. [What a surgeon needs to know of the work of a medical ethics committee/institutional review board].

    Science.gov (United States)

    Beck, N

    2015-02-01

    Ethical committees or institutional review boards are interdisciplinary committees to assess the ethical, social, legal and medical aspects of research involving human subjects. The ethics commission is to protect both the patient as well as the investigators and other personnel involved in the implementation of scientific projects. According to the professional code (Berufsordnung) every physician is obliged to consult an ethics committee to get a an approval before carrying out a research project. Concerning the Declaration of Helsinki, the advice of physicians is an international standard before carrying out a research project. In addition to the advisory function the ethics committee has an authorisation function within the pharmaceutical and medical device law. In the present publication the advisory and authorisation functions of an German ethics committee are briefly explained. Georg Thieme Verlag KG Stuttgart · New York.

  2. 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

  3. Knowledge about the research and ethics committee at Makerere ...

    African Journals Online (AJOL)

    Most of the respondents do agree that the REC functions include Protocol review 86%, protection of research participants 84.3%, and monitoring of ongoing research. During ethical review, the RECpays special attention to scientific design [79.7%] and ethical issues [75.3%], but less to the budget and literature review.

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

    Science.gov (United States)

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

    2015-09-14

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

  5. Assessing physicians' roles on health care ethics committees.

    Science.gov (United States)

    McDaniel, Charlotte

    2010-12-01

    The purpose of this study was to examine the role of physicians on HEC including structural and process features. Four committees were selected from among 12 volunteering to participate with 12 sessions observed. Power analysis (0.8) confirmed an adequate number of communication exchanges, and no statistical significant difference (p role effectiveness lower than other occupations and lower than overall committee effectiveness. Communication exchanges representing process revealed three positive communication types, and consistent attempts to aid committee functions through consensual processes that also were substantiated by non-physician members. Findings suggested more attention to both structural and process functions of HEC and their members.

  6. 75 FR 72831 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2010-11-26

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... strategy for addressing its charge to provide a preliminary overview to the ACD on ethical issues related...

  7. 77 FR 58397 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

    Science.gov (United States)

    2012-09-20

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and practitioners. Matters To Be Discussed: Agenda items will include the following topics: Ethical considerations...

  8. 76 FR 3909 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-01-21

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES..., regarding a broad range of public health ethics questions and issues arising from programs, scientists and... submitted on the ethical considerations document for the allocation of ventilators during a severe pandemic...

  9. 77 FR 2549 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2012-01-18

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and... territorial health departments in their efforts to address public health ethics challenges, approaches for...

  10. 76 FR 29755 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-05-23

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... of public health ethics questions and issues arising from programs, scientists and practitioners... April 28, 2011, ACD, CDC meeting; discussion of next steps on addressing potential public health ethical...

  11. 75 FR 30409 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention-Ethics...

    Science.gov (United States)

    2010-06-01

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention--Ethics Subcommittee (ES) In... to the ACD, CDC, regarding a broad range of public health ethics questions and issues arising from... address public health ethics issues and coordination of these efforts with the CDC Office of State, Tribal...

  12. 75 FR 57044 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2010-09-17

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... will provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and...; efforts to support state, tribal, local and territorial health departments address ethical issues in the...

  13. 76 FR 55678 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-09-08

    ... Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES... provide counsel to the ACD, CDC, regarding a broad range of public health ethics questions and issues... in their efforts to address public health ethics challenges. The agenda is subject to change as...

  14. Evaluation of the work of hospital districts' research ethics committees in Finland.

    Science.gov (United States)

    Halila, Ritva

    2014-12-01

    The main task of research ethics committees (RECs) is to assess research studies before their start. In this study, 24 RECs that evaluate medical research were sent questionnaires about their structure and functions. The RECs were divided into two separate groups: those working in university hospital districts (uRECs) and those in central hospital districts (non-uRECs). The two groups were different in many respects: the uRECs were bigger in size, covered a wider range of disciplines (both medical and non-medical), had better resources and more frequent and regular meetings. After the survey was performed and analysed, the Medical Research Act was amended so that only hospital districts with a medical faculty in their region had a duty to establish ethics committees. After the amendment, the number of RECs evaluating medical research in Finland decreased from 25 to 9. The ethics committees that remained had wider expertise and were better equipped already by the time of this survey. Only one non-uREC was continuing its work, and this was being done under the governance of a university hospital district. Simple measures were used for qualitative analysis of the work of RECs that evaluate medical research. These showed differences between RECs. This may be helpful in establishing an ethics committee network in a research field or administrational area. 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.

  15. Nurses serving on clinical ethics committees: A qualitative exploration of a competency profile

    NARCIS (Netherlands)

    dr. Bart Cusveller

    2014-01-01

    The competency profile underlying higher nursing education in the Netherlands states that bachelor-prepared nurses are expected to be able to participate in ethics committees. What knowledge, skills and attitudes are involved in this participation is unclear. In five consecutive years, groups of two

  16. Collaborative international research: ethical and regulatory issues pertaining to human biological materials at a South African institutional research ethics committee.

    Science.gov (United States)

    Sathar, Aslam; Dhai, Amaboo; van der Linde, Stephan

    2014-12-01

    Human Biological Materials (HBMs) are an invaluable resource in biomedical research. To determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Ethically approved retrospective cross-sectional descriptive audit. Of the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the REC of their intent to store HBMs. Only 132 protocols informed research participants (P research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively. Researchers and the REC did not adequately address the inter-related ethical and regulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. © 2013 John Wiley & Sons Ltd.

  17. The Ethics of Traditional Chinese and Western Herbal Medicine Research: Views of Researchers and Human Ethics Committees in Australia

    Directory of Open Access Journals (Sweden)

    Caroline A. Smith

    2011-01-01

    Full Text Available Despite the growth of traditional Chinese medicine (TCM and western herbal medicine (WHM research in Australia, little is known about how ethics committees (HRECs assess the ethics of TCM or WHM research. The objectives of this study were to examine the experiences of TCM and WHM researchers and HRECs with the evaluation of ethics applications. Two cross-sectional surveys were undertaken of HRECs and TCM and WHM researchers in Australia. Anonymous self-completion questionnaires were administered to 224 HRECs and 117 researchers. A response confirming involvement in TCM or WHM research applications was received from 20 HRECs and 42 researchers. The most frequent ethical issues identified by HRECs related to herbal products including information gaps relating to mode of action of herbal medicines and safety when combining herbal ingredients. Researchers concurred that they were frequently requested to provide additional information on multiple aspects including safety relating to the side effects of herbs and herb-drug interactions. Overall adherence with the principles of ethical conduct was high among TCM and WHM researchers although our study did identify the need for additional information regarding assessment of risk and risk management.

  18. The "Ethics Committee": A Practical Approach to Introducing Bioethics and Ethical Thinking

    Science.gov (United States)

    Goodwin, Mark; Kramer, Cas; Cashmore, Annette

    2012-01-01

    Bioethics is an increasingly important part of the biosciences curriculum at school and in higher education, but few science teachers have much experience of teaching the subject in an engaging or interactive manner. This article sets out a session that allows students to practise the skills of ethical thinking and ethical debate in a relevant…

  19. Payment of research participants: current practice and policies of Irish research ethics committees.

    Science.gov (United States)

    Roche, Eric; King, Romaine; Mohan, Helen M; Gavin, Blanaid; McNicholas, Fiona

    2013-09-01

    Payment of research participants helps to increase recruitment for research studies, but can pose ethical dilemmas. Research ethics committees (RECs) have a centrally important role in guiding this practice, but standardisation of the ethical approval process in Ireland is lacking. Our aim was to examine REC policies, experiences and concerns with respect to the payment of participants in research projects in Ireland. Postal survey of all RECs in Ireland. Response rate was 62.5% (n=50). 80% of RECs reported not to have any established policy on the payment of research subjects while 20% had refused ethics approval to studies because the investigators proposed to pay research participants. The most commonly cited concerns were the potential for inducement and undermining of voluntary consent. There is considerable variability among RECs on the payment of research participants and a lack of clear consensus guidelines on the subject. The development of standardised guidelines on the payment of research subjects may enhance recruitment of research participants.

  20. Polish visit

    CERN Document Server

    2003-01-01

    On 6 October, Professor Michal Kleiber, Polish Minister of Science and Chairman of the State Committee for Scientific Research, visited CERN and met both the current and designated Director General, Luciano Maiani and Robert Aymar. Professor Kleiber visited the CMS and ATLAS detector assembly halls, the underground cavern for ATLAS, and the LHC superconducting magnet string test hall. Michal Kleiber (left), Polish minister of science and Jan Krolikowski, scientist at Warsaw University and working for CMS, who shows the prototypes of the Muon Trigger board of CMS.

  1. Co-design and implementation research: challenges and solutions for ethics committees.

    Science.gov (United States)

    Goodyear-Smith, Felicity; Jackson, Claire; Greenhalgh, Trisha

    2015-11-16

    Implementation science research, especially when using participatory and co-design approaches, raises unique challenges for research ethics committees. Such challenges may be poorly addressed by approval and governance mechanisms that were developed for more traditional research approaches such as randomised controlled trials. Implementation science commonly involves the partnership of researchers and stakeholders, attempting to understand and encourage uptake of completed or piloted research. A co-creation approach involves collaboration between researchers and end users from the onset, in question framing, research design and delivery, and influencing strategy, with implementation and broader dissemination strategies part of its design from gestation. A defining feature of co-creation is its emergent and adaptive nature, making detailed pre-specification of interventions and outcome measures impossible. This methodology sits oddly with ethics committee protocols that require precise pre-definition of interventions, mode of delivery, outcome measurements, and the role of study participants. But the strict (and, some would say, inflexible) requirements of ethics committees were developed for a purpose - to protect participants from harm and help ensure the rigour and transparency of studies. We propose some guiding principles to help square this circle. First, ethics committees should acknowledge and celebrate the diversity of research approaches, both formally (through training) and informally (by promoting debate and discussion); without active support, their members may not understand or value participatory designs. Second, ground rules should be established for co-design applications (e.g. how to judge when 'consultation' or 'engagement' becomes research) and communicated to committee members and stakeholders. Third, the benefits of power-sharing should be recognised and credit given to measures likely to support this important goal, especially in research with

  2. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees – results from a descriptive questionnaire-based study

    OpenAIRE

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-01

    Background Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of...

  3. Are the votes of ethics committees in Germany for the protection of clinical study trial subjects "sovereign acts?".

    Science.gov (United States)

    Graf, Hans-Peter

    2013-06-01

    A sudden paradigm shift has resulted in governmental measures that greatly impact the scope in which the ethics committees in Germany can perform their task of providing expert opinions for clinical research. The so-called "revaluation" of the Medical Device Law Deutsches Medizinproduktegesetz-MPG) is, in our opinion, not based on sound political and professional judgment. In accordance with the changed regulations, ethics committees are now seen as being sub-organs of the state medical associations or the medical faculties and are therefore official authorities. It follows that the votes of ethics committees are then "sovereign acts" or authoritative measures! However, equality and justice speak against this misleading conclusion and its resulting consequence that an ethics committee's vote is a sovereign act. This has, in turn, resulted in the public ethics committees obtaining their long-sought goal of having a state-sanctioned monopoly. The private ethics committees are not recognized as being authoritative bodies, nor are they to be seen as such in the future (i.e. such a status has been denied the Freiburg Ethics Commission International (FEKI) in Baden-Württemberg). This political mistake must be corrected, otherwise, conducting clinical research will become increasingly difficult.

  4. Global summit of national ethics committees: an essential tool for international dialogue and consensus-building.

    Science.gov (United States)

    Bouësseau, Marie-Charlotte; Reis, Andreas; Ho, W Calvin

    2011-01-01

    July 2010, important decisions were taken to ensure the continuity Held for the first time in 1996, the Global Summit of National of activities between the Summits. This article intends to briefly Ethics Committees (NECs) is a key platform for dialogue and retrace the history and analyse the role and functioning of the fostering consensus on ethical issues at a global level. At the Global Summit. It also discusses future challenges for international Eighth Global Summit meeting, which took place in Singapore in collaboration of NECs.

  5. Financial "risk-sharing" or refund programs in assisted reproduction: an Ethics Committee opinion.

    Science.gov (United States)

    2016-10-01

    Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee but provide reduced fees for subsequent cycles and often a partial or complete refund if treatment fails. This opinion of the ASRM Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient informed consent. This document replaces the document of the same name, last published in 2013 (Fertil Steril 2013;100:334-6). Copyright © 2016 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  6. 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.

  7. The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

    Science.gov (United States)

    Hunt, Matthew; Tansey, Catherine M; Anderson, James; Boulanger, Renaud F; Eckenwiler, Lisa; Pringle, John; Schwartz, Lisa

    2016-01-01

    Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs), in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries. We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques. Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process. Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be taken to ensure that

  8. The Challenge of Timely, Responsive and Rigorous Ethics Review of Disaster Research: Views of Research Ethics Committee Members.

    Directory of Open Access Journals (Sweden)

    Matthew Hunt

    Full Text Available Research conducted following natural disasters such as earthquakes, floods or hurricanes is crucial for improving relief interventions. Such research, however, poses ethical, methodological and logistical challenges for researchers. Oversight of disaster research also poses challenges for research ethics committees (RECs, in part due to the rapid turnaround needed to initiate research after a disaster. Currently, there is limited knowledge available about how RECs respond to and appraise disaster research. To address this knowledge gap, we investigated the experiences of REC members who had reviewed disaster research conducted in low- or middle-income countries.We used interpretive description methodology and conducted in-depth interviews with 15 respondents. Respondents were chairs, members, advisors, or coordinators from 13 RECs, including RECs affiliated with universities, governments, international organizations, a for-profit REC, and an ad hoc committee established during a disaster. Interviews were analyzed inductively using constant comparative techniques.Through this process, three elements were identified as characterizing effective and high-quality review: timeliness, responsiveness and rigorousness. To ensure timeliness, many RECs rely on adaptations of review procedures for urgent protocols. Respondents emphasized that responsive review requires awareness of and sensitivity to the particularities of disaster settings and disaster research. Rigorous review was linked with providing careful assessment of ethical considerations related to the research, as well as ensuring independence of the review process.Both the frequency of disasters and the conduct of disaster research are on the rise. Ensuring effective and high quality review of disaster research is crucial, yet challenges, including time pressures for urgent protocols, exist for achieving this goal. Adapting standard REC procedures may be necessary. However, steps should be

  9. [Reorganization of the procedures and the tasks of the responsible ethics committees after the 12th AMG amendment. Concepts of the permanent working group of the medical ethics committees in Germany].

    Science.gov (United States)

    Wessler, I; Burger, R; Doppelfeld, E

    2005-02-01

    Since 12(th) of August 2004 the EU Directive 2001/20/EG has been implemented into the national law. The 12th AMG amendment of 30 July 2004 and the good clinical practice decree on the conduct of clinical trials on drugs for human use of 9 August 2004 have been authorized and must be considered for new clinical trials with investigational medical products (drugs). The scope of the changes are to increase the quality of clinical trials and to continue the process of harmonization within the European Community. Based on the new law the sponsor has to apply for approval by the competent authority and for a favourable opinion by the responsible ethics committee. Both procedures are independent; a favourable opinion of the responsible ethics committee is a necessary condition before starting the trial. Thus, the role of the ethics committees has been changed; the committees are considered as an institution comparable to an authority to protect the rights and safety of human subjects involved in clinical trials. The permanent working group of the medical ethics committees in Germany has established a procedure to meet these requirements, particularly in the case of multicentre clinical trials, where only a single opinion shall be given for each member state. This article describes this procedure (application, process of ethical consideration among the leading and local ethics committees in multicentre trials, responsibilities during the trial).

  10. Assessing Institutional Ethics Committees in India Using the IRB-RAT.

    Science.gov (United States)

    Chenneville, Tiffany; Menezes, Lynette; Bylsma, Lauren M; Mann, Angela; Kosambiya, Jayendrakumar; Baxi, Rajendra

    2014-10-01

    Institutional ethics committees (IECs) are currently still in their infancy in low- to middle-income countries (LMICs), which may have important implications with regard to the oversight of the protection of human participants. Understanding how these IECs currently function is a critical first step in helping LMICs build infrastructures that support the protection of research participants and improve the scientific quality of health research worldwide. We assessed the functioning of the IECs at two medical colleges in Gujarat, India, by administering the Institutional Review Board Researcher's Assessment Tool (IRB-RAT) to 42 IEC and faculty members. The IRB-RAT includes eight scales assessing various domains related to how investigators and members perceive their ethics committees. Results from t tests revealed significant differences between ideal ratings and descriptive ratings on each of the IRB-RAT scales with ideal ratings being higher than current descriptive ratings on all of the scales (values of Indian IECs. © The Author(s) 2014.

  11. Italian ethical committee intervention in a case of embryo-fetal medicine.

    Science.gov (United States)

    Cannovo, Nunzia; Buccelli, Paola; Bryce, Jane

    2011-06-01

    Embryo-fetal experimentation is intuitively associated with a therapeutic intent, according to a consolidated line of thought on the international and national levels. We report on a researcher's request for Ethics Committee approval to perform intrauterine transplantation of stem cells via cordocentesis on a fetus diagnosed with dystrophic epidermolysis bullosa, using stem cells obtained from a sibling's umbilical cord blood. The Ethics Committee rejected the request because of deontological issues and clinical judgments about the potential good to be derived from the procedure. In particular, in this case there was no preclinical or animal research on the procedure, the risk factors for mother and fetus were unknown, there was no way to guarantee compliance with Italian laws regarding safety and quality of the donor cells, and there was lack of clear informed consent.

  12. What is the role of ethics committees after Regulation (EU) 536/2014?

    Science.gov (United States)

    Petrini, Carlo

    2016-03-01

    EU Regulation 536/2014 stipulates that when assessing applications for authorisation to conduct clinical trials, Member States should formulate a 'single decision'. This raises the problem of identifying: (1) the facility designated to express this 'single decision' and (2) the role of ethics committees in the decision-making process. The article addresses the consequences of the requirement that for each Member State the assessment of an application for approval to conduct a trial must take the form of a 'single decision' by the Member State concerned. Three possible approaches to the procedures for expressing that 'single decision' and to the role of ethics committees in the decision-making process are described, one of which is indicated as the preferred option. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  13. Evaluation of Viewpoints of Health Care Professionals on the Role of Ethics Committees and Hospitals in the Resolution of Clinical Ethical Dilemmas Based on Practice Environment.

    Science.gov (United States)

    Marcus, Brian S; Carlson, Jestin N; Hegde, Gajanan G; Shang, Jennifer; Venkat, Arvind

    2016-03-01

    We sought to evaluate whether health care professionals' viewpoints differed on the role of ethics committees and hospitals in the resolution of clinical ethical dilemmas based on practice location. We conducted a survey study from December 21, 2013 to March 15, 2014 of health care professionals at six hospitals (one tertiary care academic medical center, three large community hospitals and two small community hospitals). The survey consisted of eight clinical ethics cases followed by statements on whether there was a role for the ethics committee or hospital in their resolution, what that role might be and case specific queries. Respondents used a 5-point Likert scale to express their degree of agreement with the premises posed. We used the ANOVA test to evaluate whether respondent views significantly varied based on practice location. 240 health care professionals (108-tertiary care center, 92-large community hospitals, 40-small community hospitals) completed the survey (response rate: 63.6 %). Only three individual queries of 32 showed any significant response variations across practice locations. Overall, viewpoints did not vary across practice locations within question categories on whether the ethics committee or hospital had a role in case resolution, what that role might be and case specific queries. In this multicenter survey study, the viewpoints of health care professionals on the role of ethics committees or hospitals in the resolution of clinical ethics cases varied little based on practice location.

  14. Research Ethics Committees and Participatory Action Research With Young People: The Politics of Voice.

    Science.gov (United States)

    Yanar, Zeynep M; Fazli, Mehria; Rahman, Jahanara; Farthing, Rys

    2016-04-01

    Participatory action research (PAR) is a methodological approach that seeks to maximize the participation of people whose lives it researches. It is underpinned by an ethical concern to research "with" people, rather than "on" people. However, this ethical approach to research is often, paradoxically, problematized by universities' research ethics committees (RECs). This article explores one site of tension between PAR and RECs-the requirement for anonymity for below 18-year-olds. It explores this tension by exploring a case study of a peer-to-peer research project undertaken by young women in East London, and using our own experiences and perspectives, it argues that anonymity can be unjust, disempowering, and unnecessary, and can reduce "pride." Without wanting to develop specific recommendations, given the limited scope of our case study, this article uses firsthand experiences to add weight to the broader discussions calling for a critical rethink of REC guidelines. © The Author(s) 2016.

  15. Committee Opinion No. 695: Sterilization of Women: Ethical Issues and Considerations.

    Science.gov (United States)

    2017-04-01

    Sterilization is the most common method of contraception among married couples, with nearly twice as many couples choosing female partner sterilization over male sterilization. Although sterilization is among the most straightforward surgical procedures an obstetrician-gynecologist performs, it is enormously complex when considered from a historical, sociological, or ethical perspective. Sterilization practices have embodied a problematic tension, in which some women who desired fertility were sterilized without their knowledge or consent, and other women who wanted sterilization to limit their family size lacked access to it. An ethical approach to the provision of sterilization must, therefore, promote access for women who wish to use sterilization as a method of contraception, but at the same time safeguard against coercive or otherwise unjust uses. This Committee Opinion reviews ethical issues related to the sterilization of women and outlines an approach to providing permanent sterilization within a reproductive justice framework that recognizes that all women have a right to pursue and to prevent pregnancy.

  16. Committee Opinion No 695 Summary: Sterilization of Women: Ethical Issues and Considerations.

    Science.gov (United States)

    2017-04-01

    Sterilization is the most common method of contraception among married couples, with nearly twice as many couples choosing female partner sterilization over male sterilization. Although sterilization is among the most straightforward surgical procedures an obstetrician-gynecologist performs, it is enormously complex when considered from a historical, sociological, or ethical perspective. Sterilization practices have embodied a problematic tension, in which some women who desired fertility were sterilized without their knowledge or consent, and other women who wanted sterilization to limit their family size lacked access to it. An ethical approach to the provision of sterilization must, therefore, promote access for women who wish to use sterilization as a method of contraception, but at the same time safeguard against coercive or otherwise unjust uses. This Committee Opinion reviews ethical issues related to the sterilization of women and outlines an approach to providing permanent sterilization within a reproductive justice framework that recognizes that all women have a right to pursue and to prevent pregnancy.

  17. Intra-Hospital Committee for Donation of Organs and Tissues for Transplant: ethical issues

    Directory of Open Access Journals (Sweden)

    Josiane Cappellaro

    2015-02-01

    Full Text Available The objective of this study was to demonstrate ethical aspects involved in the donation, collection and transplantation of organs and tissues through the experiences of workers in an intra-hospital committee for donation of organs and tissues for transplant. Exploratory qualitative research developed with eleven health workers. Data collection was performed at a university hospital in Pelotas, RS, Brazil, in the period of January-March 2010, through interviews. Data analysis resulted in the following categories: understanding of brain death diagnosis as an ethical issue; and, ethical issues experienced by workers in the relationship established with the family. It was concluded that such situations instigate workers to reflect on their attitudes, values, and their role as a health team member and protector of lives.

  18. AWARENESS OF MEDICAL SPECIALISTS AND PATIENTS IN BULGARIA OF ETHICS COMMITTEES AND THE BENEFITS OF THEIR WORK

    Directory of Open Access Journals (Sweden)

    Neli Gradinarova

    2018-02-01

    Full Text Available In today’s healthcare, the role of morality emerges to the forefront as a result of the high degree of uncertainty in our modern environment. Ethically responsible behaviour is therefore perceived as a prerequisite for preventing and counteracting a number of moral risks in society. With regard to moral hazard and responsibility, ethical codes represent a rational control mechanism, lowering the extent of the probability of moral peril. Ethics committees are also founded based on such ethical codes, the purpose of such committees being the proclamation and observation of the principles and norms set forth. At the healthcare institutions of the Republic of Bulgaria, ethics committees are established that are based on the principles of medical ethics and medical law. The significance with which ethics committees are charged regarding the sustainable development of the healthcare system consists of protecting the patients, the medical professionals and the institution itself. Awareness of the significance, functions and benefits of ethics committees and their impact on the medical practice and patients in Bulgaria is, however, insufficiently low. In a questionnaire survey conducted among 149 medical specialists employed at three medical establishments for hospital care in the country, and 269 patients under treatment at them, at being asked “Do you think that ethics committees contribute to protecting and respecting patients’ rights?”, 26.2% of the respondents among the medical professionals replied that they are not sure, while 25.7% of did not provide an answer to the question thus asked due to being unfamiliar with ethics committees as an institutionalized body and their functions. The analysis of the results of the abovementioned survey among medical professionals and patients evidences a low level of awareness of the ethics committees and their work on the territory of the Republic of Bulgaria. It is essential for healthcare

  19. Doing the right thing! A model for building a successful hospital-based ethics committee in Nunavut

    Directory of Open Access Journals (Sweden)

    Madeleine Cole

    2013-08-01

    Full Text Available Background. There exists a need throughout the North to increase capacity to address issues of health ethics and for community members to better understand and share their perspectives on this topic. Ethics comes down to weighing rights and wrongs, evaluating differing needs and understandings, acknowledging the many shades of grey and doing our best to come up with the just, fair and moral approach to the question at hand. Northern regions must collaborate to share capacity, successes and experiences in order to meet the unique needs of northern health care institutions and move forward on this issue. While guidelines for ethical research with indigenous populations exist, little has been published about an Inuit approach to health ethics more broadly. Design . To fill a critical need and to meet accreditation standards, the Qikiqtani General Hospital (QGH in Iqaluit, Nunavut, Canada, is in the process of building an Ethics Committee. Capitalizing on partnerships with other bodies both in northern and southern Canada has proved an efficient and effective way to develop local solutions to challenges that have been experienced both at QGH and other jurisdictions. Methods . The Ottawa Hospital Ethics Office and the active ethics committee at Stanton General Hospital in Yellowknife, NT, contributed expertise and experience, and helped provide some direction for the QGH ethics committee. At the local level, based on our shared commitment to health care ethics, the Qaujigiartiit Health Research Centre is an invaluable partner whose parallel efforts to develop a northern Health Research Ethics Board (REB gives great synergy to the QGH Ethics Committee. Results . Passion and commitment, as well as administrative support and endorsement from health care leaders, are the aspects of successful initiatives that we have identified to date. Using the information from both the experiences of other partners, as well as information gathered at a retreat held in

  20. Doing the right thing! A model for building a successful hospital-based ethics committee in Nunavut.

    Science.gov (United States)

    Cole, Madeleine; Healey, Gwen

    2013-01-01

    There exists a need throughout the North to increase capacity to address issues of health ethics and for community members to better understand and share their perspectives on this topic. Ethics comes down to weighing rights and wrongs, evaluating differing needs and understandings, acknowledging the many shades of grey and doing our best to come up with the just, fair and moral approach to the question at hand. Northern regions must collaborate to share capacity, successes and experiences in order to meet the unique needs of northern health care institutions and move forward on this issue. While guidelines for ethical research with indigenous populations exist, little has been published about an Inuit approach to health ethics more broadly. To fill a critical need and to meet accreditation standards, the Qikiqtani General Hospital (QGH) in Iqaluit, Nunavut, Canada, is in the process of building an Ethics Committee. Capitalizing on partnerships with other bodies both in northern and southern Canada has proved an efficient and effective way to develop local solutions to challenges that have been experienced both at QGH and other jurisdictions. The Ottawa Hospital Ethics Office and the active ethics committee at Stanton General Hospital in Yellowknife, NT, contributed expertise and experience, and helped provide some direction for the QGH ethics committee. At the local level, based on our shared commitment to health care ethics, the Qaujigiartiit Health Research Centre is an invaluable partner whose parallel efforts to develop a northern Health Research Ethics Board (REB) gives great synergy to the QGH Ethics Committee. Passion and commitment, as well as administrative support and endorsement from health care leaders, are the aspects of successful initiatives that we have identified to date. Using the information from both the experiences of other partners, as well as information gathered at a retreat held in Iqaluit in September 2011, we are working to develop a

  1. 75 FR 4830 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

    Science.gov (United States)

    2010-01-29

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES..., CDC, regarding a broad range of public health ethics questions and issues arising from programs...

  2. "The Project Cannot Be Approved in Its Current Form": Feminist Visual Research Meets the Human Research Ethics Committee

    Science.gov (United States)

    Pitt, Penelope

    2014-01-01

    This article reflects on a university human research ethics committee's unease regarding a feminist visual pilot study within the field of education. The small exploratory study proposed to explore a migrant mother's production of her son's identity through her family photograph collection. The committee requested substantial…

  3. Using the Emanuel et al. framework to assess ethical issues raised by a biomedical research ethics committee in South Africa.

    Science.gov (United States)

    Tsoka-Gwegweni, Joyce M; Wassenaar, Douglas R

    2014-12-01

    The Emanuel, Wendler, and Grady framework was designed as a universal tool for use in many settings including developing countries. However, it is not known whether the work of African health research ethics committees (RECs) is compatible with this framework. The absence of any normative or empirical weighting of the eight principles within this framework suggests that different health RECs may raise some ethical issues more frequently than others when reviewing protocols. We used the Emanuel et al. framework to assess, code, and rank the most frequent ethical issues considered by a biomedical REC during review of research protocols for the years 2008 to 2012. We extracted data from the recorded minutes of a South African biomedical REC for the years 2008 to 2012, designed the data collection sheet according to the Emanuel et al. framework, and removed all identifiers during data processing and analysis. From the 98 protocols that we assessed, the most frequent issues that emerged were the informed consent, scientific validity, fair participant selection, and ongoing respect for participants. This study represents the first known attempt to analyze REC responses/minutes using the Emanuel et al. framework, and suggests that this framework may be useful in describing and categorizing the core activities of an REC. © The Author(s) 2014.

  4. Evaluation of clinical trials by Ethics Committees in Germany: Experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA

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    Russ, Hagen

    2009-07-01

    Full Text Available The review of requests for a positive opinion of the ethics committees (application procedure as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12th Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation.With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee, the type and frequency of formal and content-related objections to applications according to § 7 of the German Good Clinical Practice (GCP Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I–IV studies submitted between January and December 2007 to 40 ethics committees were evaluated.This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

  5. Evaluation of clinical trials by Ethics Committees in Germany: experience of applicants with the review of requests for opinion of the Ethics Committees - results of a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA).

    Science.gov (United States)

    Russ, Hagen; Busta, Susanne; Riedel, Axel; Zöllner, Gereon; Jost, Bertfried

    2009-07-16

    The review of requests for a positive opinion of the ethics committees (application procedure) as a requirement to start a clinical trial in Germany has been completely redesigned with the transposition of EU Directive 2001/20/EC in the 12(th) Amendment of the German Medicines Act in August 2004. The experience of applicants (sponsors, legal representatives of sponsors in the EU and persons or organizations authorized by the sponsors to make the application, respectively) in terms of interactions with the ethics committees in Germany has been positive overall, especially with respect to ethics committee adherence to the statutory timelines applicable for review of requests. However, inconsistencies between ethics committees exist in terms of the form and content of the requirements for application documents and their evaluation. With the objective of further improving both the quality of applications and the evaluation of those applications by ethics committees, a survey among members of the German Association of Research-Based Pharmaceutical Companies (VFA) was conducted from January to April 2008. Based on reasoned opinions issued by the respective ethics committee in charge of the coordinating principal investigator (coordinating ethics committee), the type and frequency of formal and content-related objections to applications according to section sign 7 of the German Good Clinical Practice (GCP) Regulation were systematically documented, and qualitative and quantitative analyses performed. 21 out of 44 members of the VFA participated in the survey. 288 applications for Phase I-IV studies submitted between January and December 2007 to 40 ethics committees were evaluated. This survey shows that about one in six applications is incomplete and has formal and/or content objections, respectively, especially those that pertain to documents demonstrating the qualification of the investigator and/or suitability of the facilities. These objections are attributable to

  6. 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

  7. A Hospital-Based Committee of Moral Philosophy to Revive Ethics.

    Science.gov (United States)

    Illy, Margaux; Le Coz, Pierre; Mege, Jean-Louis

    2017-08-15

    The Méditerranée Infection Foundation's primary goal is supporting a research hospital for the treatment of infectious diseases in Marseille. The main objective of this innovative center is to understand the mechanisms of contagion and face them. The Foundation will include a committee on moral philosophy that will accompany and supervise biomedical research. This is not a conventional ethics committee, frequently giving rise to a board's bureaucratic excesses, which might slow down creative biomedical clinical research without necessarily restricting abuses. Moral philosophy, however, can handle contemporary biomedical issues. In all its diversity, this discipline is able to enrich the debate on medical issues, thanks to many philosophical currents such as deontological ethics and consequentialism. The purpose of this committee is therefore to advance reflection on the bioethical issues encountered in biomedical research in infectious diseases, while respecting the precepts of moral philosophy. © The Author 2017. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.

  8. [Bioethical Approach for Nursing Research -Focused on the Use of Research Ethics Committees].

    Science.gov (United States)

    Jeong, Ihn Sook

    2015-06-01

    This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.

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

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    Klaus Rose

    2015-05-01

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

  10. Impact of three years training on operations capacities of research ethics committees in Nigeria.

    Science.gov (United States)

    Folayan, Morenike Oluwatoyin; Adaranijo, Aisha; Durueke, Florita; Ajuwon, Ademola; Adejumo, Adebayo; Ezechi, Oliver; Oyedeji, Kola; Akanni, Olayide

    2014-04-01

    This paper describes a three-year project designed to build the capacity of members of research ethics committes to perform their roles and responsibilities efficiently and effectively. The project participants were made up of a cross-section of the membership of 13 Research Ethics Committees (RECs) functioning in Nigeria. They received training to develop their capacity to evaluate research protocols, monitor trial implementation, provide constructive input to trial staff, and assess the trial's success in promoting community engagement in the research. Following the training, technical assistance was provided to participants on an ongoing basis and the project's impacts were assessed quantitatively and qualitatively. Results indicate that sustained investment in capacity building efforts (including training, ongoing technical assistance, and the provision of multiple tools) improved the participants' knowledge of both the ethical principles relevant to biomedical research and how effective REC should function. Such investment was also shown to have a positive impact on the knowledge levels of other RECs members (those who did not receive training) and the overall operations of the RECs to which the participants belonged. Building the capacity of REC members to fulfill their roles effectively requires sustained effort and investment and pays off by enabling RECs to fulfill their essential mission of ensuring that trials are conducted safely and ethically. © 2012 John Wiley & Sons Ltd.

  11. The role of religious beliefs in ethics committee consultations for conflict over life-sustaining treatment.

    Science.gov (United States)

    Bandini, Julia I; Courtwright, Andrew; Zollfrank, Angelika A; Robinson, Ellen M; Cadge, Wendy

    2017-06-01

    Previous research has suggested that individuals who identify as being more religious request more aggressive medical treatment at end of life. These requests may generate disagreement over life-sustaining treatment (LST). Outside of anecdotal observation, however, the actual role of religion in conflict over LST has been underexplored. Because ethics committees are often consulted to help mediate these conflicts, the ethics consultation experience provides a unique context in which to investigate this question. The purpose of this paper was to examine the ways religion was present in cases involving conflict around LST. Using medical records from ethics consultation cases for conflict over LST in one large academic medical centre, we found that religion can be central to conflict over LST but was also present in two additional ways through (1) religious coping, including a belief in miracles and support from a higher power, and (2) chaplaincy visits. In-hospital mortality was not different between patients with religiously versus non-religiously centred conflict. In our retrospective cohort study, religion played a variety of roles and did not lead to increased treatment intensity or prolong time to death. Ethics consultants and healthcare professionals involved in these cases should be cognisant of the complex ways that religion can manifest in conflict over LST. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  12. Identifying structures, processes, resources and needs of research ethics committees in Egypt

    Directory of Open Access Journals (Sweden)

    Sleem Hany

    2010-06-01

    Full Text Available Abstract Background Concerns have been expressed regarding the adequacy of ethics review systems in developing countries. Limited data are available regarding the structural and functional status of Research Ethics Committees (RECs in the Middle East. The purpose of this study was to survey the existing RECs in Egypt to better understand their functioning status, perceived resource needs, and challenges. Methods We distributed a self-administered survey tool to Egyptian RECs to collect information on the following domains: general characteristics of the REC, membership composition, ethics training, workload, process of ethics review, perceived challenges to effective functioning, and financial and material resources. We used basic descriptive statistics to evaluate the quantitative data. Results We obtained responses from 67% (12/18 of the identified RECs. Most RECs (10/12 have standard operating procedures and many (7/12 have established policies to manage conflicts of interests. The average membership was 10.3 with a range from 7-19. The predominant member type was physicians (69.5% of all of the REC members with little lay representation (13.7%. Most RECs met at least once/month and the average number of protocols reviewed per meeting was 3.8 with a range from 1-10. Almost three-quarters of the members from all of the 12 RECs indicated they received some formal training in ethics. Regarding resources, roughly half of the RECs have dedicated capital equipment (e.g., meeting room, computers, office furniture, etc; none of the RECs have a formal operating budget. Perceived challenges included the absence of national research ethics guidelines and national standards for RECs and lack of ongoing training of its members in research ethics. Conclusion Our study documents several areas of strengths and areas for improvements in the operations of Egyptian RECs. Regarding strengths, many of the existing RECs meet frequently, have a majority of members

  13. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review

    NARCIS (Netherlands)

    Lent, M.J. van; Rongen, G.A.; Out, H.J.

    2014-01-01

    BACKGROUND: Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC

  14. An evaluation of a data linkage training workshop for research ethics committees.

    Science.gov (United States)

    Tan, Kate M; Flack, Felicity S; Bear, Natasha L; Allen, Judy A

    2015-03-04

    In Australia research projects proposing the use of linked data require approval by a Human Research Ethics Committee (HREC). A sound evaluation of the ethical issues involved requires understanding of the basic mechanics of data linkage, the associated benefits and risks, and the legal context in which it occurs. The rapidly increasing number of research projects utilising linked data in Australia has led to an urgent need for enhanced capacity of HRECs to review research applications involving this emerging research methodology. The training described in this article was designed to respond to an identified need among the data linkage units in the Australian Population Health Research Network (PHRN) and HREC members in Australia. Five one-day face to face workshops were delivered in the study period to a total of 98 participants. Participants in the workshops represented all six categories of HREC membership composition listed in the National Health and Medical Research Centres' (NHMRC) National Statement on Ethical Conduct in Human Research. Participants were assessed at three time points, prior to the training (T1), immediately after the training (T2) and 8 to 17 months after the training (T3). Ninety participants completed the pre and post questionnaires; 58 of them completed the deferred questionnaire. Participants reported significant improvements in levels of knowledge, understanding and skills in each of the eight areas evaluated. The training was beneficial for those with prior experience in the area of ethics and data linkage as well as those with no prior exposure. Our preliminary work in this area demonstrates that the provision of intensive face to face ethics training in data linkage is feasible and has a significant impact on participant's confidence in reviewing HREC applications.

  15. Establishment and work of ethics committees in central and eastern European countries.

    Science.gov (United States)

    Glasa, Jozef

    2002-01-01

    The genuine reform efforts in medicine and health care in Central and East European (CEE) countries have continued to pose important and thought-provoking challenges to the newly reborn disciplines of medical ethics (or bioethics). They are embodied in the bulk of new ethical problems, concepts and quandaries brought about by the developments, changes, clashes, and "real life" issues of the CEE countries' health care systems and biomedical sciences. Certain part, quite variable from country to country, of this bio-ethical endeavour has been confined to the work and activities of ethics committees (ECs) or similar bodies. They have emerged in varying number, shape, composition, competence, legal status, responsibility and time of appearance, in almost all transition countries of CEE. They may be considered as a kind of "field workplaces" of medical ethics/bioethics within the countries' HCSs or biomedical research structures. Despite some shortcomings and drawbacks, a lot has already been achieved. In some countries the progress has been quick and systematic. The major pitfalls were mostly due to the missing, weak or unclear legal backing of ECs' establishment and work; lack of education and training of their members; insufficient support from health care administrators; misconceptions concerning their mission, procedures, scope of responsibility, and reporting; insufficient or missing funding; low profile societal esteem for ECs' work; but some drawbacks were due also to the underdeveloped 'dialogic' culture of the impartial discussion and democratic discourse in the 'post-totalitarian' CEE transition countries. The future of ECs in CEE will be connected to the countries' integration and harmonization efforts towards research, health systems, and other international structures in Europe and beyond. This should need an extensive and non-discriminatory international partnership, exchange and co-operation.

  16. Health Research Ethics Committees in South Africa 12 years into democracy.

    Science.gov (United States)

    Moodley, Keymanthri; Myer, Landon

    2007-01-25

    Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs) in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56%) are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

  17. Health Research Ethics Committees in South Africa 12 years into democracy

    Directory of Open Access Journals (Sweden)

    Myer Landon

    2007-01-01

    Full Text Available Abstract Background Despite the growth of biomedical research in South Africa, there are few insights into the operation of Research Ethics Committees (RECs in this setting. We investigated the composition, operations and training needs of health RECs in South Africa against the backdrop of national and international guidelines. Methods The 12 major health RECs in South Africa were surveyed using semi-structured questionnaires that investigated the composition and functions of each REC as well as the operational issues facing committees. Results Health RECs in SA have an average of 16 members and REC members are predominantly male and white. Overall, there was a large discrepancy in findings between under-resourced RECs and well resourced RECs. The majority of members (56% are scientists or clinicians who are typically affiliated to the same institution as the health REC. Community representatives account for only 8% of membership. Training needs for health REC members varied widely. Conclusion Most major health RECs in South Africa are well organized given the resource constraints that exist in relation to research ethics in developing countries. However, the gender, racial and occupational diversity of most of these RECs is suboptimal, and most RECs are not constituted in accordance with South African guidelines. Variability in the operations and training needs of RECs is a reflection of apartheid-entrenched influences in tertiary education in SA. While legislation now exists to enforce standardization of research ethics review systems, no provision has been made for resources or capacity development, especially to support historically-disadvantaged institutions. Perpetuation of this legacy of apartheid represents a violation of the principles of justice and equity.

  18. Decisions by Finnish Medical Research Ethics Committees: A Nationwide Study of Process and Outcomes.

    Science.gov (United States)

    Hemminki, Elina; Virtanen, Jorma I; Regushevskaya, Elena

    2015-10-01

    Review by research ethics committees (RECs) is the key in medical research regulation. Data from meeting notes and project summaries were abstracted from all projects submitted in 2002 (n = 1,004) and 2007 (n = 1,045) to the official medical RECs in Finland. Data from consecutive submissions were combined per project. When comparing RECs, logistic regression was used to adjust for application characteristics. The number of projects handled varied notably by REC. In the first handling, 85% of applications in 2002 and 77% in 2007 were approved, while 13% and 20% were tabled. For 61% of the projects, the review time was 89 days, and 6% had 6 months or longer. The variation by REC in approval rates, number of handlings, or long review times was not explained by project characteristics. In the last handling, 94% of the projects in both years were approved or concluded not to need a statement from that REC. The most common reason for tabling or not approving an application was patient autonomy, usually centered on the patient leaflet. The next most common reasons were requests for further information and dissatisfaction with the scientific aspects of the project. The reasons classified as "ethics" in the narrow sense were rare. The REC focus was to assure that researchers follow the various rules on medical research and to improve the quality of research and project documents. REC considerations could be divided into decisions based on ethics and recommendations covering other aspects. © The Author(s) 2015.

  19. [Perception and satisfaction of main researchers on the management of a Clinical Research Ethics Committee].

    Science.gov (United States)

    Vilardell Navarro, N; Redondo-Capafons, S; Giménez, N; Quintana, S

    2013-01-01

    To analyze the main researchers (MR) perception and satisfaction associated to face-to-face project presentation as well as Clinical Research Ethics Committee (CREC) functions related to administrative and advisement aspects. Descriptive study performed during nine months (January to September 2011) through voluntary participation questionnaire given to MR who assisted to CREC meetings. The questionnaire contained a numeric range (1-10) and open issues to evaluate the presentation process, the satisfaction of CREC functions considering bureaucratic aspects, ethics, scientific-methodological, legal recommendations and its global function. Descriptive statistics and Student test were performed. The questionnaire was answered by 36 (95%) of total MR. Average score obtained in the evaluation of face-to-face study presentation was 9.2 (SD 0.9). In reference to legal issues an average punctuation of 7.1 (DE 0.4) was obtained, whereas ethics and scientific-methodological aspects scored 8.2 (DE 0.2 and 0.4). Global average evaluation about CREC tasks was 8.6 (SD 1.0). A positive assessment related to attend to the project presentation was made for 22 (61%) of the MR. The study showed a high satisfaction of CREC operation and a high evaluation of face-to-face project presentation. There were detected further improvement aspects to optimize CREC meetings, taking into account the effort developed by MR and CREC members. Copyright © 2013 SEFH. Published by AULA MEDICA. All rights reserved.

  20. The reporting of research ethics committee approval and informed consent in otolaryngology journals.

    Science.gov (United States)

    Murphy, S; Nolan, C; O'Rourke, C; Fenton, J E

    2015-02-01

    Medical research involving human subjects must follow ethical standards as outlined in the Declaration of Helsinki of the World Medical Association. The aim of this study was to assess the frequency of reporting of informed consent and regional ethical committee (REC) approval in all reports of trials published in the major European Otolaryngology journals. Review of all clinical research articles published online in the calendar year 2012. Three leading European Otolaryngology journals. Clinical Otolaryngology, The Journal of Laryngology and Otology and The European Achieves of Oto-Rhino-Laryngology. Evaluate the incidence of reporting of REC approval and informed consent. Of the 767 articles reviewed, 401 met the inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research which require ethical approval). 49.9% lacked a statement of REC approval and 42.9% lacked disclosure of informed consent. Articles that did not state REC approval were associated with not stating informed consent (P < 0.05). Articles that lack explicit statements of REC approval and informed consent are frequent and continue to be published in major otolaryngology journals. © 2014 John Wiley & Sons Ltd.

  1. Ethics Review Committee approval and informed consent: an analysis of biomedical publications originating from Sri Lanka

    Directory of Open Access Journals (Sweden)

    Siriwardhana Chesmal

    2008-02-01

    Full Text Available Abstract Background International guidelines on research have focused on protecting research participants. Ethical Research Committee (ERC approval and informed consent are the cornerstones. Externally sponsored research requires approval through ethical review in both the host and the sponsoring country. This study aimed to determine to what extent ERC approval and informed consent procedures are documented in locally and internationally published human subject research carried out in Sri Lanka. Methods We obtained ERC approval in Sri Lanka and the United Kingdom. Theses from 1985 to 2005 available at the Postgraduate Institute of Medicine (PGIM library affiliated to the University of Colombo were scrutinised using checklists agreed in consultation with senior research collaborators. A Medline search was carried out with MeSH major and minor heading 'Sri Lanka' as the search term for international publications originating in Sri Lanka during 1999 to 2004. All research publications from CMJ during 1999 to 2005 were also scrutinized. Results Of 291 theses, 34% documented ERC approvals and 61% documented obtaining consent. From the international journal survey, 250 publications originated from Sri Lanka of which only 79 full text original research publications could be accessed electronically. Of these 38% documented ERC approval and 39% documented obtaining consent. In the Ceylon Medical Journal 36% documented ERC approval and 37% documented obtaining consent. Conclusion Only one third of the publications scrutinized recorded ERC approval and procurement of informed consent. However, there is a positive trend in documenting these ethical requirements in local postgraduate research and in the local medical journal.

  2. Ethics committees in Italy: a survey on a sample of oncologists.

    Science.gov (United States)

    Mosconi, Paola; Apolone, Giovanni; Cattaneo, Giovanna; Pomodoro, Livia; Garattini, Silvio

    2003-01-01

    The mission of physicians and the purpose of clinical research may give rise to a conflict between medical ethics and human rights. All the recommendations, directives and laws regarding experimental interventions require a formal protocol, approval from an ethics committee (EC), and written informed consent from potential participants. In Italy new guidelines on handling submissions to EC were published in 1998. One year later, there was a feeling among people involved in EC activities that the immediate impact of the new rules (ie, decentralization and emphasis on pharmacological aspects of the studies) was negative. A prospective study was launched to evaluate oncologists' opinions on Italian EC functioning. A questionnaire was administered twice to 110 oncologists involved in two multicenter trials. Nine questions were included regarding the following aspects: presence of an EC at hospital level, personal experience with an EC, average time required for the evaluation of proposals submitted, and level of satisfaction with important functions of the EC. Responses were received from 93 (first survey) and 69 (second survey) clinicians. In both surveys clinicians reported they were satisfied with the scientific and ethical aspects of EC functioning but dissatisfied with educational activities and training as well as bureaucratic and clerical requirements. At the second survey, the mean time required for evaluation after the submission of a study protocol was about 2.4 months and the level of dissatisfaction was still high for some critical aspects such as bureaucracy (44%) and educational activities and training (64%). Analysis of the change over time documented small differences (from -8% to +7%) in all aspects evaluated. Despite the limitations of the present study, ie, the small sample size and the intrinsic characteristics of the Italian setting, the findings add empirical evidence regarding the functioning of local EC and clinical researchers' opinions. This

  3. [Update of the work of the ethics research in evaluating genetic research and its role as an external ethics committee biobank].

    Science.gov (United States)

    Alfonso Farnós, Iciar; Hernández Gil, Arantza; Rodríguez Velasco, María

    2013-01-01

    Research on human genome and its applications open great perspectives to improve human beings' health. However, these advances must never endanger the respect of dignity, freedom and rights of the participants in medical research, assuring prohibition of any way of discrimination because of genetic features. The Independent Research Boards (IRB), responsible for safeguarding rights, safety and well-being of the subjects taking part in the biomedical research, assess independently submitted genetic studies, clinical trials whose primary objective is obtaining genetic information and genetic sub-studies of clinical trials with drugs. Biobanks, as safeguarding means to preserve biological samples in suitable quality conditions, must be assigned to two external committees, a scientific one and an ethics one. External ethics committees of biobanks have to make the ethical assessment of the submissions of samples transfers and associated data, in order to carry out research projects. On the other hand, they have to advise biobanks on the compliance of ethical and legal principles, which, in many committees, has turned into the performance of informed consent forms which are in accordance with current laws.

  4. Activity of Ethics Committees in Europe on issues related to clinical trials in paediatrics: Results of a survey

    Czech Academy of Sciences Publication Activity Database

    Altavilla, A.; Giaquinto, C.; Giocanti, D.; Manfredi, C.; Aboulker, J.-P.; Bartoloni, F.; Cattani, E.; Giudice, M. L.; Mellado Peňa, M.J.; Nagler, R.; Peterson, C.; Vajnerová, Olga; Bonifazi, F.; Ceci, A.

    2009-01-01

    Roč. 11, 1-2 (2009), s. 79-87 ISSN 1389-2827 Grant - others:EC(XE) LSHBCT-2005-005126 Institutional research plan: CEZ:AV0Z50110509 Keywords : ethic committees * clinical trials * pediatrics Subject RIV: FP - Other Medical Disciplines

  5. [Independent ethics committees for clinical research in Argentina. An evaluation and a system to guarantee their independence].

    Science.gov (United States)

    Gonorazky, Sergio E

    2008-01-01

    The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT) requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the assumed autonomy of the former can be reduced to merely a relationship of "service provider-customer". The Institutional Review Board of the Mar del Plata s Community Hospital has evaluated, between 2005 and 2006, thirty three research protocols (with their corresponding information sheets for patients and informed consent forms) previously approved by a non-institutional Independent Ethics Committee. The median number of objections made by the Institutional Review Board, which prompted the previously mentioned protocols to be modified in order to be approved, was of three per protocol. In other words, the accreditation of an Independent Ethics Committee requires a system that guarantees actual independence from the sponsors and/or researchers, as well as management control mechanisms that may lead them into an eventual loss of accreditation. Several measures are proposed in order to correct the deficiencies of the present system.

  6. 76 FR 57744 - Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)-Ethics...

    Science.gov (United States)

    2011-09-16

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control and Prevention (CDC)--Ethics Subcommittee (ES) Correction: This notice was published in the Federal Register on September 8, 2011, Volume 76, Number 174...

  7. 75 FR 7483 - Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention-Ethics...

    Science.gov (United States)

    2010-02-19

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Centers for Disease Control and Prevention Advisory Committee to the Director (ACD), Centers for Disease Control (CDC) and Prevention--Ethics Subcommittee (ES); Correction AGENCY: Centers for Disease Control and Prevention (CDC), HHS. ACTION: Notice of meeting; meeting...

  8. Ethics review of studies during public health emergencies - the experience of the WHO ethics review committee during the Ebola virus disease epidemic.

    Science.gov (United States)

    Alirol, Emilie; Kuesel, Annette C; Guraiib, Maria Magdalena; de la Fuente-Núñez, Vânia; Saxena, Abha; Gomes, Melba F

    2017-06-26

    Between 2013 and 2016, West Africa experienced the largest ever outbreak of Ebola Virus Disease. In the absence of registered treatments or vaccines to control this lethal disease, the World Health Organization coordinated and supported research to expedite identification of interventions that could control the outbreak and improve future control efforts. Consequently, the World Health Organization Research Ethics Review Committee (WHO-ERC) was heavily involved in reviews and ethics discussions. It reviewed 24 new and 22 amended protocols for research studies including interventional (drug, vaccine) and observational studies. WHO-ERC provided the reviews within on average 6 working days. The WHO-ERC often could not provide immediate approval of protocols for reasons which were not Ebola Virus Disease specific but related to protocol inconsistencies, missing information and complex informed consents. WHO-ERC considerations on Ebola Virus Disease specific issues (benefit-risk assessment, study design, exclusion of pregnant women and children from interventional studies, data and sample sharing, collaborative partnerships including international and local researchers and communities, community engagement and participant information) are presented. To accelerate study approval in future public health emergencies, we recommend: (1) internally consistent and complete submissions with information documents in language participants are likely to understand, (2) close collaboration between local and international researchers from research inception, (3) generation of template agreements for data and sample sharing and use during the ongoing global consultations on bio-banks, (4) formation of Joint Scientific Advisory and Data Safety Review Committees for all studies linked to a particular intervention or group of interventions, (5) formation of a Joint Ethics Review Committee with representatives of the Ethics Committees of all institutions and countries involved to

  9. Are Research Ethics Committees Prepared for Community-Based Participatory Research?

    Science.gov (United States)

    Tamariz, Leonardo; Medina, Heidy; Taylor, Janielle; Carrasquillo, Olveen; Kobetz, Erin; Palacio, Ana

    2015-12-01

    Community-based participatory research (CBPR) is challenging to research ethics committees (RECs). We reviewed the REC preparedness when reviewing CBPR projects. We searched the MEDLINE database and included qualitative studies of CBPR researchers or REC members about their experiences with RECs. The search yielded 107 studies, of which 10 met our criteria. Barriers were that the community is not prepared to conduct research, the reluctance of RECs to work outside the university, the difficulty RECs have understanding CBPR, and that REC forms evaluate individual rather than community risk. Facilitators were having a CBPR expert as an REC member and educating RECs. Therefore, RECs are not prepared to evaluate CBPR projects leading to unnecessary delays in the approval process. © The Author(s) 2015.

  10. Overall Assessment of Human Research and Ethics Committees in the United Arab Emirates.

    Science.gov (United States)

    Abdulrahman, Mahera; Nair, Satish Chandrasekhar

    2017-04-01

    Growing demand for human health research in the United Arab Emirates (UAE) has prompted the need to develop a robust research ethics oversight. Examination of the structure, function, and practices of the human research ethics committees (HRECs), followed by evaluation of standards for measuring research output, was conducted. Results indicate that among the HRECs, 90% followed International Council for Harmonization-Good Clinical Practice guidelines, 66.6% have been in operation for more than 5 years, 95% reviewed proposals within 8 weeks, and 56% reviewed for scientific merit apart from ethics. However, systems to recognize accomplishments of researchers, funding transparency, and adverse event reporting were deployed in less than 30% of all HRECs. Research was incorporated into the vision and mission statements of many (65%) organizations. Research publications, collaborations, and recognitions were used to measure research output and report key performance indicators. In spite, resources to generate research output such as dedicated budget (20%), support staff (20%), and continuous training and mentoring program for medical residents (15%) and HREC members (25%) were somehow lacking. HREC structure and operations in the UAE are similar to other regions of the world. Systems to conduct research and report outcomes are defined in the UAE. Regulatory legislation and allocation of resources to support the clinical research enterprise will not only help to meet growing demand for clinical trials but also transform the quality of patient care in the UAE. It is anticipated that the results of this study will benefit investigators, regulators, pharmaceutical sponsors, and the policy makers in the region.

  11. Fair inclusion of men and women in Australian clinical research: views from ethics committee chairs.

    Science.gov (United States)

    Ballantyne, Angela J; Rogers, Wendy A

    2008-06-02

    To explore the role played by human research ethics committees (HRECs) with regard to the fair inclusion of men and women in Australian clinical research. Semi-structured face-to-face and telephone interviews with 25 chairs (or their nominees) of Australian HRECs between 9 June 2006 and 24 January 2007. Chairs' views about the role of HRECs in identifying sex discrimination, monitoring the inclusion of men and women in clinical research, and interpreting and applying National Health and Medical Research Council (NHMRC) guidelines relating to fair inclusion in research. In general, HRECs do not take an active role in monitoring the sex of research participants. They do not ask for or often receive information about the sex of participants. Most HREC chairs did not believe that sex discrimination in research is currently a significant or widespread problem, and were confident that their committees would be able to identify arbitrary exclusion of either men or women from research. However, many chairs expressed a lack of familiarity with debates about sex equity in research. Most chairs were unaware that anti-sex-discrimination legislation could apply to research. "Fair inclusion" was interpreted in a number of ways by chairs, but most frequently that the sex balance among research participants should reflect the sex distribution in the community of the condition under investigation. Chairs said their committees would be reluctant to reject a research protocol on the grounds that the sex balance among participants was perceived to be unfair. Views about, and expertise on, sex equity in research vary among chairs of HRECs. Many HRECs require further guidance about the appropriate standards for fair inclusion of men and women in Australian clinical research.

  12. Young people's views about the purpose and composition of research ethics committees: findings from the PEARL qualitative study.

    Science.gov (United States)

    Audrey, Suzanne; Brown, Lindsey; Campbell, Rona; Boyd, Andy; Macleod, John

    2016-09-02

    Avon Longitudinal Study of Parents and Children (ALSPAC) is a birth cohort study within which the Project to Enhance ALSPAC through Record Linkage (PEARL) was established to enrich the ALSPAC resource through linkage between ALSPAC participants and routine sources of health and social data. PEARL incorporated qualitative research to seek the views of young people about data linkage, including their opinions about appropriate safeguards and research governance. In this paper we focus on views expressed about the purpose and composition of research ethics committees. Digitally recorded interviews were conducted with 48 participants aged 17-19 years. Participants were asked about whether medical research should be monitored and controlled, their knowledge of research ethics committees, who should sit on these committees and what their role should be. Interview recordings were fully transcribed and anonymised. Thematic analysis was undertaken, assisted by the Framework approach to data management. The majority of interviewees had little or no specific knowledge of ethics committees. Once given basic information about research ethics committees, only three respondents suggested there was no need for such bodies to scrutinise research. The key tasks of ethics committees were identified as monitoring the research process and protecting research participants. The difficulty of balancing the potential to inhibit research against the need to protect research participants was acknowledged. The importance of relevant research and professional expertise was identified but it was also considered important to represent wider public opinion, and to counter the bias potentially associated with self-selection possibly through a selection process similar to 'jury duty'. There is a need for more education and public awareness about the role and composition of research ethics committees. Despite an initial lack of knowledge, interviewees were able to contribute their ideas and balance

  13. An Evaluation of the Middle East Research Training Initiative Tool in Assessing Effective Functioning of Research Ethics Committees.

    Science.gov (United States)

    Jaoko, Walter; Bukusi, Elizabeth; Davis, Arlene M

    2016-10-01

    The effective functioning of a research ethics committee (REC) can be evaluated using self-assessment tools. The Middle East Research Ethics Training Initiative (MERETI) tool can be used by one member, typically the Chair, to score an REC. The consistency of these scores across several members of an REC has never been evaluated. This study examined whether results would be consistent irrespective of who conducts the assessment. One REC's effective functioning was assessed by several members ( n = 13). The Chair's scores were compared with scores of other members in relation to their duration of REC membership, research ethics training, gender, and employer's institutional affiliation to the REC. The Chair's overall score was higher than the other members' scores by 11%. No significant differences in scores were obtained in relation to duration of REC membership ( p = .72), interval since last research ethics training ( p = .94), and gender ( p = .27). The MERETI tool is thus consistent irrespective of who performs the assessment.

  14. Ethical issues of informed consent in malaria research proposals submitted to a research ethics committee in Thailand: a retrospective document review.

    Science.gov (United States)

    Adams, Pornpimon; Prakobtham, Sukanya; Limpattaracharoen, Chanthima; Suebtrakul, Sumeth; Vutikes, Pitchapa; Khusmith, Srisin; Wilairatana, Polrat; Adams, Paul; Kaewkungwal, Jaranit

    2017-08-14

    The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted to the Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures (study activities and specimen/data-collection process) to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase

  15. A Case-Study of the Resources and Functioning of Two Research Ethics Committees in Western India.

    Science.gov (United States)

    Chenneville, Tiffany; Menezes, Lynette; Kosambiya, Jayendrakumar; Baxi, Rajendra

    2016-12-01

    Assessing the resources and functioning of research ethics committees (RECs) in low-resource settings poses many challenges. We conducted a case study of two medical college RECs (A and B) in Western India utilizing the Research Ethics Committee Quality Assurance Self-Assessment Tool (RECQASAT) as well as in-depth interviews with representative members to evaluate REC effectiveness. REC A and B obtained 62% and 67% of allowable points on the RECQASAT. These scores together with findings from the in-depth interviews suggest the need for significant improvement in REC effectiveness particularly in the areas of membership and educational training, organizational aspects, recording minutes, communicating decisions, and REC resources. Developing evidence-based best practices and strengthening infrastructure are essential to enhancing REC efficacy in low-resource countries.

  16. An audit of the approval letters issued by Drugs Controller General of India to Ethics Committees in India.

    Science.gov (United States)

    Bhide, Shruti S; Katkar, Jahnavi V; Maurya, Mitesh; Gogtay, Nithya Jaideep; Thatte, Urmila M

    2016-01-01

    The present study is an audit of the communiqués issued by the Drugs Controller General of India [DCGI] to Ethics Committees [ECs] for content and directives after the mandatory notification of registration of Ethics Committees issued on 8 th February 2013. All letters were downloaded from the website of the Central Drugs Standard Control Organization [CDSCO] and evaluated for the date of issue, number of directives, domains covered by the directives [general instructions, administrative requirements and quorum requirements], median time to approval for registration and time elapsed between date of application and issue of the approval letter. There were a total of 1036 EC letters listed on the website, from which 854 [82.4%] could be downloaded. A working denominator of 841 was arrived at after discarding repeat letters and those that had an incorrect address. The state of Maharashtra had the highest number of ECs registered (209/841, 24.9%) followed by Gujarat [97/841, 11.5%) and Karnataka [96/841, 11.4%]. The number of directives within each letter ranged from 8-22. The overall time to approval was 77.5 [24-919] days and the time to approval between Institutional and Independent Ethics Committees was significantly different. The office of the DCGI had a very wide time range for approving registration of Ethics Committees that ranged from less than a month to more than two years. The quality and nature of the directives improved with time. As the country moves towards accreditation, letters issued by the DCGI should have uniformity. The large number of ECs in a single state and lack of even a single one in several others is something that needs to be addressed by policy makers.

  17. Phronesis: Beyond the Research Ethics Committee-A Crucial Decision-Making Skill for Health Researchers During Community Research.

    Science.gov (United States)

    Greeff, Minrie; Rennie, Stuart

    2016-04-01

    Health researchers conducting research in the community are often faced with unanticipated ethical issues that arise in the course of their research and that go beyond the scope of ethical approval by the research ethics committee. Eight expert researchers were selected through extreme intensity purposive sampling, because they are representative of unusual manifestations of the phenomenon related to their research in the community. They were selected to take part in a semi-structured focus group discussion on whether practical wisdom (phronesis) is used as a decision-making skill to solve unanticipated ethical issues during research in the community. Although the researchers were not familiar with the concept phronesis, it became obvious that it formed an integral part of their everyday existence and decision making during intervention research. They could balance research ethics with practical considerations. The capacity of practical wisdom as a crucial decision-making skill should be assimilated into a researcher's everyday reality, and also into the process of mentoring young researchers to become phronimos. Researchers should be taught this skill to handle unanticipated ethical issues. © The Author(s) 2016.

  18. Impact of the economic crisis on the activity of a clinical research ethics committee

    Directory of Open Access Journals (Sweden)

    Paula Arcenillas

    2014-11-01

    Full Text Available Purpose: Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT and observational studies (ES from the activity of an Research Ethics Committee (REC. Method: REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1 promoted by pharmaceutical industry, 2 by scientific societies with industry support, 3 by scientific societies with government support and 4 unfunding.Two periods were compared: pre-crisis (2003-2007 and crisis (2008-2012. Results: During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Conclusions: Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS.

  19. What doesn’t work with Phase IV studies? A real experience from an Ethics Committee

    Directory of Open Access Journals (Sweden)

    F. Grigoletto

    2013-05-01

    Full Text Available Phase IV studies are conducted in real-life conditions to expand the knowledge on the efficacy and safety of an approved drug. Carried out either in hospital or general practice setting, they can be distinguished in Phase IV trials and post-marketing surveillance studies. Limited information is available in Italy about their characteristics as the proportion of observational studies, the average size and the importance of the non-sponsored research. In order to investigate these and other features, we analysed 1,881 protocols presented to the Ethics Committee of a large size University Hospital in the decade 1999-2008. Out of the 188 (10% Phase IV studies, about three fourths were controlled clinical trials, 48.4% had an active drug and 16.0% a placebo as comparator; only 8.5% was presented as observational. Most of the Phase IV studies could be classifiable as Phase IIIb. The median sample size value was 200 patients, while the Phase III studies reported a median of 360 patients, this contradicting the “large-scale” characteristic of the Phase IV studies reported in the literature.

  20. A perinatal ethics committee on abortion: process and outcome in thirty-one cases.

    Science.gov (United States)

    La Puma, J; Darling, C M; Stocking, C B; Schiller, K

    1992-01-01

    The US Supreme Court's June 1992 decision to uphold most of Pennsylvania's law restricting access to abortion confirms that while abortion is still permitted in the US, it is being increasingly regulated. Individual institutions may, however, find ways to permit access to abortion. One hospital formed a mandatory, prospective perinatal ethics committee (PEC) in May 1987 to develop clinical guidelines with which to consider and decide requests by physicians for their patients seeking abortions. The authors obtained the consent of this PEC to study its membership, processes, case outcomes, and clinical decision making. Understanding PEC processes and outcomes may help other institutions to decide whether to institute similar mechanisms. Specifically, the investigators determined the backgrounds and abortion-related beliefs of PEC members and obstetric and gynecology department members, whether the PEC affects the number of abortions performed, how PEC members decide in individual cases, and whether requesting physicians find the PEC helpful. All eleven PEC members and 58 of the 65 medical staff ob/gyn physicians returned background surveys. Study results are presented. Overall, the PEC appeared to function as an affirming regulatory body for second-trimester, medically-indicated terminations and for certain personal choice terminations. Institutional interests were well-served by the PEC and with the assurance of informed consent, the interests of some patients were also well served.

  1. [Impact of the economic crisis on the activity of a clinical research ethics committee].

    Science.gov (United States)

    Redondo Capafons, S; Arcenillas, Paula; Giménez, Nuria; March López, Pablo; Soriano, Laura; Pla, Ramon; Quintana, Salvador

    2014-11-03

    Analyze the impact of economic and social crisis in volume and funding of clinical trials (CT) and observational studies (ES) from the activity of an Research Ethics Committee (REC). REC memories 2003-2012 were reviewed. Financing of evaluated projects, CT and OS were analyzed classifying them into four groups: 1) promoted by pharmaceutical industry, 2) by scientific societies with industry support, 3) by scientific societies with government support and 4) unfunding.Two periods were compared: pre-crisis (2003-2007) and crisis (2008-2012). During 10 studied years, 744 protocols were evaluated: a 71% of group 1, a 9% of group 2, a 3% of group 3 and a 17% was no funding. Regarding OS, 40%, 5,4%, 8,6% and 46% were the groups 1, 2, 3 and 4 respectively. Analyzing crisis versus pre-crisis period, statistically significant differences were observed in the decreasing of number of CT phase 2 and 3 and in the rising EO. Comparing crisis related to the pre-crisis period, the Group 4 increased statistically significantly. Evolution of total number of studies evaluated by REC tends to be maintained and even increased over time. REC maintains its activity and even increased at the expense of financing and unfunded OS. Copyright AULA MEDICA EDICIONES 2014. Published by AULA MEDICA. All rights reserved.

  2. Clinical research ethics review process in Lebanon: efficiency and functions of research ethics committees - results from a descriptive questionnaire-based study.

    Science.gov (United States)

    Atallah, David; Moubarak, Malak; El Kassis, Nadine; Abboud, Sara

    2018-01-11

    Clinical trials conducted in Lebanon are increasing. However, little is known about the performance of research ethics committees (RECs) in charge of reviewing the research protocols. This study aimed to assess the level of adherence to the ethics surrounding the conduct of clinical trials and perceptions of team members regarding roles of the RECs during the conduct of clinical trials in Lebanon. The research question was: Are RECs adherent to the ethics surrounding the conduct of clinical trials (chapters II and IV in 'Standards and Operational Guidance for Ethics Review of Health-related Research with Human Participants' in Lebanon?' This was a quantitative and descriptive questionnaire-based study conducted among RECs of university hospitals in Lebanon. The questionnaire had to be completed online and included general questions in addition to items reflecting the different aspects of a REC performance and effectiveness. All the questionnaire was assigned a total score of 175 points. General information and questions assigned point values/scores were analysed using descriptive statistics: frequency and percentage, mean score ± standard deviation. Ten RECs participated in the study (52 persons: four chairs, one vice-president, 47 ordinary members). Forty-seven (90.4%) had previous experience with clinical research and 30 (57.7%) had a diploma or had done a training in research ethics. Forty-one percent confirmed that they were required to have a training in research ethics. All RECs had a policy for disclosing and managing potential conflicts of interest for its members, but 71.8% of participants reported the existence of such a policy for researchers. Thirty-three point three percent reported that the RECs had an anti-bribery policy. The questionnaire mean score was 129.6 ± 22.3/175 points reflecting thus an excellent adherence to international standards. Inadequate training of REC members and the lack of anti-bribery policies should be resolved to

  3. Research ethics committee decision-making in relation to an efficient neonatal trial.

    Science.gov (United States)

    Gale, C; Hyde, M J; Modi, N

    2017-07-01

    Randomised controlled trials, a gold-standard approach to reduce uncertainties in clinical practice, are growing in cost and are often slow to recruit. We determined whether methodological approaches to facilitate large, efficient clinical trials were acceptable to UK research ethics committees (RECs). We developed a protocol in collaboration with parents, for a comparative-effectiveness, randomised controlled trial comparing two widely used blood transfusion practices in preterm infants. We incorporated four approaches to improve recruitment and efficiency: (i) point-of-care design using electronic patient records for patient identification, randomisation and data acquisition, (ii) short two-page information sheet; (iii) explicit mention of possible inclusion benefit; (iv) opt-out consent with enrolment as the default. With the support of the UK Health Research Authority, we submitted an identical protocol to 12 UK REC. RECs in the UK. Number of REC granting favourable opinions. The use of electronic patient records was acceptable to all RECs; one REC raised concerns about the short parent information sheet, 10 about inclusion benefit and 9 about opt-out consent. Following responses to queries, nine RECs granted a favourable final opinion and three rejected the application because they considered the opt-out consent process invalid. A majority of RECs in this study consider the use of electronic patient record data, short information sheets, opt-out consent and mention of possible inclusion benefit to be acceptable in neonatal comparative-effectiveness research. We identified a need for guidance for RECs in relation to opt-out consent processes. These methods provide opportunity to facilitate large randomised controlled trials. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

  4. Focus on the Activity of a Local Ethics Committee in Italy

    Directory of Open Access Journals (Sweden)

    Pamela Barbadoro

    2008-06-01

    Full Text Available

    Background: The continuing evolution of medical treatments and the loss of neutrality of medicine with respect to morality of human values have represented the major tracking elements towards settings of sharing of choices between society and medicine. Several concerns have been raised upon links between pharmaceutical corporations and researchers. Moreover, being in a learning environment, we must pay even more attention to these items because students appear to be at risk for unrecognized influence by marketing efforts. The aim of this study is to focus on the activities of a local ethics committee (LEC and the characteristics of the protocols discussed in an Italian LEC during a three year period (2001-2003.

    Methods: Three years of activity of a LEC were analysed by a questionnaire registering: main sponsorship, setting, technical characteristics of trials, outcome of the submission to the LEC, state of progress. Approved trials were followed-up until April 30th, 2005.

    Results: A total of 345 protocols were discussed. 67.8% (n = 198 of approved protocols were submitted by a pharmaceutical corporation. 72.6% (n = 212 of studies approved in 2001 were still in progress in 2005. 91.3% (n = 73 of closed trials had a pharmaceutical corporation as their main sponsor. None of the submitted studies focused on prevention strategies.

    Conclusions: These results show how important grants offered by pharmaceutical industries are, the efforts spent on therapy and the lack of investors in prevention.

  5. An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

    Directory of Open Access Journals (Sweden)

    Sharmila V Jalgaonkar

    Full Text Available Protocol deviations (PDs may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47. Maximum study procedure related PDs were due to patient visiting outside window period (126/304. Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447. The most common corrective actions stated by PI were participant counseling (85/323 and caution in future (70/323. The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

  6. An Audit of Protocol Deviations Submitted to an Institutional Ethics Committee of a Tertiary Care Hospital.

    Science.gov (United States)

    Jalgaonkar, Sharmila V; Bhide, Shruti S; Tripathi, Raakhi K; Shetty, Yashashri C; Marathe, Padmaja A; Katkar, Janhavi; Thatte, Urmila M

    2016-01-01

    Protocol deviations (PDs) may jeopardize safety, rights, and welfare of subjects and data integrity. There is scarce literature and no guidelines for Institutional Ethics Committees (IECs) to process PD reports. The PD reports submitted to IECs from Jan 2011 to August 2014 were analyzed retrospectively. Types of studies reporting PDs, category and type of PDs, PD rate per participant, time of reporting PD since its occurrence and corrective actions stated by principal investigator (PI) for major deviations were noted. Out of 447 PDs from 73/1387 total studies received during study period, 402 were from 126 pharma studies. Investigator initiated studies and dissertations reported negligible PDs. Median number of PDs was 4 per protocol. Out of 447 PDs, 304 were related to study procedure, 87, 47 and 9 were from safety, informed consent document (ICD) and eligibility category respectively. The most common reason for PDs was incomplete ICD (22/47). Maximum study procedure related PDs were due to patient visiting outside window period (126/304). Thirty five of 87 PDs were due to missed safety assessment. The overall PD reporting rate per participant was 0.08. In 90% of reports, date of occurrence of PD was not specified. The median delay for reporting PDs after occurrence was 94 days. PDs classified as Major were 73% (323/447). The most common corrective actions stated by PI were participant counseling (85/323) and caution in future (70/323). The study findings emphasize the need for GCP training at regular interval of study team members. IEC have to be vigilant and visit sites frequently, take initiative and formulate guidelines regarding PD reporting.

  7. Sample size determinations in original research protocols for randomised clinical trials submitted to UK research ethics committees: review.

    Science.gov (United States)

    Clark, Timothy; Berger, Ursula; Mansmann, Ulrich

    2013-03-21

    To assess the completeness of reporting of sample size determinations in unpublished research protocols and to develop guidance for research ethics committees and for statisticians advising these committees. Review of original research protocols. Unpublished research protocols for phase IIb, III, and IV randomised clinical trials of investigational medicinal products submitted to research ethics committees in the United Kingdom during 1 January to 31 December 2009. Completeness of reporting of the sample size determination, including the justification of design assumptions, and disagreement between reported and recalculated sample size. 446 study protocols were reviewed. Of these, 190 (43%) justified the treatment effect and 213 (48%) justified the population variability or survival experience. Only 55 (12%) discussed the clinical importance of the treatment effect sought. Few protocols provided a reasoned explanation as to why the design assumptions were plausible for the planned study. Sensitivity analyses investigating how the sample size changed under different design assumptions were lacking; six (1%) protocols included a re-estimation of the sample size in the study design. Overall, 188 (42%) protocols reported all of the information to accurately recalculate the sample size; the assumed withdrawal or dropout rate was not given in 177 (40%) studies. Only 134 of the 446 (30%) sample size calculations could be accurately reproduced. Study size tended to be over-estimated rather than under-estimated. Studies with non-commercial sponsors justified the design assumptions used in the calculation more often than studies with commercial sponsors but less often reported all the components needed to reproduce the sample size calculation. Sample sizes for studies with non-commercial sponsors were less often reproduced. Most research protocols did not contain sufficient information to allow the sample size to be reproduced or the plausibility of the design assumptions to

  8. Do Chinese Researchers Conduct Ethical Research and Use Ethics Committee Review in Clinical Trials of Anti-Dementia Drugs? An Analysis of Biomedical Publications Originating from China.

    Science.gov (United States)

    Zeng, Lingfeng; Liang, Weixiong; Pan, Jianke; Cao, Ye; Liu, Jun; Wang, Qi; Wang, Lu; Zou, Yuanping; Wang, Kezhu; Kong, Lingshuo; Xie, Hui; Xu, Weihua; Li, Weirong; Zhao, Wei; Mi, Suiqing; Chen, Yunbo; Cheng, Shuyi; Li, Xiaoyan; Cao, Qian; Zeng, Xing; Wang, Ningsheng

    2016-03-25

    Medical research using human participants must conform to the basic ethical principles found in the Declaration of Helsinki (DoH) of the World Medical Association. The purpose of this review was to assess whether journals in China have improved in regard to the fulfillment of ethical disclosure procedures for clinical trials of anti-dementia drugs. Four medical databases were searched for articles reporting clinical trials of oral anti-dementia drugs published in China in 2003, 2009, and 2014. The frequencies of reporting of informed consent from participants (ICP), approval of a regional ethical committee (REC), reference to DoH, and study registration were estimated respectively. Statistical analyses were conducted with SPSS v21 software. Among those randomized controlled trials published in 2003, 2009, and 2014, disclosure of REC approval was present for 2.67%, 1.15%, and 6.84%; statements of ICP were included in 9.33%, 7.76%, and 17.34%; reference to DoH was found for 4.00%, 1.44%, and 7.45%; and study registration reporting was included in 2.67%, 2.59%, and 9.28%, respectively. Improvements to reporting rates between 2009 and 2014 were seen, with more than twice as many trials reporting REC approval, ICP, reference to DoH, and study registration compared with 2009. Compared with 2003 and 2009, reporting rates for REC approval, ICP, reference to DoH, and study registration for clinical trials of anti-dementia drugs were enhanced in 2014 in the major medical journals of China. However, biomedical publications without definite statements of ethical considerations remain common, and this continues to be seen in Chinese journals. It is imperative that measures are taken to reinforce the ethical protection in clinical trials in China.

  9. Mapping African ethical review committee activity onto capacity needs: the MARC initiative and HRWeb's interactive database of RECs in Africa.

    Science.gov (United States)

    IJsselmuiden, Carel; Marais, Debbie; Wassenaar, Douglas; Mokgatla-Moipolai, Boitumelo

    2012-08-01

    Health research initiatives worldwide are growing in scope and complexity, particularly as they move into the developing world. Expanding health research activity in low- and middle-income countries has resulted in a commensurate rise in the need for sound ethical review structures and functions in the form of Research Ethics Committees (RECs). Yet these seem to be lagging behind as a result of the enormous challenges facing these countries, including poor resource availability and lack of capacity. There is thus an urgent need for ongoing capacity and resource development in these regions in general, and in Africa in particular. Similarly, there is a need for research and initiatives that can identify existing capacity and funding and indicate the areas where this needs to be developed. This discussion paper argues that the Mapping African Research Ethics Capacity (MARC) project is a timely initiative aimed at identifying existing capacity. MARC provides a platform and tool on the Council on Health Research for Development's (COHRED) Health Research website (HRWeb), which can be used by RECs and key stakeholders in health research in Africa to identify capacity, constraints and development needs. MARC intends to provide the first comprehensive interactive database of RECs in Africa, which will allow for the identification of key relationships and analyses of capacity. The potential of MARC lies in the mapping of current ethical review activity onto capacity needs. This paper serves as a starting point by providing a descriptive illustration of the current state of RECs in Africa. © 2012 Blackwell Publishing Ltd.

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

    Science.gov (United States)

    Segarra, Ignacio; Modamio, Pilar; Fernández, Cecilia; Mariño, Eduardo L

    2017-01-01

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

  11. Views of the process and content of ethical reviews of HIV vaccine trials among members of US institutional review boards and South African research ethics committees.

    Science.gov (United States)

    Klitzman, Robert

    2008-12-01

    Given the ethical controversies concerning HIV vaccine trials (HVTs), we aimed to understand through an exploratory study how members of institutional review boards (IRBs) in the United States (US) and research ethics committees (RECs) in South Africa (SA) view issues concerning the process and content of reviews of these studies. We mailed packets of 20 questionnaires to 12 US IRB chairs and administrators and seven REC chairs to distribute to their members. We received 113 questionnaires (76 from the US and 37 from SA). In both countries, members tended to be white males with advanced academic degrees. Compared to the US, SA members called for 'major changes' in HVT protocols more frequently (p = 0.004), and were less likely to think that HVT participants understood risks and benefits (p = 0.033) or informed consent forms (p = 0.000). In both countries, members were divided on several critical issues (e.g. the minimum standard for treatment for HVT participants who became infected during the HVT), but agreed that they needed more training. Of the SA respondents, 40% reported that they were 'self-taught' in ethics. This study, the first we know of to offer quantitative data comparing US vs. non-US IRBs/RECs, thus suggests key similarities and differences (e.g. compared to SA respondents, US respondents appeared to overestimate participants' understanding of informed consent), along with needs for education. These initial exploratory data in this area have important implications for IRBs, RECs, policy-makers and scholars concerning future practice, training, policy, and investigations in research ethics, and prevention and treatment of HIV and other diseases in the developing world and elsewhere.

  12. Biomedical Research Ethics Committees in sub-Saharan Africa: a collective review of their structure, functioning, and outcomes.

    Science.gov (United States)

    Silaigwana, Blessing; Wassenaar, Douglas

    2015-04-01

    Research Ethics Committees (RECs) are mandated to protect human participants by conducting ethical reviews of biomedical research. To date, there is a dearth of information on the structure, functioning, and outcomes of RECs in Africa. This article reviews empirical studies investigating African RECs, with the aim of providing an overview of what is known and identifying gaps in our knowledge. We conducted a literature search of the EBSCO, PubMed, and Google Scholar electronic databases. Twenty-three empirical studies reporting on the structure, functions, and outcomes of African RECs were included in our analysis. The review yielded limited systematic data on RECs in Africa. Available empirical evidence suggests that challenges hampering the effective functioning of RECs included lack of membership diversity, scarcity of resources, insufficient training of members, inadequate capacity to review and monitor studies, and lack of national ethics guidelines and accreditation. Relatively little data on the review outcomes of African RECs were described. There is an ongoing need for concerted efforts from various stakeholders to support capacity development and enhancement of African RECs. © The Author(s) 2015.

  13. Ethical issues in research involving minority populations: the process and outcomes of protocol review by the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, Thailand.

    Science.gov (United States)

    Adams, Pornpimon; Wongwit, Waranya; Pengsaa, Krisana; Khusmith, Srisin; Fungladda, Wijitr; Chaiyaphan, Warissara; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Kaewkungwal, Jaranit

    2013-09-11

    Recruiting minorities into research studies requires special attention, particularly when studies involve "extra-vulnerable" participants with multiple vulnerabilities, e.g., pregnant women, the fetuses/neonates of ethnic minorities, children in refugee camps, or cross-border migrants. This study retrospectively analyzed submissions to the Ethics Committee of the Faculty of Tropical Medicine (FTM-EC) in Thailand. Issues related to the process and outcomes of proposal review, and the main issues for which clarification/revision were requested on studies, are discussed extensively. The study data were extracted from proposals and amendments submitted to the FTM-EC during the period October 2009 - September 2012, and then analyzed qualitatively and quantitatively. The main issues for clarification/revision were analyzed by thematic content analysis. 373 proposals were submitted; 44 studies involved minority groups with 21 extra-vulnerable minorities. All clinical and 2/3 of non-clinical studies submitted for initial review underwent full-board review. For combined clinical and non-clinical study submissions, 92.1% were referred back to the investigators and approved after clarification/revision, while 2.7% were deferred due to major/critical changes, and 2.1% not approved due to substantial violations of ethical principles. The main issues needing clarification/revision differed between all studies and those involving minorities: participant information sheet (62.2% vs. 86.4%), informed consent/assent form (51.2% vs. 86.4%), and research methodology (80.7% vs. 84.1%), respectively. The main ethical issues arising during the meetings, regarding studies involving minorities, included ensuring no exploitation, coercion, or pressure on the minority to participate; methodology not affecting their legal status; considering ethnicity and cultural structure; and providing appropriate compensation. Delays in the approval or non-approval of studies involving minorities were

  14. Can I trust them to do everything? The role of distrust in ethics committee consultations for conflict over life-sustaining treatment among Afro-Caribbean patients.

    Science.gov (United States)

    Romain, Frederic; Courtwright, Andrew

    2016-09-01

    Distrust in the American healthcare system is common among Afro-Caribbeans but the role of this distrust in conflict over life-sustaining treatment is not well described. To identify the ways that distrust manifests in ethics committee consultation for conflict over life-sustaining treatment among Afro-Caribbean patients. This was a retrospective cohort study at a large academic hospital of all ethics committee consultations for life-sustaining treatment among Afro-Caribbean patients and their surrogates. We reviewed medical records and identified cases in which ethics consultants described distrust as playing a role in the conflict over life-sustaining treatment. Of the 169 ethics committee consultation cases for conflict over life-sustaining treatment, 11 (6.5%) involved patients who self-identified as Afro-Caribbean. Distrust played a role in several of these cases, with surrogates of three patients, in particular, illustrating the way that perceived heath disparities, past labelling and concerns about continued maltreatment generated distrust leading to conflict over life-sustaining treatment. Exploring issues of distrust may help ethics consultants identify the source of conflict over life-sustaining treatment among Afro-Caribbean patients. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  15. Non-commercial vs. commercial clinical trials: a retrospective study of the applications submitted to a research ethics committee.

    Science.gov (United States)

    Fuentes Camps, Inmaculada; Rodríguez, Alexis; Agustí, Antonia

    2018-02-15

    There are many difficulties in undertaking independent clinical research without support from the pharmaceutical industry. In this retrospective observational study, some design characteristics, the clinical trial public register and the publication rate of noncommercial clinical trials were compared to those of commercial clinical trials. A total of 809 applications of drug-evaluation clinical trials were submitted from May 2004 to May 2009 to the research ethics committee of a tertiary hospital, and 16.3% of trials were noncommercial. They were mainly phase IV, multicentre national, and unmasked controlled trials, compared to the commercial trials that were mainly phase II or III, multicentre international, and double-blind masked trials. The commercial trials were registered and published more often than noncommercial trials. More funding for noncommercial research is still needed. The results of the research, commercial or noncommercial, should be disseminated in order not to compromise either its scientific or its social value. © 2018 The British Pharmacological Society.

  16. Ethics committees in Catholic hospitals. A new study assesses their role, impact, and future in CHA-member hospitals.

    Science.gov (United States)

    Bernt, Francis; Clark, Peter; Starrs, Josita; Talone, Patricia

    2006-01-01

    The role, effectiveness, and even existence of hospital ethics committees (HECs) are not universally agreed upon. Over the past 20 years, the study of HECs has focused mainly on their structure, scope, and function, making the results more descriptive than anything. In an effort to present study results that could help HECs better serve the needs of their organizations, the authors of this article recently set out to survey HEC chairs at CHA-member hospitals, asking questions about four key areas: 1) primary functions of an HEC, 2) selection criteria of HEC members, 3) strategies for success, and 4) the importance of HEC member training. The results of this survey provide some important food for thought.

  17. Dialysis Withdrawal: Impact and Evaluation of a Multidisciplinary Deliberation Within an Ethics Committee as a Shared-Decision-Making Model.

    Science.gov (United States)

    Maurizi Balzan, Jocelyne; Cartier, Jean Charles; Calvino-Gunther, Silvia; Carron, Pierre Louis; Baro, Patrice; Palacin, Pedro; Vialtel, Paul

    2015-08-01

    Since dialysis withdrawal in maintenance dialysis patients with limited life expectancy results always in short-term death, nephrologists need a referenced process to make their decision. This study reviews 8 years of operation of an Ethics Committee in Nephrology (ECN). The ECN, within a multidisciplinary team, once a month explores cases reported by caregivers when maintaining dialysis seems not to be in the patient's best interest. Discussion is required when the vital prognosis is engaged by the evolution of the chronic kidney disease (CKD) or the occurrence of an acute medical event. Data are analyzed using a discussion guide. The informed decision is completed with an appropriated palliative care project involving the patient, and recorded in their file. Since 2006, the ECN has deliberated yearly for 10 sessions on 6-18 cases, concerning 380 identified maintenance dialysis patients. Characteristics of the population, cases, sessions and proposals are recorded and analyzed. The only variable associated with dialysis withdrawal was having at least one new comorbid condition. End of life is supported with the help of the palliative care team in the hospital or exceptionally at home. The ECN, through a multidisciplinary deliberation and resolution process, proposes an ethical shared-decision-making model ensuring that dialysis withdrawal follows professional guidelines, and is registered as a method for evaluating professional practice (EPP). Annual activity reports are submitted to the Hospital's Medical Evaluation and Quality Unit. Benefits are individual and collective for patients, relatives and caregivers. Prospects for reducing non-implemented decisions and identifying cases earlier would improve the Committee effectiveness. © 2015 The Authors. Therapeutic Apheresis and Dialysis © 2015 International Society for Apheresis.

  18. Access to fertility services by transgender persons: an Ethics Committee opinion.

    Science.gov (United States)

    2015-11-01

    This statement explores the ethical considerations surrounding the provision of fertility services to transgender individuals and concludes that denial of access to fertility services is not justified. Copyright © 2015 American Society for Reproductive Medicine. Published by Elsevier Inc. All rights reserved.

  19. Is your ethics committee efficient? Using "IRB Metrics" as a self-assessment tool for continuous improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand.

    Science.gov (United States)

    Adams, Pornpimon; Kaewkungwal, Jaranit; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Pengsaa, Krisana; Khusmith, Srisin

    2014-01-01

    Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an "IRB Metrics" was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010-September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with

  20. Is Your Ethics Committee Efficient? Using “IRB Metrics” as a Self-Assessment Tool for Continuous Improvement at the Faculty of Tropical Medicine, Mahidol University, Thailand

    Science.gov (United States)

    Adams, Pornpimon; Kaewkungwal, Jaranit; Limphattharacharoen, Chanthima; Prakobtham, Sukanya; Pengsaa, Krisana; Khusmith, Srisin

    2014-01-01

    Tensions between researchers and ethics committees have been reported in several institutions. Some reports suggest researchers lack confidence in the quality of institutional review board (IRB) reviews, and that emphasis on strict procedural compliance and ethical issues raised by the IRB might unintentionally lead to delays in correspondence between researchers and ethics committees, and/or even encourage prevarication/equivocation, if researchers perceive committee concerns and criticisms unjust. This study systematically analyzed the efficiency of different IRB functions, and the relationship between efficiency and perceived quality of the decision-making process. The major purposes of this study were thus (1) to use the IRB Metrics developed by the Faculty of Tropical Medicine, Mahidol University, Thailand (FTM-EC) to assess the operational efficiency and perceived effectiveness of its ethics committees, and (2) to determine ethical issues that may cause the duration of approval process to be above the target limit of 60 days. Based on a literature review of definitions and methods used and proposed for use, in assessing aspects of IRB quality, an “IRB Metrics” was developed to assess IRB processes using a structure-process-outcome measurement model. To observe trends in the indicators evaluated, data related to all protocols submitted to the two panels of the FTM-EC (clinical and non-clinical), between January 2010–September 2013, were extracted and analyzed. Quantitative information based on IRB Metrics structure-process-outcome illuminates different areas for internal-process improvement. Ethical issues raised with researchers by the IRB, which were associated with the duration of the approval process in protocol review, could be considered root causes of tensions between the parties. The assessment of IRB structure-process-outcome thus provides a valuable opportunity to strengthen relationships and reduce conflicts between IRBs and researchers, with

  1. Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review.

    Science.gov (United States)

    van Lent, Marlies; Rongen, Gerard A; Out, Henk J

    2014-12-10

    Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials. Retrospective analysis of 226 protocols of drug trials approved in 2010-2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature. Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95). RECs identified important ethical and

  2. An evaluation of knowledge, attitude, and practice of institutional ethics committee members from eastern India regarding ethics committee functioning and pharmacovigilance activities conducted during clinical trials: A pilot study.

    Science.gov (United States)

    Bhowmick, Subhrojyoti; Banerjee, Koyel; Sikdar, Shreya; Chatterjee, Tapan Kumar

    2014-07-01

    The vital responsibility of Institutional Ethics Committee (IEC) members is to ensure the safety of the subjects participating in clinical trials. Hence, it is essential for IEC members to be aware of the common pharmacovigilance strategies followed during clinical trials. However, the information about the knowledge, attitude, and practice of IEC members regarding the pharmacovigilance activities followed during clinical trials is scarce worldwide, especially in India. Hence, this cross-sectional study was designed to assess the knowledge, attitude, and practice of IEC members of 10 hospitals of Kolkata, India. A cross-sectional study using a self-administered, validated questionnaire was conducted among 10 hospitals (five government and five corporate hospitals) in Kolkata conducting active clinical research and having functional Ethics Committees (ECs) in the month of September-November, 2012. An IEC approval was taken for this study. Two reminders were given to all EC members through telephone/e-mail for completion and returning of the forms. The filled in forms were returned to their respective Member Secretaries, from whom authors' collected the forms. Data were analyzed using SPSS version 16.0 software and MS-Excel 2007. Categorical data were analyzed using Chi-square test and a P < 0.05 was considered statistically significant. Out of the 100 distributed questionnaires, 40 were returned of which 10 were not filled properly. Overall awareness regarding different pharmacovigilance terminologies and activities among EC members from nonmedical background (71.43%) was found to be more than that of the medical members (68.75%), though the figure was not statistically significant. Majority of the members (75%) felt that EC should decide compensation in case of a serious adverse event. The present study signifies that there is a low level of awareness in IEC members of Kolkata regarding pharmacovigilance activities conducted during clinical trials; and, hence the

  3. ACOG Committee Opinion No. 510: Ethical ways for physicians to market a practice.

    Science.gov (United States)

    2011-11-01

    It is ethical for physicians to market their practices provided that the communication is truthful and not misleading, deceptive, or discriminatory. All paid advertising must be clearly identified as such. Producing fair and accurate advertising of medical practices and services can be challenging. It often is difficult to include detailed information because of cost and size restrictions or the limitations of the media form that has been selected. If the specific advertising form does not lend itself to clear and accurate description, an alternative media format should be selected. Advertising that seeks to denigrate the competence of other individual professionals or group practices is always unethical.

  4. Committees

    Science.gov (United States)

    2012-11-01

    Leadership Team of the IAHR Committee for Hydraulic Machinery and Systems Eduard EGUSQUIZA, UPC Barcelona, Spain, Chair François AVELLAN, EPFL-LMH, Switzerland, Past Chair Richard K FISHER, Voith Hydro Inc., USA, Past Chair Fidel ARZOLA, Edelca, Venezuela Michel COUSTON, Alstom Hydro, France Niklas DAHLBÄCKCK, Vatenfall, Sweden Normand DESY, Andritz VA TECH Hydro Ltd., Canada Chisachi KATO, University of Tokyo, Japan Andrei LIPEJ, Turboinstitut, Slovenija Torbjørn NIELSEN, NTNU, Norway Romeo SUSAN-RESIGA, 'Politehnica' University Timisoara, Romania Stefan RIEDELBAUCH, Stuggart University, Germany Albert RUPRECHT, Stuttgart University, Germany Qing-Hua SHI, Dong Fang Electrical Machinery Co., China Geraldo TIAGO, Universidade Federal de Itajubá, Brazil International Advisory Committee Shouqi YUAN (principal) Jiangsu University China QingHua SHI (principal) Dong Fang Electrical Machinery Co. China Fidel ARZOLA EDELCA Venezuela Thomas ASCHENBRENNER Voith Hydro GmbH & Co. KG Germany Anton BERGANT Litostroj Power doo Slovenia B C BHAOYAL Research & Technology Centre India Hermod BREKKE NTNU Norway Stuart COULSON Voith Hydro Inc. USA Paul COOPER Fluid Machinery Research Inc USA V A DEMIANOV Power Machines OJSC Russia Bart van ESCH Technische Universiteit Eindhoven Netherland Arno GEHRER Andritz Hydro Graz Austria Akira GOTO Ebara Corporation Japan Adiel GUINZBURG The Boeing Company USA D-H HELLMANN KSB AG Germany Ashvin HOSANGADI Combustion Research and Flow Technology USA Byung-Sun HWANG Korea Institute of Material Science Korea Toshiaki KANEMOTO Kyushu Institute of Technology Japan Mann-Eung KIM Korean Register of Shipping Korea Jiri KOUTNIK Voith Hydro GmbH & Co. KG Germany Jinkook LEE Eaton Corporation USA Young-Ho LEE Korea Maritime University Korea Woo-Seop LIM Hyosung Goodsprings Inc Korea Jun MATSUI Yokohama National University Japan Kazuyoshi Mitsubishi H I Ltd, Japan MIYAGAWA Christophe NICOLET Power Vision Engineering Srl Switzerland Maryse PAGE Hydro

  5. Research ethics committees in the regulation of clinical research: comparison of Finland to England, Canada, and the United States.

    Science.gov (United States)

    Hemminki, Elina

    2016-01-19

    The aim of this paper is to compare common features and variation in the work of research ethics committees (RECs) in Finland to three other countries - England, Canada, the United States of America (USA) - in the late 2000s. Several approaches and data sources were used, including semi- or unstructured interviews of experts, documents, previous reports, presentations in meetings and observations. A theoretical framework was created and data from various sources synthesized. In Finland, RECs were regulated by a medical research law, whereas in the other countries many related laws and rules guided RECs; drug trials had specific additional rules. In England and the USA, there was a REC control body. In all countries, members were voluntary and included lay-persons, and payment arrangements varied. Patient protection was the main ethics criteria, but other criteria (research advancement, availability of results, payments, detailed fulfilment of legislation) varied. In all countries, RECs had been given administrative duties. Variations by country included the mandate, practical arrangements, handling of multi-site research, explicitness of proportionate handlings, judging scientific quality, time-limits for decisions, following of projects, role in institute protection, handling conflicts of interests, handling of projects without informed consent, and quality assurance research. The division of work between REC members and secretariats varied in checking of formalities. In England, quality assurance of REC work was thorough, fairly thorough in the USA, and not performed in Finland. The work of RECs in the four countries varied notably. Various deficiencies in the system require action, for which international comparison can provide useful insights.

  6. Gender equality in the work of local research ethics committees in Europe: a study of practice in five countries

    Science.gov (United States)

    Moerman, C J; Haafkens, J A; Söderström, M; Rásky, É; Maguire, P; Maschewsky‐Schneider, U; Norstedt, M; Hahn, D; Reinerth, H; McKevitt, N

    2007-01-01

    Background Funding organisations and research ethics committees (RECs) should play a part in strengthening attention to gender equality in clinical research. In the research policy of European Union (EU), funding measures have been taken to realise this, but such measures are lacking in the EU policy regarding RECs. Objective To explore how RECs in Austria, Germany, Ireland, The Netherlands and Sweden deal with gender equality issues by asking two questions: (1) Do existing procedures promote representation of women and gender expertise in the committee? (2) How are sex and gender issues dealt with in protocol evaluation? Methods Two RECs were selected from each country. Data were obtained through interviews with key informants and content analysis of relevant documents (regulations, guidelines and review tools in use in 2003). Results All countries have rules (mostly informal) to ensure the presence of women on RECs; gender expertise is not required. Drug study protocols are carefully evaluated, sometimes on a formal basis, as regards the inclusion of women of childbearing age. The reason for excluding either one of the sexes or including specific groups of women or making a gender‐specific risk–benefit analysis are investigated by some RECs. Such measures are, however, neither defined in the regulations nor integrated in review tools. Conclusions The RECs investigated in five European member states are found to pay limited attention to gender equality in their working methods and, in particular in protocol evaluation. Policy and regulations of EU are needed to strengthen attention to gender equality in the work of RECs. PMID:17264199

  7. Ethics.

    Science.gov (United States)

    Pellegrino, Edmund D

    In this brief annual review of ethical issues in medicine, Pellegrino focuses on two issues, AIDS and surrogate mothers. The AIDS epidemic has generated debate over public health needs vs. individual rights, modification of sexual practices, screening programs to detect infected persons, confidentiality of test results, experimental therapies, and the duty of physicians to care for AIDS patients. Surrogate motherhood arrangements have become one of the more controversial of the new reproductive technologies. The publicity that accompanied the custody battle over New Jersey's "Baby M" intensified debate over the commercialization of childbearing and the regulation of reproduction. Pellegrino concludes that physicians, along with ethicists and policymakers, have an obligation to "lead society in careful and judicious deliberation" of the ethical issues raised by AIDS and by reproductive technologies.

  8. EsPRit: ethics committee proposals for Long Term Medical Data Registries in rapidly evolving research fields - a future-proof best practice approach.

    Science.gov (United States)

    Oberbichler, S; Hackl, W O; Hörbst, A

    2017-10-18

    Long-term data collection is a challenging task in the domain of medical research. Many effects in medicine require long periods of time to become traceable e.g. the development of secondary malignancies based on a given radiotherapeutic treatment of the primary disease. Nevertheless, long-term studies often suffer from an initial lack of available information, thus disallowing a standardized approach for their approval by the ethics committee. This is due to several factors, such as the lack of existing case report forms or an explorative research approach in which data elements may change over time. In connection with current medical research and the ongoing digitalization in medicine, Long Term Medical Data Registries (MDR-LT) have become an important means of collecting and analyzing study data. As with any clinical study, ethical aspects must be taken into account when setting up such registries. This work addresses the problem of creating a valid, high-quality ethics committee proposal for medical registries by suggesting groups of tasks (building blocks), information sources and appropriate methods for collecting and analyzing the information, as well as a process model to compile an ethics committee proposal (EsPRit). To derive the building blocks and associated methods software and requirements engineering approaches were utilized. Furthermore, a process-oriented approach was chosen, as information required in the creating process of ethics committee proposals remain unknown in the beginning of planning an MDR-LT. Here, we derived the needed steps from medical product certification. This was done as the medical product certification itself also communicates a process-oriented approach rather than merely focusing on content. A proposal was created for validation and inspection of applicability by using the proposed building blocks. The proposed best practice was tested and refined within SEMPER (Secondary Malignoma - Prospective Evaluation of the

  9. ACOG Committee Opinion No. 341. Ethical ways for physicians to market a practice.

    Science.gov (United States)

    2006-07-01

    It is ethical for physicians to market their practices through any form of public communication provided that the communication is truthful and not misleading or deceptive. Communications should not convey discriminatory attitudes involving race, ethnicity, gender; or sexual orientation.All paid advertising must be clearly identified as such. Producing fair and accurate advertising of medical practices and services can be challenging. It often is difficult to include detailed information because of cost and size restrictions or the limitations of the media form that has been selected. If the specific advertising form does not lend itself to clear and accurate description, an alternative media format should be selected. Finally, any advertising that seeks to denigrate the competence of other individual professionals or group practices is always considered unethical.

  10. E-survey with researchers, members of ethics committees and sponsors of clinical research in Brazil: an emerging methodology for scientific research.

    Science.gov (United States)

    Dainesi, Sonia Mansoldo; Goldbaum, Moisés

    2012-12-01

    The growth of Internet users enables epidemiological studies to be conducted electronically, representing a promising methodology for data collection. Members of Ethics Committees, Clinical Researchers and Sponsors were interviewed using questionnaires sent over the Internet. Along with the questionnaire, participants received a message explaining the survey and also the informed consent. Returning the questionnaire meant the consent of the participant was given. No incentive was offered; two reminders were sent. The response rate was 21% (124/599), 20% (58/290) and 45% (24/53) respectively for Ethics Committees, Researchers and Sponsors. The percentage of return before the two reminders was about 62%. Reasons for non-response: participant not found, refusal to participate, lack of experience in clinical research or in the therapeutic field. Characteristics of participants: 45% of Ethics Committee participants, 64% of Researchers and 63% of Sponsors were male; mean age (range), respectively: 47 (28-74), 53 (24-72) and 40 (29-65) years. Among Researchers and Sponsors, all respondents had at least a university degree and, in the Ethics Committees group, only two (1.7%) did not have one. Most of the questionnaires in all groups came from the Southeast Region of Brazil, probably reflecting the highest number of clinical trials and research professionals in this region. Despite the potential limitations of a survey done through the Internet, this study led to a response rate similar to what has been observed with other models, efficiency in obtaining responses (speed and quality), convenience for respondents and low cost.

  11. Locating Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2013-01-01

    , assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, and development anthropology. Drawing on material from ethnographic fieldwork with the NGO in Sri Lanka, Thailand, the Philippines, Taiwan and mainland China over 12 months between March 2009 and November 2010, it advances an argument that the uptake of ethics through forms such as the Ethics Review Committee...

  12. Polish Industry and Art at CERN

    CERN Multimedia

    2000-01-01

    On 17 October 2000 the second Polish industrial and technological exhibition opened at CERN. The first one was held five years ago and nine of the companies that were present then have come back again this year. Six of those companies were awarded contracts with CERN in 1995. Three Polish officials were present at the Opening Ceremony today: Mrs Malgorzata Kozlowska, Under-secretary of State in the State Committee for Scientific Research, Mr Henryk Ogryczak, Under-secretary of State in Ministry of Economy and Prof. Jerzy Niewodniczanski, President of National Atomic Energy Agency. Professor Luciano Maiani welcomed the Polish delegation to CERN and stressed the important contribution of Polish scientists and industrialists to the work of the laboratory. Director General Luciano Maiani (back left) and head of SPL division Karl-Heinz Kissler (back right) visit the Poland at CERN exhibition… The exhibition offers Polish companies the opportunity to establish professional contacts with CERN. Nineteen companies...

  13. The risk-benefit task of research ethics committees: An evaluation of current approaches and the need to incorporate decision studies methods

    Directory of Open Access Journals (Sweden)

    Bernabe Rosemarie D L C

    2012-04-01

    Full Text Available Abstract Background Research ethics committees (RECs are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. Discussion By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs’ risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision. Conclusion As such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs’ risk-benefit task.

  14. The risk-benefit task of research ethics committees: an evaluation of current approaches and the need to incorporate decision studies methods.

    Science.gov (United States)

    Bernabe, Rosemarie D L C; van Thiel, Ghislaine J M W; Raaijmakers, Jan A M; van Delden, Johannes J M

    2012-04-20

    Research ethics committees (RECs) are tasked to assess the risks and the benefits of a trial. Currently, two procedure-level approaches are predominant, the Net Risk Test and the Component Analysis. By looking at decision studies, we see that both procedure-level approaches conflate the various risk-benefit tasks, i.e., risk-benefit assessment, risk-benefit evaluation, risk treatment, and decision making. This conflation makes the RECs' risk-benefit task confusing, if not impossible. We further realize that RECs are not meant to do all the risk-benefit tasks; instead, RECs are meant to evaluate risks and benefits, appraise risk treatment suggestions, and make the final decision. As such, research ethics would benefit from looking beyond the procedure-level approaches and allowing disciplines like decision studies to be involved in the discourse on RECs' risk-benefit task.

  15. The evaluation of complex clinical trial protocols: resources available to research ethics committees and the use of clinical trial registries--a case study.

    Science.gov (United States)

    Homedes, Núria; Ugalde, Antonio

    2015-06-01

    To assess the potential role of clinical trial (CT) registries and other resources available to research ethics committees (RECs) in the evaluation of complex CT protocols in low-income and middle-income countries. Using a case study approach, the authors examined the decision-making process of a REC in Argentina and its efforts to use available resources to decide on a complex protocol. We also analysed the information in the USA and other CT registries and consulted 24 CT experts in seven countries. Information requested by the Argentinean REC from other national RECs and ethics' experts was not useful to verify the adequacy of the REC's decision whether or not to approve the CT. The responses from the national regulatory agency and the sponsor were not helpful either. The identification of international resources that could assist was beyond the REC's capability. The information in the USA and other CT registries is limited, and at times misleading; and its accuracy is not verified by register keepers. RECs have limited access to experts and institutions that could assist them in their deliberations. Sponsors do not always answer RECs' request for information to properly conduct the ethical and methodological assessment of CT protocols. The usefulness of the CT registries is curtailed by the lack of appropriate codes and by data errors. Information about reasons for rejection, withdrawal or suspension of the trial should be included in the registries. Establishing formal channels of communication among national and foreign RECs and with independent international reference centres could strengthen the ethical review of CT protocols. 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. Metal polish poisoning

    Science.gov (United States)

    Metal polishes are used to clean metals, including brass, copper, or silver. This article discusses the harmful effects from swallowing metal polish. This article is for information only. DO NOT use ...

  17. Williamson Polishing & Plating Site

    Science.gov (United States)

    Williamson Polishing & Plating Co. Inc. was a plating shop located in the Martindale-Brightwood neighborhood of Indianapolis. The facility conducted job shop polishing and electroplating services. The vacant site contains a 14,651-square-foot building.

  18. Locating Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2013-01-01

    Research ethics has become integrated into what it means to conduct good science. This thesis is about the nature of that integration, which I argue is not neutral, carrying with it ideas of duty, moral obligations, organisational mechanisms, and processes of monitoring. For developing countries...... to participate in global research, the pre-requisite of ethical review has necessitated a growth in capacity building exercises. The chapters aim to elucidate ethnographically the activities and implications of 'capacity building' activities in biomedical research ethics, through following the trainings......, assessments and networking of the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a Non-Governmental Organisation. The work provides a critical reflection on the spread and uptake of ethics, contributing particularly to literatures in medical anthropology, organisational studies...

  19. [ETHICAL CONDUCT FOR RESEARCH INVOLVING INDIGENOUS PEOPLE IN FRANCE: A COMMENT OF THE CNRS ETHICS COMMITTEE OPINION ON THE IMPERATIVE OF FAIRNESS IN THE RELATIONSHIP BETWEEN RESEARCHERS AND INDIGENOUS PEOPLES].

    Science.gov (United States)

    Burelli, Thomas; Bambridge, Tamatoa

    2015-12-01

    Historically, scientific research and colonization process have maintained very close ties. In order to frame research involving indigenous peoples and to avoid situations of abuse, some States have developed very detailed ethicalframeworks. In France, there are no ethicalframework comparable to those observed in particular in Anglo-Saxon countries like Canada. Extensive discussions were conducted by the Ethics Committee of the CNRS leading to the adoption of an opinion of a high quality but which appears largely unknown and under-exploited. This opinion deals with "the delicate question of the rights of local and indigenous populations during the research projected conducted with their support in developed and developing countries (DCs)". In this paper, we propose to analyze how this opinion can be considered remarkable because it recognizes the current challenges of research projects involving indigenous people, but also because of his recommendations. We still see that the scope of its recommendations is however limited so far although some encouraging experiences like the recent adoption of the CRIOBE centre code of ethics in French Polynesia can be observed.

  20. 19th Polish Control Conference

    CERN Document Server

    Kacprzyk, Janusz; Oprzędkiewicz, Krzysztof; Skruch, Paweł

    2017-01-01

    This volume contains the proceedings of the KKA 2017 – the 19th Polish Control Conference, organized by the Department of Automatics and Biomedical Engineering, AGH University of Science and Technology in Kraków, Poland on June 18–21, 2017, under the auspices of the Committee on Automatic Control and Robotics of the Polish Academy of Sciences, and the Commission for Engineering Sciences of the Polish Academy of Arts and Sciences. Part 1 deals with general issues of modeling and control, notably flow modeling and control, sliding mode, predictive, dual, etc. control. In turn, Part 2 focuses on optimization, estimation and prediction for control. Part 3 is concerned with autonomous vehicles, while Part 4 addresses applications. Part 5 discusses computer methods in control, and Part 6 examines fractional order calculus in the modeling and control of dynamic systems. Part 7 focuses on modern robotics. Part 8 deals with modeling and identification, while Part 9 deals with problems related to security, fault ...

  1. The Battlefield Health and Trauma Research Institute Scientific Ethics Committee: An Evolving Model for Fostering a Culture of Integrity

    Science.gov (United States)

    2012-01-01

    grants and contracts.8 The ORI defines research misconduct as ‘‘fabrication, falsification, or plagiarism in proposing, performing, or reviewing research...fabrication, falsification, or plagiarism (FFP) is only 1% to 2%, based on self-reporting.10,11 However, approx- imately 33% of scientists admitted...provide investigators training and guidance? THE ACADEMIC MODEL Just as regulations governing the ethical use of human and animal research subjects grew

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

    Science.gov (United States)

    de Lecuona, Itziar

    2013-01-01

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

  3. The Ethics and Politics of Ethics Approval

    Science.gov (United States)

    Battin, Tim; Riley, Dan; Avery, Alan

    2014-01-01

    The regulatory scope of Human Research Ethics Committees can be problematic for a variety of reasons. Some scholars have argued the ethics approval process, for example, is antithetical to certain disciplines in the humanities and social sciences, while others are willing to give it qualified support. This article uses a case study to cast the…

  4. Under the shelter of ethics.

    Science.gov (United States)

    Lichterman, Boleslav L

    2005-01-01

    Problems of ethics committees in post-communist Russia are briefly discussed. The first ethics committees were established in 1980s upon the initiative of international pharmaceutical companies involved in clinical trials. Generally, such committees exist at hospitals conducting these trials and at research institutions dealing with human experimentation. They are bureaucratic structures heavily dependent on hospital or institution administration. Publication of research results in international periodicals is the main reason for their existence. An officially recognized National Ethics Committee is non-existent although there are several competing ethics committees at a national level (at the Ministry of Health, Academy of Sciences, Academy of Medical Sciences, Russian Medical association etc.). There is no federal legislation on the structure and status of ethics committees.

  5. Global Ethics Applied: Global Ethics, Economic Ethics

    OpenAIRE

    Stückelberger, Christoph

    2016-01-01

    Global Ethics Applied’ in four volumes is a reader of 88 selected articles from the author on 13 domains: Vol. 1 Global Ethics, Economic Ethics; Vol. 2 Environmental Ethics; Vol. 3 Development Ethics, Political Ethics, Dialogue and Peace Ethics, Innovation and Research Ethics, Information and Communication Ethics; Vol. 4 Bioethics and Medical Ethics, Family Ethics and Sexual Ethics, Leadership Ethics, Theological Ethics and Ecclesiology, Methods of Ethics. It concludes with the extended Bibli...

  6. Making Room for Ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2017-01-01

    This article examines the work that goes in to ‘making room’ for ethics, literally and figuratively. It follows the activities of a capacity building Asia-Pacific NGO in training and recognising ethics review committees, using multi-sited field materials collected over 12 months between 2009...... and 2010. Two queries drive this article: First, how are spaces made for ethical review –politically, infrastructurally, materially – as committee members campaign for attention to ethics and access to resources in which to conduct their meetings? Second, how are the limits of ‘local circumstance......’ negotiated during a review of the committee’s work: what does the implementation of standards in the area of ethics look like? I then discuss what standards of ethics practice mean for more fraught questions of the universal in bioethics. Rather than regarding ethics systems as backgrounds to global health...

  7. Polish Cartographical Review

    Directory of Open Access Journals (Sweden)

    Nedjeljko Frančula

    2017-07-01

    Full Text Available The Polish Cartographical Review (PCR journal has been published in English four times a year since 2015. The journal is in open access and it is published by De Gruyter Open. It is edited by Polish scientists in collaboration with international experts.

  8. Reporting of ethical committee approval and patient consent in the Portuguese Journal of Pulmonology and in the other Portuguese medical journals with impact factor

    Directory of Open Access Journals (Sweden)

    M.J. Bernardes

    2012-11-01

    Full Text Available Introduction: Reporting of ethical committee (EC approval and patient consent in publications involving human subjects may be lower than recommended. In this paper this ethical issue was analysed in the Portuguese Journal of Pulmonology and in the other two Portuguese medical journals with impact factor indexed in the ISI Web of Knowledge. Methods: Reporting of EC approval and patient consent was searched in all publications involving human subjects published in the Acta Médica Portuguesa, Acta Reumatológica Portuguesa and Portuguese Journal of Pulmonology, from the 1st July 2010 until the 30th June 2011. The search also looked for the involvement of vulnerable and potentially identifiable subjects. Results: Most of the analysed publications, which included a considerable proportion of vulnerable (23% and of potentially identifiable case reports (14%, were case reports (49%. Overall EC approval ranged from 0% to 28%, in case reports and prospective studies, respectively, whereas overall patient consent ranged from 0% to 26%. There were not statistically significant differences in results among the selected journals. Conclusions: Reporting of EC approval and patient consent in the three leading Portuguese medical journals has been lower than in their leading world counterparts. This should be taken into account and further audited in future, not only for the protection of the research subjects but also to maintain public trust in the process. Resumo: Introdução: A referência a aprovação de comissão de ética (CE e a consentimento dos doentes, nas publicações que envolvem humanos, poderá ser inferior à recomendada. Neste artigo, esta situação foi analisada na Revista Portuguesa de Pneumologia e nas outras 2 revistas médicas portuguesas com fator de impacto indexadas na ISI Web of Knowledge. Métodos: A referência a aprovação de CE e a consentimento dos doentes foi pesquisada em todas as publicações que envolveram humanos na

  9. Four Roles of Ethical Theory in Clinical Ethics Consultation.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2016-09-01

    When clinical ethics committee members discuss a complex ethical dilemma, what use do they have for normative ethical theories? Members without training in ethical theory may still contribute to a pointed and nuanced analysis. Nonetheless, the knowledge and use of ethical theories can play four important roles: aiding in the initial awareness and identification of the moral challenges, assisting in the analysis and argumentation, contributing to a sound process and dialogue, and inspiring an attitude of reflexivity. These four roles of ethical theory in clinical ethics consultation are described and their significance highlighted, while an example case is used as an illustration throughout.

  10. Los comités de ética clínica en México: la ambigua frontera entre la ética asistencial y la ética en investigación clínica Institutional ethics committees in Mexico: the ambiguous boundary between health care ethics and research ethics

    Directory of Open Access Journals (Sweden)

    Edith Valdez-Martínez

    2008-08-01

    Full Text Available OBJETIVO: Identificar los comités de ética de la práctica clínica en México y establecer las posibles implicaciones derivadas de su composición y funcionamiento. MÉTODOS: Estudio transversal descriptivo realizado entre enero y diciembre de 2005. Se envió por correo electrónico una encuesta a todos los hospitales y unidades de medicina familiar del Instituto Mexicano del Seguro Social (n = 437 y del Instituto de Seguridad y Servicios Sociales de los Trabajadores del Estado (n = 167 que contaran con más de 10 consultorios, y a los establecimientos asistenciales más importantes de la Secretaría de Salud de México (n = 15. Los elementos analizados fueron: nombre del comité, fecha en la que fue constituido, estado actual de actividad, composición, funciones y facultades. RESULTADOS: Se identificaron 116 comités con muy diversos nombres, de ellos 101 (87,1% estaban activos. Estos comités se crearon entre 1985 y 2006, con un pico entre los años 2004 y 2005. De los comités activos, 59 (58,4% se encargaban tanto de los problemas/dilemas éticos relacionados con la práctica clínica como de los proyectos de investigación. De los integrantes, 357 (59,0% tenían puestos directivos en el establecimiento al que pertenecía el comité del que eran miembros; predominó la profesión médica (71,5%, seguida de personal de enfermería (11,9%. De los integrantes de los comités activos, 77,9% no había recibido entrenamiento en el campo de la ética. CONCLUSIONES: Puede esperarse que surjan conflictos legales, principalmente en los establecimientos cuyos comités se confieren la autoridad de dictaminar el curso apropiado de una acción. Se requiere un plan integral para estandarizar la composición y los procedimientos de los comités de ética clínica en México y mejorar la preparación de sus miembros.OBJECTIVE: To identify ethics committees in medical practice in Mexico and possible implications stemming from their composition and

  11. Protestant Ethics in Academia

    Directory of Open Access Journals (Sweden)

    Anna Maria Kucharska

    2014-12-01

    Full Text Available Academic ethics has recently become an important issue in Poland. With changes in the Polish law on higher education a new approach to ethics of students and academics has been presented. As a PhD student and young researcher, I am personally interested in the introduced changes. This article seeks to examine professional academic ethics in terms of two chosen theories, that is, the Protestant work ethic of Max Weber and its adaptation to the academic environment by Robert K. Merton. I situate both theories in the Polish context of shaping the academic ethos. In my deliberations I recall Dietrich Bonhoeffer’s works as fundamental for the Protestant work ethos values, which are honesty, reliability and diligence. Additionally I present their religious as well as non religious aspects. With such theoretical foundations, I attempt to evaluate the risks and violations in the ranks of Polish academics. The theoretical basis and the collected data enable me to put forward the claim that it is not feasible in Poland to follow the Western model of work ethics. Instead, it has to be built from scratch. To start this process, we need to consider the value of responsibility as a crucial category not only for the process of academic ethos formation, but also for everyday life from the early years.

  12. A 'good' ethical review: audit and professionalism in research ethics

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2015-01-01

    How does one conduct, measure and record a ‘good’ ethical review of biomedical research? To what extent do ethics committees invoke professionalism in researchers and in themselves, and to what extent do they see competence as adherence to a set of standard operating procedures for ethical review...

  13. IS ETHICAL HACKING ETHICAL?

    OpenAIRE

    MUHAMMAD NUMAN ALI KHAN; DANISH JAMIL,

    2011-01-01

    This paper explores the ethics behind ethical hacking and whether there are problems that lie with this new field of work. Since ethical hacking has been a controversial subject over the past few years, the question remains of the true intentions of ethical hackers. The paper also looks at ways in which future research could be looked intoto help keep ethical hacking, ethical.

  14. Ethics in research

    International Nuclear Information System (INIS)

    Grass, Guido

    2014-01-01

    Taking into account the state of the science, the ethics committee has to decide in research projects with study-related radiation exposure, whether a compelling need for the research project exists. During the critical appraisal, further ethical and legal aspects have to be considered. Even without an application according to X-ray Ordinance (RoeV) or Radiation Protection Ordinance (StrlSchV), the Ethics Committee should advise the applicant whether from their perspective the project requires an approval according to RoeV and StrlSchV. This requires the regular involvement of expert members.

  15. Functional Median Polish

    KAUST Repository

    Sun, Ying

    2012-08-03

    This article proposes functional median polish, an extension of univariate median polish, for one-way and two-way functional analysis of variance (ANOVA). The functional median polish estimates the functional grand effect and functional main factor effects based on functional medians in an additive functional ANOVA model assuming no interaction among factors. A functional rank test is used to assess whether the functional main factor effects are significant. The robustness of the functional median polish is demonstrated by comparing its performance with the traditional functional ANOVA fitted by means under different outlier models in simulation studies. The functional median polish is illustrated on various applications in climate science, including one-way and two-way ANOVA when functional data are either curves or images. Specifically, Canadian temperature data, U. S. precipitation observations and outputs of global and regional climate models are considered, which can facilitate the research on the close link between local climate and the occurrence or severity of some diseases and other threats to human health. © 2012 International Biometric Society.

  16. [Ethics code of the Chilean Biological Society].

    Science.gov (United States)

    de Etica, C; Valenzuela, C; Cruz-Coke, R; Ureta, T; Bull, R

    1997-01-01

    The Chilean Biological Society has approved an ethics code for researchers, elaborated by its Ethic Committee. The text, with 16 articles, undertakes the main ethical problems that researchers must solve, such as institutional, professional or societal ethics, scientific fraud, breaches in collaborative work, relationships between researchers, participation in juries and committees, ethical breaches in scientific publications, scientific responsibility and punishments. This code declares its respect and valorization of all life forms and adheres to international biomedical ethical codes. It declares that all knowledge, created or obtained by researchers is mankind's heritage.

  17. [Project for the Creation of a Medical or Hospital Ethical Committee at a Local Level in the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama. Year 2013].

    Science.gov (United States)

    Díaz Rivera, Yashiro A

    2015-01-01

    The next project was based on the design on the creation of a medical ethical Committee at a hospital. It was developed at the San Miguel Arcangel Hospital, District of San Miguelito, Province of Panama, in 2013. Insomuch as the creation of social projects requires unified international parameters, format is taken from the Unesco's guides for the establishing and working of bioethics committees; adapted to the socio-economic, political and cultural context of the San Miguelito District, Panama Province. Furthermore to adapting to socio-ecological aspect where the research project is carried out, the theoretical aspect includes from the ontological personalistic bioethics, where the cornerstone is the dignity of the human person. A study of perceptions of medical staff and nursing was developed on the management of the most common ethical dilemmas in the Hospital San Miguel Arcángel. The instrument used was a previously validated perception survey through a pilot test. Reliability was measured using Cronbach's alpha coefficient, and validity was obtained from the content. Satisfactory statistical results, that verify the working hypotheses on the recognition of the importance of autonomy, confidentiality, protection of vulnerable population, occupational health staff welfare and integration of bioethics at the institutional agenda, were obtained. However, there were particular aspects that indicate some doubt as to the management of some realities that are presented in the context of health care.

  18. The Ethics of Breast Surgery.

    Science.gov (United States)

    Throckmorton, Alyssa; VanderWalde, Lindi; Brackett, Craig; Dominici, Laura; Eisenhauer, Thomas; Johnson, Nathalie; Kong, Amanda; Ludwig, Kandice; O'Neill, Jennifer; Pugliese, Matthew; Teller, Paige; Sarantou, Terry

    2015-10-01

    Breast surgery has evolved as a subspecialty of general surgery and requires a working knowledge of benign and malignant diseases, surgical techniques, shared decision-making with patients, collaboration with a multi-disciplinary team, and a basic foundation in surgical ethics. Ethics is defined as the practice of analyzing, evaluating, and promoting best conduct based upon available standards. As new information is obtained or as cultural values change, best conduct may be re-defined. In 2014, the Ethics Committee of the ASBrS acknowledged numerous ethical issues, specific to the practice of breast surgery. This independent review of ethical concerns was created by the Ethics Committee to provide a resource for ASBrS members as well as other surgeons who perform breast surgery. In this review, the professional, clinical, research and technology considerations that breast surgeons face are reviewed with guidelines for ethical physician behavior.

  19. Ethical Perspectives on Advertising

    OpenAIRE

    SOJKOVÁ, Eva

    2008-01-01

    In my paper I examine the practice of advertising from ethical perspective. The paper informs about the ethical regulation of advertising practice in Czech Republic and highlights its interconnection with legislative regulation. It also introduces the work of the Committee for advertising - the first organization for auto-regulation of advertising in Eastern Europe - whose goal is to ensure honest, legal, decent, truthful practice of advertising in Czech Republic. In the main part of my paper...

  20. Engineer Ethics

    Energy Technology Data Exchange (ETDEWEB)

    Lee, Dae Sik; Kim, Yeong Pil; Kim, Yeong Jin

    2003-03-15

    This book tells of engineer ethics such as basic understanding of engineer ethics with history of engineering as a occupation, definition of engineering and specialized job and engineering, engineer ethics as professional ethics, general principles of ethics and its limitation, ethical theory and application, technique to solve the ethical problems, responsibility, safety and danger, information engineer ethics, biotechnological ethics like artificial insemination, life reproduction, gene therapy and environmental ethics.

  1. Engineer Ethics

    International Nuclear Information System (INIS)

    Lee, Dae Sik; Kim, Yeong Pil; Kim, Yeong Jin

    2003-03-01

    This book tells of engineer ethics such as basic understanding of engineer ethics with history of engineering as a occupation, definition of engineering and specialized job and engineering, engineer ethics as professional ethics, general principles of ethics and its limitation, ethical theory and application, technique to solve the ethical problems, responsibility, safety and danger, information engineer ethics, biotechnological ethics like artificial insemination, life reproduction, gene therapy and environmental ethics.

  2. [Ethical issue in animal experimentation].

    Science.gov (United States)

    Parodi, André-Laurent

    2009-11-01

    In the 1970s, under pressure from certain sections of society and thanks to initiatives by several scientific research teams, committees charged with improving the conditions of laboratory animals started to be created, first in the United States and subsequently in Europe. This led to the development of an ethical approach to animal experimentation, taking into account new scientific advances. In addition to the legislation designed to provide a legal framework for animal experimentation and to avoid abuses, this ethical approach, based on the concept that animals are sentient beings, encourages greater respect of laboratory animals and the implementation of measures designed to reduce their suffering. Now, all animal experiments must first receive ethical approval--from in-house committees in the private sector and from regional committees for public institutions. Very recently, under the impetus of the French ministries of research and agriculture, the National committee for ethical animal experimentation published a national ethical charter on animal experimentation, setting the basis for responsible use of animals for scientific research and providing guidelines for the composition and functioning of ethics committees. Inspired by the scientific community itself this ethical standardization should help to assuage--but not eliminate--the reticence and hostility expressed by several sections of society.

  3. Polish Semantic Parser

    Directory of Open Access Journals (Sweden)

    Agnieszka Grudzinska

    2000-01-01

    Full Text Available Amount of information transferred by computers grows very rapidly thus outgrowing the average man's capability of reception. It implies computer programs increase in the demand for which would be able to perform an introductory classitication or even selection of information directed to a particular receiver. Due to the complexity of the problem, we restricted it to understanding short newspaper notes. Among many conceptions formulated so far, the conceptual dependency worked out by Roger Schank has been chosen. It is a formal language of description of the semantics of pronouncement integrated with a text understanding algorithm. Substantial part of each text transformation system is a semantic parser of the Polish language. It is a module, which as the first and the only one has an access to the text in the Polish language. lt plays the role of an element, which finds relations between words of the Polish language and the formal registration. It translates sentences written in the language used by people into the language theory. The presented structure of knowledge units and the shape of understanding process algorithms are universal by virtue of the theory. On the other hand the defined knowledge units and the rules used in the algorithms ure only examples because they are constructed in order to understand short newspaper notes.

  4. Health research ethics review and needs of institutional ethics ...

    African Journals Online (AJOL)

    for their time, but this was reported to be as a token and was not proportion to the workload. Monitoring of research undertaking was identified as a problem in all the research ethics committees. Sixty-nine percent of the committee members reported lack of mechanisms for monitoring of approved research while 33% did not ...

  5. 41 CFR 105-54.204 - Advisory committee membership.

    Science.gov (United States)

    2010-07-01

    ... Administrator's signature to the GSA Committee Management Officer and to the Special Counsel for Ethics and Civil Rights for review and forwarding to the Administrator. (b) Discrimination is prohibited on the... cleared by the Designated Agency Ethics Official. ...

  6. Ethical Issues in Cross-Cultural Research

    Science.gov (United States)

    Honan, Eileen; Hamid, M. Obaidul; Alhamdan, Bandar; Phommalangsy, Phouvanh; Lingard, Bob

    2013-01-01

    The gap between theoretical expectations of research ethics as outlined in the bureaucratic processes associated with University Ethics Committees and the situated realities of students undertaking studies within their own sociocultural contexts is explored in this paper. In particular, the authors investigate differences in ethical norms and…

  7. [Lysenkoism in Polish botany].

    Science.gov (United States)

    Köhler, Piotr

    2008-01-01

    Lysenkoism in Poland was never an autonomous phenomenon. The whole array of reasons for which it appeared in Polish science would require a separate study--here it only needs to be pointed out that the major reasons included terror on the part of the security service, lawlessness, the ubiquitous atmosphere of intimidation and terror, censorship, the diminishing sphere of civil liberties, political show trials, propaganda and denunciations. An important role in facilitating the introduction of Lysenkoism was played also by the reorganization of science after World War Two, the isolation of Polish science from science in the West, as well as the damage it had suffered during the war. At first, Lysenkoism was promoted in Poland by a small group of enthusiastic and uncritical proponents. A overview of the events connected with the ten years of Lysenkoism in Poland (end of 1948--beginning of 1958) shows a two-tier picture of how the 'idea' was propagated. The first tier consisted in the activities of the Association of Marxist Naturalists [Koło Przyrodników-Marksistów], which it engaged in since the end of 1948. The Association was later transformed into a Union of Marxist Naturalists, and this in turn merged, in 1952, with the Copernican Society of Polish Naturalists [Polskie Towarzystwo Przyrodników im. Kopernika]. It was that society which promoted Lysenkoism longest, until the end of 1956. The propaganda and training activities of the circle and the society prepared ground for analogous activities of the newly formed Polish Academy of Science (PAN), which--since its very establishment in 1952--engaged in promoting Lysenkoism through its Second Division. These activities were aimed at naturalists, initially at those who were prominent scientists (eg. the conference at Kuźnice, 1950/1951), and then at those who were only starting their academic career (including national courses in new biology at Dziwnów, 1952, or Kortowo, 1953 and 1955). The end to promoting

  8. Challenges in the Ethical Review of Peer Support Interventions

    Science.gov (United States)

    Simmons, David; Bunn, Christopher; Nakwagala, Fred; Safford, Monika M.; Ayala, Guadalupe X.; Riddell, Michaela; Graffy, Jonathan; Fisher, Edwin B.

    2015-01-01

    PURPOSE Ethical review processes have become increasingly complex. We have examined how 8 collaborating diabetes peer-support clinical trials were assessed by ethics committees. METHODS The ethical reviews from the 8 peer-support studies were collated and subjected to a thematic analysis. We mapped the recommendations of local Institutional Review Boards and ethics committees onto the “4+1 ethical framework” (autonomy, beneficence, non-maleficence, and justice, along with concern for their scope of application). RESULTS Ethics committees did not consistently focus on tasks within the 4+1 framework: many conducted reviews of scientific, organizational, and administrative activities. Of the 20 themes identified across the ethical reviews, only 4 fell within the scope of the 4+1 framework. Variation in processes and requirements for ethics committees were particularly evident between study countries. Some of the consent processes mandated by ethical review boards were disproportionate for peer support, increased participant burden, and reduced the practicality of testing an ethical intervention. Across the 8 studies, ethics committees’ reviews included the required elements to ensure participant safety; however, they created a range of hurdles that in some cases delayed the research and required consent processes that could hinder the spontaneity and/or empathy of peer support. CONCLUSION Ethics committees should avoid repeating the work of other trusted agencies and consider the ethical validity of “light touch” consent procedures for peer-support interventions. The investigators propose an ethical framework for research on peer support. PMID:26304976

  9. Ethical Guidelines and Practices for US Military Medical Professionals

    Science.gov (United States)

    2015-03-03

    symposium has brought together the Walter Reed-Bethesda Ethics Committee and the Department of Pastoral Care to provide education and training...University of the Health Sciences;2006. 138. Walter Reed-Bethesda Ethics Committee and Department of Pastoral Care . Annual Healthcare Ethics...Association, Council on Ethical and Judicial Affairs  CAPT Roosevelt Brown, Chaplain of Navy Medicine, Pastoral Care Office, Bureau of Medicine and

  10. Subjective Quality of Life of Polish, Polish-Immigrant, and Polish-American Elderly.

    Science.gov (United States)

    Berdes, Celia; Zych, Adam A.

    2000-01-01

    Compares subjective quality of life of elderly Poles living in Poland, and Polish immigrants and Polish-American ethnics living in Chicago as part of a secondary data analysis of a study initially conducted in Poland. Conclusions lend support to the idea that U.S.-born elderly people and elderly immigrants to the United States have a significantly…

  11. Tooth polishing: The current status

    Directory of Open Access Journals (Sweden)

    Madhuri Alankar Sawai

    2015-01-01

    Full Text Available Healthy teeth and gums make a person feel confident and fit. As people go about their daily routines and with different eating and drinking habits, the tooth enamel turns yellowish or gets stained. Polishing traditionally has been associated with the prophylaxis procedure in most dental practices, which patients know and expect. However, with overzealous use of polishing procedure, there is wearing of the superficial tooth structure. This would lead to more accumulation of local deposits. Also, it takes a long time for the formation of the fluoride-rich layer of the tooth again. Hence, now-a-days, polishing is not advised as a part of routine oral prophylaxis procedure but is done selectively based on the patients′ need. The article here, gives an insight on the different aspects of the polishing process along with the different methods and agents used for the same.

  12. Lysenko affair and Polish botany.

    Science.gov (United States)

    Köhler, Piotr

    2011-01-01

    This article describes the slight impact of Lysenkoism upon Polish botany. I begin with an account of the development of plant genetics in Poland, as well as the attitude of scientists and the Polish intelligentsia toward Marxist philosophy prior to the World War II. Next I provide a short history of the introduction and demise of Lysenkoism in Polish science, with a focus on events in botany, in context with key events in Polish science from 1939 to 1958. The article outlines the little effects of Lysenkoism upon botanists and their research, as well as how botanists for the most part rejected what was often termed the "new biology." My paper shows that though Lysenko's theories received political support, and were actively promoted by a small circle of scientists and Communist party activists, they were never accepted by most botanists. Once the political climate in Poland altered after the events of 1956, Lysenko's theories were immediately abandoned.

  13. Elastic emission polishing

    Energy Technology Data Exchange (ETDEWEB)

    Loewenthal, M.; Loseke, K.; Dow, T.A.; Scattergood, R.O.

    1988-12-01

    Elastic emission polishing, also called elastic emission machining (EEM), is a process where a stream of abrasive slurry is used to remove material from a substrate and produce damage free surfaces with controlled surface form. It is a noncontacting method utilizing a thick elasto-hydrodynamic film formed between a soft rotating ball and the workpiece to control the flow of the abrasive. An apparatus was built in the Center, which consists of a stationary spindle, a two-axis table for the workpiece, and a pump to circulate the working fluid. The process is controlled by a programmable computer numerical controller (CNC), which presently can operate the spindle speed and movement of the workpiece in one axis only. This apparatus has been used to determine material removal rates on different material samples as a function of time, utilizing zirconium oxide (ZrO{sub 2}) particles suspended in distilled water as the working fluid. By continuing a study of removal rates the process should become predictable, and thus create a new, effective, yet simple tool for ultra-precision mechanical machining of surfaces.

  14. THE POLISH RECIPE

    Directory of Open Access Journals (Sweden)

    D.F. Spinu

    2017-06-01

    Full Text Available Twenty-six years ago the international community witnessed one of the most dramatic changes in economic systems. Naturally, the fall of communism in Eastern Europe and its consequences were events difficult to judge and anticipate in their immediate aftermath. Today, we have gained a much more coherent perspective on their meaning. The political liberalization of Poland in 1989 and its transition to the market economy was generally perceived as the most successful of all post-communist countries. From 1990 to 2013, Poland experienced the most outstanding economic growth within the former communist bloc. It doubled its GDP in real terms and became the only country to experience economic growth during the financial crisis of 2008-09. However, the polish secret recipe lies in the "shock therapy" adopted at the beginning of the 90's. The aim of this paper is to examine the importance of the Balcerowicz's program in creating the basis for economic stability and growth through privatization, liberalization of foreign trade, monetary reform and an open economy. We will also review the impact of this unprecedented transformation in shaping a strong, market-oriented economy.

  15. Building Capacity in Ethical Review

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2017-01-01

    Capacity building in biomedical research ethics review has been a European priority since the early 2000s. Prompted by the increase in data originating in internationally sponsored trials in emerging economies, a range of capacity building initiatives were put in place in the field of ethical...... review to ensure the protection of human subjects participating in research. Drawing on fieldwork with the Forum for Ethical Review Committees in the Asian and Western Pacific Region, I explore two distinct forms taken by capacity building within that organization to support and train members of ethics...... review committees. The first, with an emphasis on standards and measurability, takes as its priority international accountability for clinical trial research. e second explores how the organization goes about persuading trainees to see and do ‘ethics’ differently. is distinction between forms of capacity...

  16. JPRS Report, East Europe. Reference Aid: Abbreviations in the Polish Press.

    Science.gov (United States)

    1989-12-07

    Regional Commission for the Defense (of Solidarity) International Committee of [Former Inmates of] Auschwitz Interfactory Organizational...Organization for Artistic Performances Pomeranian Foundry and Enamelling Plant single room State Center for the Education of Librarians ...IN THE POLISH PRESS REPRODUCED BY U.S. DEPARTMENT OF COMMERCE NATIONAL TECHNICAL INFORMATION SERVICE SPRINGFIELD, VA. 22161 CVJ m ■crai.-JWiMds

  17. Polish Toxic Currency Options

    Directory of Open Access Journals (Sweden)

    Waldemar Gontarski

    2009-04-01

    Full Text Available Toxic currency options are defined on the basis of the opposition to the nature (essence of an option contract, which is justified in terms of norms founded on the general law clause of characteristics (nature of a relation (which represents an independent premise for imposing restrictions on the freedom of contracts. So-understood toxic currency options are unlawful. Indeed they contravene iuris cogentis regulations. These include for instance option contracts, which are concluded with a bank, if the bank has not informed about option risk before concluding the contract; or the barrier options, which focus only on the protection of banks interests. Therefore, such options may appear to be invalid. Therefore, performing contracts for toxic currency options may be qualified as a criminal mismanagement. For the sake of security, the manager should then take into consideration filing a claim for stating invalidity (which can be made in a court verdict. At the same time, if the supervisory board member in a commercial company, who can also be a subject to mismanagement offences, commits an omission involving lack of reaction (for example, if he/she fails to notify of the suspected offence committed by the management board members acting to the companys detriment when the management board makes the company conclude option contracts which are charged with absolute invalidity the supervisory board member so acting may be considered to act to the companys detriment. In the most recent Polish jurisprudence and judicature the standard of a good host is treated to be the last resort for determining whether the managers powers resulting from criminal regulations were performed. The manager of the exporter should not, as a rule, issue any options. Issuing options always means assuming an obligation. In the case of currency put options it is an absolute obligation to purchase a given amount in euro at exchange rate set in advance. On the other hand issuing

  18. Ethical Issues in Research: How Harmful is Deception?

    Science.gov (United States)

    Smith, Charles P.; And Others

    One function of a Human Subjects Committee is to review the possible adverse effects of ethically problematic experiments. The concerns of an institutional review committee about the possible adverse effects of an ethically-problematic "cheating" study were examined with regard to the actual effects reported by the subjects. Retrospective…

  19. How to make an ethics review process more effective and efficient? : A proposal of Ethics Review Worksheet for REC members

    OpenAIRE

    田代, 志門; 松井, 健志

    2016-01-01

    A research ethics committee (REC) has its paramount function in protecting human subjects in medical research. In this article, we propose and explain how to use the Ethics Review Worksheet that we have developed in order to make ethics review process more effective and efficient. Characteristically, the Worksheet is composed of a comprehensive checklist of important viewpoints based on research ethics theories, and also carefully designed to follow the actual process of ethics review. With t...

  20. Premature Discontinuation of Prospective Clinical Studies Approved by a Research Ethics Committee - A Comparison of Randomised and Non-Randomised Studies.

    Directory of Open Access Journals (Sweden)

    Anette Blümle

    Full Text Available Premature discontinuation of clinical studies affects about 25% of randomised controlled trials (RCTs which raises concerns about waste of scarce resources for research. The risk of discontinuation of non-randomised prospective studies (NPSs is yet unclear.To compare the proportion of discontinued studies between NPSs and RCTs that received ethical approval.We systematically surveyed prospective longitudinal clinical studies that were approved by a single REC in Freiburg, Germany between 2000 and 2002. We collected study characteristics, identified subsequent publications, and surveyed investigators to elucidate whether a study was discontinued and, if so, why.Of 917 approved studies, 547 were prospective longitudinal studies (306 RCTs and 241 NPSs. NPSs were on average smaller than RCTs, more frequently single centre and pilot studies, and less frequently funded by industry. NPSs were less frequently discontinued than RCTs: 32/221 (14% versus 78/288 (27%, p<0.001, missing data excluded. Poor recruitment was the most frequent reason for discontinuation in both NPSs (36% and RCTs (37%.Compared to RCTs, NPSs were at lower risk for discontinuation. Measures to reliably predict, sustain, and stimulate recruitment could prevent discontinuation of many RCTs but also of some NPSs.

  1. Committee on Scientific Values | Initiatives | Indian Academy of ...

    Indian Academy of Sciences (India)

    Academy Committee on Scientific Values. The Council of the Academy had in 2003 constituted a Committee to consider and submit a report on ethical guidelines which the fellowship of the Academy should follow. The Committee submitted its report to the Council, which at its meeting in December 2005 approved this report ...

  2. Efficient polishing of aspheric optics

    Energy Technology Data Exchange (ETDEWEB)

    Taylor, J.S.; Piscotty, M.A.; Nguyen, N.Q.; Landram, C.S.; Ng, L.C.

    1997-04-15

    The objectives of this project are to develop, evaluate, and optimize novel designs for a polishing tool intended for ultra-precise figure corrections on aspheric optics with tolerances typical of those required for use in extreme ultraviolet (EUV) projection lithography. This work may lead to an enhanced US industrial capability for producing optics for EUV, x-ray and, other high precision applications. LLNL benefits from developments in computer-controlled polishing and the insertion of fluid mechanics modeling into the precision manufacturing area. Our accomplishments include the numerical estimation of the hydrodynamic shear stress distribution for a new polishing tool that directs and controls the interaction of an abrasive slurry with an optical surface. A key milestone is in establishing a correlation between the shear stress predicted using our fluid mechanics model and the observed removal footprint created by a prototype tool. In addition, we demonstrate the ability to remove 25 nm layers of optical glass in a manner qualitatively similar to macroscopic milling operations using a numerically- controlled machine tool. Other accomplishments include the development of computer control software for directing the polishing tool and the construction of a polishing testbed.

  3. AGU Committees

    Science.gov (United States)

    Administrative Committees are responsible for those functions required for the overall performance or well-being of AGU as an organization. These committees are Audit and Legal Affairs, Budget and Finance*, Development, Nominations*, Planning, Statutes and Bylaws*, Tellers.Operating Committees are responsible for the policy direction and operational oversight of AGU's primary programs. The Operating Committees are Education and Human Resources, Fellows*, Information Technology, International Participation*, Meetings, Public Affairs, Public Information, Publications*.

  4. Ethics in Early Childhood Special Education.

    Science.gov (United States)

    Bowe, Frank G.

    1995-01-01

    This article discusses ethical questions in providing prenatal services, including testing and genetic engineering, and medical interventions with neonates and other very young children who have severe disabilities. It explores ways to enhance ethical decision making, including recruitment for multidisciplinary teams or other committees of adults…

  5. [Ethics and animal experiments.].

    Science.gov (United States)

    Schnaider, Taylor Brandão; Souza, Cláudio de

    2003-04-01

    This is a major subject since the aim is to grant human beings physical, mental, social and spiritual well-being without forgetting the sacred rights of all animals. Most international codes dealing with health-related research practices state that research developed in human beings should be based on previous lab animal experiments or on other scientific data. This article aimed at explaining ethics in animal experiments. The concepts of dissertation and thesis, experimental thesis, experimental essay or pilot experiment and experimental animal facilities are reviewed. Then, a historical retrospective is drawn about the first attempt to develop experimental research policies during the mid 19th Century, in London. It is highlighted that some criteria defined by that time still persist. The first animal research ethical committee was created in Sweden in 1979, followed by the USA in1984. In Brazil, animal research ethical committees were created as late as in the 90s. The Federal Law 6638 was passed in May 1979 and provides for the didactic-scientific practice of animal vivisection. This law, however, is still waiting for regulation. In addition, there are some drafts being analyzed by the Congress, which provide for the use of animals for teaching and research purposes. Finally, the policies adopted by the Brazilian College of Animal Experiments and the Universal Declaration of Animal Rights are presented. Professors, postgraduates, residents and graduate students of a Medical School involved in animal research should be aware of the ethical principles aiming at protecting animals selected for scientific work.

  6. Business ethics

    OpenAIRE

    Csillag,Paula

    1998-01-01

    The goal of this paper is to present examples of business ethics issues. What is business ethics, things concerned in this field are and why it is needed and important when doing business? The concept of business ethics has connotations to provision, rules and standards in directing the behavior of actors in the business. Business ethics involves compliance with the law, the implementation of ethical responsibilities of a business, the protection of the rights of those who are related to the ...

  7. Cannabinoids cases in polish athletes

    OpenAIRE

    A Pokrywka; Z Obmiński; D Kwiatkowska; R Grucza

    2009-01-01

    The aim of this study was to investigate the number of cases and the profiles of Polish athletes who had occasionally been using marijuana or hashish throughout the period of 1998-2004, with respect to: sex, age, and discipline of sport as well as the period of testing (in- and out-of-competition). Results of the study were compared with some data reported by other WADA accredited anti-doping laboratories. Totally, 13 631 urine samples taken from Polish athletes of both sexes, aged 10-67 year...

  8. Implications of the ethical-legal framework for adolescent HIV ...

    African Journals Online (AJOL)

    Nicky

    Fourthly, the institutional framework for establishing research priorities and regulation of ethical review is being strengthened with the establishment of new institutions such as the National. Health Research Ethics Committee. The South African ethical-legal framework and its implications for adolescent HIV vaccine trials ...

  9. Ethics and originality in doctoral research in the UK.

    Science.gov (United States)

    Snowden, Austyn

    2014-07-01

    To show that the ethics governance process in the UK is not necessarily conducive to innovative investigation by doctoral students. Doctoral students need to demonstrate an original contribution to knowledge. This paper critically evaluates the concept of knowledge in relation to the concept of research paradigms. The purpose of this is to situate different claims to originality and show that original knowledge in nursing is always ethical knowledge of nursing. Academic databases, local and national policy documents. Ethics governance procedures in nurse research in the UK are summarised. These are contrasted with ethical issues embedded in day-to-day nursing practice. The author's argument is that current methods of ethics governance for doctoral research in the UK can be detrimental to the construction of original knowledge in nursing. This is because original research in nursing necessarily affects the ethics of care, but the gatekeeping function of risk-averse ethics committees tends to prevent students attempting ethically complex studies. This means less important research gets carried out. To mitigate these issues, doctoral students need to develop a solid understanding of the ethics governance process. They need to build relationships with relevant ethics committees. University ethics committees are ideally placed to help with this process. Without original research practice will remain reactive. Originality entails risk on the part of both researcher and ethics committee. Positive risk taking is more feasible in the context of collaboration and mutual understanding. Nurses should become more active in research governance.

  10. Polish-Bulgarian-Russian, Bulgarian-Polish-Russian or Russian-Bulgarian-Polish dictionary?

    Directory of Open Access Journals (Sweden)

    Violetta Koseska-Toszewa

    2015-11-01

    Full Text Available Polish-Bulgarian-Russian, Bulgarian-Polish-Russian or Russian-Bulgarian-Polish dictionary? The trilingual dictionary (M. Duszkin, V. Koseska, J. Satoła and A. Tzoneva is being elaborated based on a working Polish-Bulgarian-Russian electronic parallel corpus authored by Maksim Duszkin, Violetta Koseska-Toszewa and Joanna Satoła-Staśkowiak, and works by A. Tzoneva. It is the first corpus comparing languages belonging to three different Slavic language groups: western, southern and eastern. Works on the dictionary are based on Gramatyka konfrontatywna bułgarsko-polska (Bulgarian-Polish confrontative grammar and the proposed there semantic-oriented interlanguage. Two types of classifiers have been introduced into the dictionary: classic and semantic. The trilingual dictionary will present a consistent and homogeneous set of facts of grammar and semantics. The Authors point out that in a traditional dictionary it is not clear for example whether aspect should be understood as imperfective / perfective form of a verb or as its meaning. Therefore in the dictionary forms and meaning are separated in a regular way. Imperfective verb form has two meanings: state and configuration of states and events culminating in state. Also perfective verb form has two meanings: event and configuration of states and events culminating in event. These meanings are described by the semantic classifiers, respectively, state and event, state1 and event1. The way of describing language units, mentioned in the article, gives a possibility to present language material (Polish, Bulgarian, Russian in any required order, hence the article’s title.

  11. 75 FR 42680 - Agenda and Notice of Public Meeting of the Colorado Advisory Committee

    Science.gov (United States)

    2010-07-22

    ... is for the committee to participate in orientation and ethics training; discuss recent Commission and... Committee will also be briefed by the director of a city anti-discrimination agency and a representative of...

  12. Cannabinoids cases in polish athletes

    Directory of Open Access Journals (Sweden)

    A Pokrywka

    2009-07-01

    Full Text Available The aim of this study was to investigate the number of cases and the profiles of Polish athletes who had occasionally been using marijuana or hashish throughout the period of 1998-2004, with respect to: sex, age, and discipline of sport as well as the period of testing (in- and out-of-competition. Results of the study were compared with some data reported by other WADA accredited anti-doping laboratories. Totally, 13 631 urine samples taken from Polish athletes of both sexes, aged 10-67 years, performing 46 disciplines of sport were tested. Cannabinoids were detected in 267 samples. Among Polish athletes the relative number of positive THC (tetrahydrocannabinol samples was one of the highest in Europe. The group of young Polish athletes (aged 16-24 years was the most THC-positive. THC-positive cases were noted more frequently in male athletes tested during out of competitions. The so-called contact sports (rugby, ice hockey, skating, boxing, badminton, body building and acrobatic sports were those sports, where the higher risk of cannabis use was observed. The legal interpretation of some positive cannabinoids results would be difficult because of some accidental and unintentional use of the narcotics by sportsmen. It was concluded that national anti-doping organizations (NADO’s, which are competent to judge whether the anti-doping rules were violated, should take into account the possibility of non-intentional doping use of cannabinoids via passive smoking of marijuana.

  13. Sensing roughness and polish direction

    DEFF Research Database (Denmark)

    Jakobsen, Michael Linde; Olesen, Anders Sig; Larsen, Henning Engelbrecht

    2016-01-01

    needs information about the RMS-value of the surface roughness and the current direction of the scratches introduced by the polishing process. The RMS-value indicates to the operator how far he is from the final finish, and the scratch orientation is often specified by the customer in order to avoid...... structures and light scattered from scratches....

  14. Assessing the animal ethics review process

    DEFF Research Database (Denmark)

    Varga, O.; Sandøe, Peter; Olsson, I.A.S.

    2012-01-01

    Although animal experiments play an important role in biomedical research, their use is ethically challenging. Primarily in Europe, North America and Australasia ethics committees are set up to control the animal use in science. Project approval is usually decided on a case-by-case basis with focus...... on ensuring that the animals are caused a minimum of harm relative to the possibility of achieving beneficial results. Even though rules in this area are reasonably uniform there seems to be significant room for differences, individual and culturally based, between ethics committees concerning how the rules...... are applied. Our aim was to conduct a review of empirical studies of the different kinds of animal ethics committees in order to clarify what is known about their operation and highlight information which is missing in their evaluation. Our main findings are that there is a significant variation in process...

  15. Critical Analysis of Assessment Studies of the Animal Ethics Review Process †

    OpenAIRE

    Varga, Orsolya

    2013-01-01

    Simple Summary In many countries, the approval of animal research projects depends on the decisions of the ethics committees which review the projects. Since the efficiency of the protection of experimental animals greatly depends on the performance of the ethics committees, its regular assessment is crucial. This paper reviews the results of studies assessing the performance of the ethics committees, and emphasizes the importance of outcome assessment in the evaluation of the performance of ...

  16. Social Workers' Participation in the Resolution of Ethical Dilemmas in Hospice Care

    Science.gov (United States)

    Csikai, Ellen L.

    2004-01-01

    Ethical dilemmas are inherent in every health care setting. A sample of hospice social workers with no direct access to a hospice ethics committee (N = 110) was surveyed regarding ethical issues in hospice care, how the issues were managed, and the extent to which social workers participated in resolution of ethical dilemmas. Common issues…

  17. Ethics Leadership in Research, Healthcare and Organizational Systems: Commentary and Critical Reflections

    Science.gov (United States)

    Gabriele, Edward F.

    2011-01-01

    In the last decades there has arisen a greater awareness of the ever present need for critical academic reflection on the nature of ethics leadership and committees in research, healthcare, and organizational systems. Yet what is meant by ethics itself? How is ethics understood as a historical phenomenon? What challenges must ethics leaders face…

  18. Perspectives on Applied Ethics

    OpenAIRE

    2007-01-01

    Applied ethics is a growing, interdisciplinary field dealing with ethical problems in different areas of society. It includes for instance social and political ethics, computer ethics, medical ethics, bioethics, envi-ronmental ethics, business ethics, and it also relates to different forms of professional ethics. From the perspective of ethics, applied ethics is a specialisation in one area of ethics. From the perspective of social practice applying eth-ics is to focus on ethical aspects and ...

  19. Project ethics

    CERN Document Server

    Jonasson, Haukur Ingi

    2013-01-01

    How relevant is ethics to project management? The book - which aims to demystify the field of ethics for project managers and managers in general - takes both a critical and a practical look at project management in terms of success criteria, and ethical opportunities and risks. The goal is to help the reader to use ethical theory to further identify opportunities and risks within their projects and thereby to advance more directly along the path of mature and sustainable managerial practice.

  20. Ethical Impotence

    Science.gov (United States)

    Sternberg, Robert J.

    2015-01-01

    Ethical impotence occurs when one wants to act ethically but feels powerless to do anything about the perceived unethical behavior. One may feel that one's actions will have no impact or that those actions actually will have harmful consequences to oneself and/or others. Ethical impotence can be understood in terms of an eight-step model of…

  1. Medical Ethics

    Science.gov (United States)

    ... area in medicine that doesn't have an ethical aspect. For example, there are ethical issues relating to End of life care: Should ... orders? Abortion: When does life begin? Is it ethical to terminate a pregnancy with a birth defect? ...

  2. Ethical leadership

    NARCIS (Netherlands)

    den Hartog, D.N.

    2015-01-01

    High-profile cases of leaders’ ethical failure in different settings and sectors have led to increased attention to ethical leadership in organizations. In this review, I discuss the rapidly developing field of ethical leadership from an organizational behavior/psychology perspective, taking a

  3. Ethical considerations in biomedical research: a personal view.

    Science.gov (United States)

    Dahlöf, Carl

    2013-06-01

    Ethical considerations are made when an experiment is planned and take a regulatory system of moral principles into account. Ethical considerations should first and foremost be made in order to protect the individual subject/animal from being exposed to any unethical and perhaps even illegal intervention and to ensure that the experimental conditions used are appropriate. The main role of research ethics committees is to assess the scientific and ethical aspects of submitted protocols and follow up the trial until its closure.

  4. [Medical ethics as professional ethics].

    Science.gov (United States)

    Kwon, Ivo

    2012-09-25

    Contemporary medical ethics is far from the traditional concept of "In-Sul (benevolent art)" or "Yul-Li (倫, ethics), which emphasizes so much the personality or the character of a doctor. Nowadays, medical ethics should be considered as "professional ethics" which regulates the acts and medical practices of ordinary doctors in their daily practice. The key concepts of the professional ethics are "autonomy", "integrity", and "professional standard" established by medical organizations such as medical societies or associations. Most of Korean doctors have not been familiar with the concept of professional ethics or professionalism, which is due to the modern history of Korea. However, the concept of professional ethics is really critical to Korean doctors from the perspective of professional dignity and social respect to this profession. The current healthcare system of Korea is suffering from many problems of both private and public sector. Nonetheless, the professional ethics is urgently demanded for that very reason.

  5. The Ethics of Doing Ethics.

    Science.gov (United States)

    Hansson, Sven Ove

    2017-02-01

    Ethicists have investigated ethical problems in other disciplines, but there has not been much discussion of the ethics of their own activities. Research in ethics has many ethical problems in common with other areas of research, and it also has problems of its own. The researcher's integrity is more precarious than in most other disciplines, and therefore even stronger procedural checks are needed to protect it. The promotion of some standpoints in ethical issues may be socially harmful, and even our decisions as to which issues we label as "ethical" may have unintended and potentially harmful social consequences. It can be argued that ethicists have an obligation to make positive contributions to society, but the practical implications of such an obligation are not easily identified. This article provides an overview of ethical issues that arise in research into ethics and in the application of such research. It ends with a list of ten practical proposals for how these issues should be dealt with.

  6. Polish energy-system modernisation

    International Nuclear Information System (INIS)

    Drozdz, M.

    2003-01-01

    The Polish energy-system needs intensive investments in new technologies, which are energy efficient, clean and cost effective. Since the early 1990s, the Polish economy has had practically full access to modern technological devices, equipment and technologies. Introducing new technologies is a difficult task for project teams, constructors and investors. The author presents a set of principles for project teams useful in planning and energy modernisation. Several essential features are discussed: Energy-efficient appliances and systems; Choice of energy carriers, media and fuels; Optimal tariffs, maximum power and installed power; Intelligent, integrated, steering systems; Waste-energy recovery; Renewable-energy recovery. In practice there are several difficulties connected with planning and realising good technological and economic solutions. The author presents his own experiences of energy-system modernisation of industrial processes and building new objects. (Author)

  7. FINANCIAL SECURITY OF POLISH HOUSEHOLDS

    Directory of Open Access Journals (Sweden)

    Agnieszka Kozera

    2016-09-01

    Full Text Available  A household’s fi nancial security is essential for the satisfaction of the needs and wants of its members, both communal and individual. It constitutes a kind of foundation for all of a household’s fi nancial decisions that impact its standard of living. The article aims to assess the level of fi nancial security of Polish households in 2005–2013. The research draws on data from Genworth Index, HBS conducted by the Central Statistical Offi ce (GUS and Social Diagnosis (Diagnoza społeczna overseen by the Social Monitoring Council. The study shows that Poland is characterized by a low level of fi nancial security relative to other European countries, especially Western and Scandinavian. More than three-quarters of Polish households experience fi nancial problems and exhibit both a low propensity to save, and low savings rates.

  8. Energy savings in Polish buildings

    Energy Technology Data Exchange (ETDEWEB)

    Markel, L.C.; Gula, A.; Reeves, G.

    1995-12-31

    A demonstration of low-cost insulation and weatherization techniques was a part of phase 1 of the Krakow Clean Fossil Fuels and Energy Efficient Project. The objectives were to identify a cost-effective set of measures to reduce energy used for space heating, determine how much energy could be saved, and foster widespread implementation of those measures. The demonstration project focused on 4 11-story buildings in a Krakow housing cooperative. Energy savings of over 20% were obtained. Most important, the procedures and materials implemented in the demonstration project have been adapted to Polish conditions and applied to other housing cooperatives, schools, and hospitals. Additional projects are being planned, in Krakow and other cities, under the direction of FEWE-Krakow, the Polish Energie Cities Network, and Biuro Rozwoju Krakowa.

  9. Earnings Management in Polish Companies

    OpenAIRE

    Brzeszczyński, Janusz; Gajdka, Jerzy; Schabek, Tomasz

    2012-01-01

    This paper presents results of the investigation of a phenomenon known as "earnings management'' (EM) among the companies listed on the Polish stock market. The distribution of earnings per share (EPS) for the stocks around the threshold value of "zero" and the threshold of "recent performance" was analyzed in the period of years 1997-2010. Moreover, the changes of earnings for the stocks, which are suspected to manipulate their earnings, were also investigated. The results, which indicate as...

  10. LOVE in English and Polish

    Directory of Open Access Journals (Sweden)

    Małgorzata Brożyna Reczko

    2017-12-01

    Full Text Available LOVE in English and Polish The paper presents a sample contrastive analysis of the linguistic picture of love in English and Polish. The material used in the survey is drawn from lexicographic data, including the British National Corpus and Narodowy Korpus Języka Polskiego [National Corpus of Polish]. The paper focuses on the similarities and differences in conceptualizing the abstract concept of love in the English and Polish languages. An analytical method, developed by Bartmiński and associates, serves as the theoretical basis for the reconstruction of the linguistic picture of the world.   MIŁOŚĆ w języku angielskim i polskim Niniejszy artykuł to próba kontrastywnego porównania językowego obrazu świata MIŁOŚCI w języku angielskim i polskim. Materiał badawczy pochodzi głównie ze źródeł leksykograficznych: słowników oraz korpusów (Narodowego Korpusu Języka Polskiego oraz z korpusu języka angielskiego British National Corpus. Celem badania było poszukiwanie podobieństw i różnic w konceptualizacji MIŁOŚCI w tych dwóch językach. Metoda badawcza została zaczerpnięta z prac J. Bartmińskiego i dotyczy rekonstrukcji językowego obrazu świata różnych pojęć.

  11. Directly polished lightweight aluminum mirror

    Science.gov (United States)

    ter Horst, Rik; Tromp, Niels; de Haan, Menno; Navarro, Ramon; Venema, Lars; Pragt, Johan

    2017-11-01

    During the last ten years, Astron has been a major contractor for the design and manufacturing of astronomical instruments for Space- and Earth based observatories, such as VISIR, MIDI, SPIFFI, X-Shooter and MIRI. Driven by the need to reduce the weight of optically ultra-stiff structures, two promising techniques have been developed in the last years: ASTRON Extreme Lightweighting [1][2] for mechanical structures and an improved Polishing Technique for Aluminum Mirrors. Using one single material for both optical components and mechanical structure simplifies the design of a cryogenic instrument significantly, it is very beneficial during instrument test and verification, and makes the instrument insensitive to temperature changes. Aluminum has been the main material used for cryogenic optical instruments, and optical aluminum mirrors are generally diamond turned. The application of a polishable hard top coating like nickel removes excess stray light caused by the groove pattern, but limits the degree of lightweighting of the mirrors due to the bi-metal effect. By directly polishing the aluminum mirror surface, the recent developments at Astron allow for using a non-exotic material for light weighted yet accurate optical mirrors, with a lower surface roughness ( 1nm RMS), higher surface accuracy and reduced light scattering. This paper presents the techniques, obtained results and a global comparison with alternative lightweight mirror solutions. Recent discussions indicate possible extensions of the extreme light weight technology to alternative materials such as Zerodur or Silicon Carbide.

  12. An Overview of Polish Martial Arts

    Directory of Open Access Journals (Sweden)

    Wojciech J. Cynarski

    2012-07-01

    Full Text Available The purpose of this study is to explain the revival of Polish martial arts from the perspectives of cultural sociology, the sciences of physical culture, and the humanistic theory of martial arts. The Polish Martial Arts (Polskie Sztuki Walki are a subject still requiring serious scientific examination, even in Poland. There are few works concerning the history of Polish weapons, and most only describe techniques for wielding specific types of edged weapons. Nevertheless, there is a large group of enthusiasts trying to restore and cultivate the old Polish tradition, a tradition with heavy emphasis on the art of fencing. The author knows many of the people and facts presented here, from personal observation and from direct participation in these arts. As a disciple of the late Master Yoshio Sugino (10th-dan Kobudo Katori Shinto-ryu, he fought against the Polish saber champion, and he has taken part in joint exhibitions of Polish and Japanese fencing.

  13. Ethics review in compassionate use.

    Science.gov (United States)

    Borysowski, Jan; Ehni, Hans-Jörg; Górski, Andrzej

    2017-07-24

    Compassionate use is the use of unapproved drugs outside of clinical trials. So far, compassionate use regulations have been introduced in the US, Canada, many European countries, Australia and Brazil, and treatment on a compassionate use basis may be performed in Japan and China. However, there are important differences between relevant regulations in individual countries, particularly that approval by a research ethics committee (institutional review board) is a requirement for compassionate use in some countries (e.g. the US, Spain, and Italy), but not in others (e.g. Canada, the UK, France, and Germany). The main objective of this article is to present aspects of compassionate use that are important for the discussion of the role of research ethics committees in the review of compassionate use. These aspects include the nature of compassionate use, potential risks to patients associated with the use of drugs with unproven safety and efficacy, informed consent, physicians' qualifications, and patient selection criteria. Our analysis indicates that the arguments for mandatory review substantially outweigh the arguments to the contrary. Approval by a research ethics committee should be obligatory for compassionate use. The principal argument against mandatory ethical review of compassionate use is that it is primarily a kind of treatment rather than biomedical research. Nonetheless, compassionate use is different from standard clinical care and should be subject to review by research ethics committees. First, in practice, compassionate use often involves significant research aspects. Second, it is based on unapproved drugs with unproven safety and efficacy. Obtaining informed consent from patients seeking access to unapproved drugs on a compassionate use basis may also be difficult. Other important problems include the qualifications of the physician who is to perform treatment, and patient selection criteria.

  14. The tourism attractiveness of Polish libraries

    OpenAIRE

    Miedzińska, Magdalena; Tanaś, Sławoj

    2009-01-01

    The aim of the article is to draw the reader's attention to the tourism attractiveness of renowned Polish libraries. These have attained a tourism function due to tourism exploration and penetration, but remain in the shadow of other Polish cultural assets. The article outlines the historical geography of Polish libraries, an analysis of tourism assets and an attempt to classify and catalogue libraries in Poland.

  15. Cost comparison of selected US and Polish coal mines, August 1993

    International Nuclear Information System (INIS)

    1993-08-01

    This report on the Polish coal industry is the fifth in a series of studies on coal exporting countries requested by the House Appropriations Committee. The committee requested that the basic differences in mining costs for U.S. and foreign mines be identified, especially those costs incurred in complying with health, safety, and environmental regulations. Basic costs in extracting raw coal are analyzed in this report for underground longwall mining operations, the only mining method employed in Poland for hard coal. In this report there is also a limited analysis of the relative market competitiveness of selected Polish and U.S. steam and metallurgical coal mines in the European electric utility and metallurgical coal markets

  16. ["TECHNIKA I NAUKA" ["SCIENCE AND TECHNOLOGY"] (1958-)--MAGAZINE OF THE ASSOCIATION OF POLISH ENGINEERS IN GREAT BRITAIN].

    Science.gov (United States)

    Chwastyk-Kowalczyk, Jolanta

    2015-01-01

    This article presents the history of establishment, functioning and the role of "Science and Technology"--quarterly of the Association of Polish Engineers in Great Britain--in shaping Polish technical thought in the environment of Polish engineers and technicians living in exile. The analysis of the content of the journal published in London in the years 1958-2008 made it evident that this official scientific organ of Polish technical intelligentsia edited in 500 copies reaches members of engineering, technical and scientific milieu across many continents. Despite the fact that Polish language dominates in the articles and thanks to the interdisciplinary character of their content - science and technology, biology, the humanities, sociology and others--the journal makes it possible for the reader to participate in an intellectual adventure. "Science and Technology" was created in 1958 on the initiative of Eng. Prof. Roman Wajda in Great Britain, with support of other Polish technical associations abroad, and embraced the achievements and organisational life of the Polish technical milieu dispersed around the world. On the basis of the London Society's archive materials and old annual volumes of the journal, the author listed editors-in-chief, composition of editorial committees, collaborators, determined editing costs, changeable periodicity, successive print shops, seats of editorial office that always followed the Association in Great Britain. She also showed the effort of a handful of members of editorial committees, working on a voluntary basis to obtain materials for the journal; the role of the journal linking Polish engineers and technicians in exile and its function as a link with the Country, as well as its role in the sphere of information and propaganda. Finally, the author made an analysis of the journal's content, focusing on categories of articles published in "Science and Technology" in the years 1958-2008. Methods used by the author in the article

  17. Research ethics in physical education

    Directory of Open Access Journals (Sweden)

    Júlio César Schmitt Rocha

    2009-06-01

    Full Text Available The objective here is to point out ethics in Physical Education research against a backdrop of individual and collective human conduct. Since Plato, the question of ethics in the Western world has been an incessant search for the virtues to harmonize personal and social wellbeing and for the absolute principles of conduct: Autonomy, Beneficence and Justice. Physical Education cannot exempt itself from these and its countless areas of research. In addition to the moral education that develops and solidifies within social groups, the characteristic of which is action on an individual level, we must also consider ethical principles such as those defended by the Physical Education World Manifesto and those that regulate the professional activities of Physical Education professionals. Irrespective of the area investigated, Research in Physical Education will always clash with institutionalized ethical principles enforced by ethics committees, councils and the values accepted by the researchers. Committees strive to preserve the integrity and dignity of the people enrolled on research studies while the researchers challenge the limits of knowledge at an uncomfortable frontier between the acceptable and the unacceptable within a given context of academic vision and needs.

  18. Perceptions of and Attitudes towards Regional Varieties of Polish: Views from Two Polish Provinces

    Science.gov (United States)

    Milobog, Magdalena; Garrett, Peter

    2011-01-01

    This paper reports a study of perceptions and attitudes relating to regional varieties of Polish. The methodology followed folk linguistic approaches to attitudes research. Respondents in two Polish provinces were asked to draw on a map of Poland where they thought the main regional varieties of Polish were spoken, and then to name and…

  19. Ethical considerations

    International Nuclear Information System (INIS)

    Knoppers, B.M.

    1996-01-01

    Some ethical questions about molecular biology and human radiation studies are raised. The questions relate to the following: genetic epidemiology leading to possible stigmatization of certain groups; protection of medical information, including samples, and respect for privacy; effect of genetic characterization on standards and procedures relating to occupational exposure; exclusion of vulnerable groups from research studies. On the positive side, there is increased funding within Canada for studies of ethical, legal and social issues, and internationally ethical standards are being developed

  20. Evidence and Ethics (Editorial

    Directory of Open Access Journals (Sweden)

    Alison Brettle

    2012-12-01

    Full Text Available Welcome to the December issue of EBLIP, the final issue of my first year as Editor-in-Chief. A year which I have thoroughly enjoyed and one where the fears over what to write in my editorials haven’t materialised. This quarter, ethics has featured quite heavily in my working life so I decided to make this the topic of the editorial, sharing some of my thoughts regarding evidence, ethics and how ethical principles are implemented within the EBLIP journal.Ethics are “principles of conduct or standards of behaviour governing an individual or profession” (Library and Information Science Editorial Committee, 2010, and as individuals or professionals we may be governed by various ethical codes. As I'm sure you know, EBLIP originated in the health domain, where ethical values and ethical research feature strongly. Indeed, by its formal definition, research cannot take place unless “ethical approval” from an appropriate committee has been granted. The practicalities of taking research through the ethical approval process can often be time consuming, and those involved in research need to bear this in mind when planning a project. Each committee will have a slightly different form and process (which can add to the frustration of the researcher, but basically will make their decision to approve on the basis that the research includes obtaining informed consent from participants (i.e., participants know what the research is about and what their involvement will mean; that the research will not cause harm to participants; that confidentiality will be maintained; and that the research undertaken is methodologically rigorous and worthwhile. Preparing a proposal for ethical approval, whilst time consuming, makes the researcher think about all aspects of the research and how it is going to be operationalized, which can save lots of time and effort in the long run and may well also improve the research design. These principles are the same whatever

  1. Medical ethics and ethical dilemmas.

    Science.gov (United States)

    Iyalomhe, G B S

    2009-01-01

    Ethical problems routinely arise in the hospital and outpatient practice settings and times of dilemma do occur such that practitioners and patients are at cross-roads where choice and decision making become difficult in terms of ethics. This paper attempts a synopsis of the basic principles of medical ethics, identifies some ethical dilemmas that doctors often encounter and discusses some strategies to address them as well as emphasizes the need for enhanced ethics education both for physicians and patients particularly in Nigeria. Literature and computer programmes (Medline and PsychoInfo databases) were searched for relevant information. The search showed that the fundamental principles suggested by ethicists to assist doctors to evaluate the ethics of a situation while making a decision include respect for autonomy, beneficence, non-maleficence and justice. Although the above principles do not give answers as to how to handle a particular situation, they serve as a guide to doctors on what principles ought to apply to actual circumstances. The principles sometimes conflict with each other leading to ethical dilemmas when applied to issues such as abortion, contraception, euthanasia, professional misconduct, confidentiality truth telling, professional relationship with relatives, religion, traditional medicine and business concerns. Resolution of dilemmas demand the best of the doctor's knowledge of relevant laws and ethics, his training and experience, his religious conviction and moral principles as well as his readiness to benefit from ethics consultation and the advice of his colleagues. Ethics education should begin from the impressionable age in homes, continued in the medical schools and after graduation to ensure that doctors develop good ethical practices and acquire the ability to effectively handle ethical dilemmas. Also, education of patients and sanction of unethical behaviour will reduce ethical dilemmas.

  2. Contemporary medical ethics: an overview from Iran.

    Science.gov (United States)

    Larijani, Bagher; Zahedi, Farzaneh

    2008-12-01

    The growing potential of biomedical technologies has increasingly been associated with discussions surrounding the ethical aspects of the new technologies in different societies. Advances in genetics, stem cell research and organ transplantation are some of the medical issues that have raised important ethical and social issues. Special attention has been paid towards moral ethics in Islam and medical and religious professions in Iran have voiced the requirement for an emphasis on ethics. In the last decade, great strides have been made in biomedical ethics, especially in the field of education, research and legislation. In this article, contemporary medical ethics in Iran, and the related moral philosophy, have been reviewed in brief and we have discussed some of the activities in the field of medical ethics that have been carried out in our country within recent years. These activities have included the establishment of the National and Regional Committees for Medical Research Ethics and the production of national codes of ethics in biomedical research in the 1990 s and the introduction of a comprehensive strategic plan for medical ethics at the national level in 2002. This paper will discuss these issues, along with the production, in 2005, of the Specific National Ethical Guidelines for Biomedical Research.

  3. History of Polish gastrointestinal radiology.

    Science.gov (United States)

    Urbanik, A

    2003-12-01

    As early as several days after the publication of the information concerning Roentgen's discovery the first radiological examinations were performed in Poland. The new method was immediately introduced into medical practice, including gastroenterology. In that pioneer period the most important works were those by Walery Jaworski who was the first man in the world to perform an X-ray of gall stones as well as the stomach with the use of a contrast medium. In its more-than-a-hundred-year history Polish gastrointestinal radiology has attempted not only to catch up with the world science, but it also has made a considerable contribution to its development.

  4. Corporate Politics on Polish Millennials

    OpenAIRE

    Natalia Roślik

    2017-01-01

    In the very beginning of this particular paper, an author is trying to determine and describe who Millennials actually are. Then, the basis of Millennials definition is analysing corporation’s activity over the past years regarding this age group. The main goal of the thesis is to bring their specific futures out and describe what corporations on Polish job market are doing to encourage them to work in their offices. Especially in Poland within the last years, it is observed that big multinat...

  5. Polish Foundation for Energy Efficiency

    Energy Technology Data Exchange (ETDEWEB)

    NONE

    1995-12-31

    The Polish Foundation for Energy Efficiency (FEWE) was established in Poland at the end of 1990. FEWE, as an independent and non-profit organization, has the following objectives: to strive towards an energy efficient national economy, and to show the way and methods by use of which energy efficiency can be increased. The activity of the Foundation covers the entire territory of Poland through three regional centers: in Warsaw, Katowice and Cracow. FEWE employs well-known and experienced specialists within thermal and power engineering, civil engineering, economy and applied sciences. The organizer of the Foundation has been Battelle Memorial Institute - Pacific Northwest Laboratories from the USA.

  6. Hazy Boundaries: Virtual Communities and Research Ethics

    Directory of Open Access Journals (Sweden)

    Helena Kantanen

    2016-10-01

    Full Text Available This paper examines ethical issues specific to research into virtual communities. Drawing on an empirical case with online forums of education experts, we identify the following key issues: publicity versus privacy of the community; the definition of human subjects research; participant recruitment; informed consent; and ethical questions associated with observing virtual communities, and with reporting and disseminating research results. We maintain that different research cultures in different countries can present challenges when studying global forums. Acknowledging the ephemeral characteristics of Internet contexts, this paper argues that ethical considerations should be more case-based, instead of relying on one model for all solutions. We suggest that local ethics committees or institutional review boards could, with their expert knowledge of ethics, provide valuable support for researchers operating in the complex and dynamic terrain of Internet research, as well as in fields and research settings where an ethical review is not a standard part of the research process.

  7. Sexual activity of Polish adults.

    Science.gov (United States)

    Pastwa-Wojciechowska, Beata; Izdebski, Zbigniew

    2014-01-01

    The purpose of this research was to explore the subject of sexual activity in the Polish population, with special focus on age and gender differences, and sexual infidelity. Sexual activity is one of the basic factors in initiating and maintaining relationships. On the one hand, sexual activity enables us to meet natural needs and maintain an intimate relationship with another human being; on the other, it may allow us to overcome loneliness and social isolation by providing the opportunity to express feelings of closeness and unity. The research was conducted on a representative group of 3,200 Poles aged between 15-49, with the support of a well-known Polish research company - TNS OBOP. Face-to-face and Pencil and Paper (PAPI) interviews were carried out. The results focus on two main issues: the age and motives of sexual initiation among teenagers (with a significant percentage starting their sexual activity at the age of 15), and the quality of the sexual lives of adults (average number of sexual partners, sexual infidelity and sexual satisfaction). There is dependence between the type of relationship and the performance or non-performance of sexual activity, as well as the quality of the relationship. Among both adolescents and adults, remaining in a stable relationship (partnership or marriage) promotes loyalty. The performance of sexual goals turns out to be an important mechanism regulating the interpersonal aspects of a relationship, influencing their perception and evaluation.

  8. Sexual activity of Polish adults

    Directory of Open Access Journals (Sweden)

    Beata Pastwa-Wojciechowska

    2014-03-01

    Full Text Available Aim. The purpose of this research was to explore the subject of sexual activity in the Polish population, with special focus on age and gender differences, and sexual infidelity. Sexual activity is one of the basic factors in initiating and maintaining relationships. On the one hand, sexual activity enables us to meet natural needs and maintain an intimate relationship with another human being; on the other, it may allow us to overcome loneliness and social isolation by providing the opportunity to express feelings of closeness and unity. Material and method. The research was conducted on a representative group of 3,200 Poles aged between 15–49, with the support of a well-known Polish research company – TNS OBOP. Face-to-face and Pencil and Paper (PAPI interviews were carried out. Results. The results focus on two main issues: the age and motives of sexual initiation among teenagers (with a significant percentage starting their sexual activity at the age of 15, and the quality of the sexual lives of adults (average number of sexual partners, sexual infidelity and sexual satisfaction. Conclusion. There is dependence between the type of relationship and the performance or non-performance of sexual activity, as well as the quality of the relationship. Among both adolescents and adults, remaining in a stable relationship (partnership or marriage promotes loyalty. The performance of sexual goals turns out to be an important mechanism regulating the interpersonal aspects of a relationship, influencing their perception and evaluation.

  9. Buffered Electrochemical Polishing of Niobium

    Energy Technology Data Exchange (ETDEWEB)

    Ciovati, Gianluigi [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States); Tian, Hui [Thomas Jefferson National Accelerator Facility (TJNAF), Newport News, VA (United States); College of William and Mary, Williamsburg, VA (United States); Corcoran, Sean [Virginia Polytechnic Inst. and State Univ. (Virginia Tech), Blacksburg, VA (United States)

    2011-03-01

    The standard preparation of superconducting radio-frequency (SRF) cavities made of pure niobium include the removal of a 'damaged' surface layer, by buffered chemical polishing (BCP) or electropolishing (EP), after the cavities are formed. The performance of the cavities is characterized by a sharp degradation of the quality factor when the surface magnetic field exceeds about 90 mT, a phenomenon referred to as 'Q-drop.' In cavities made of polycrystalline fine grain (ASTM 5) niobium, the Q-drop can be significantly reduced by a low-temperature (? 120 °C) 'in-situ' baking of the cavity if the chemical treatment was EP rather than BCP. As part of the effort to understand this phenomenon, we investigated the effect of introducing a polarization potential during buffered chemical polishing, creating a process which is between the standard BCP and EP. While preliminary results on the application of this process to Nb cavities have been previously reported, in this contribution we focus on the characterization of this novel electrochemical process by measuring polarization curves, etching rates, surface finish, electrochemical impedance and the effects of temperature and electrolyte composition. In particular, it is shown that the anodic potential of Nb during BCP reduces the etching rate and improves the surface finish.

  10. Ethics in action: Approving and improving medical research with human subjects

    OpenAIRE

    de Jong, J.P.

    2013-01-01

    In this thesis, Jean Philippe de Jong presents a new understanding of ethical oversight on medical research with human subjects and proposes that two philosophies for ethical oversight exist: '(dis)approving' and 'improving'. Systems for ethical oversight on medical research have been in place for many years, with Research Ethics Committees as their cornerstone. Although these oversight systems aim to ensure that the ethical quality of research is in order, they have been criticized for imped...

  11. Method of polishing nickel-base alloys and stainless steels

    Science.gov (United States)

    Steeves, Arthur F.; Buono, Donald P.

    1981-01-01

    A chemical attack polish and polishing procedure for use on metal surfaces such as nickel base alloys and stainless steels. The chemical attack polish comprises Fe(NO.sub.3).sub.3, concentrated CH.sub.3 COOH, concentrated H.sub.2 SO.sub.4 and H.sub.2 O. The polishing procedure includes saturating a polishing cloth with the chemical attack polish and submicron abrasive particles and buffing the metal surface.

  12. Ethics education in psychoanalytic training: a survey.

    Science.gov (United States)

    Ransohoff, Paul M

    2010-02-01

    Didactic education in psychoanalytic ethics is a relatively new phenomenon. Ethics courses were offered by few institutes before they were mandated and before publication of the first Ethics Case Book in 2001. As institutes have developed ethics training, the solutions they have arrived at-formats, length and placement of courses, and preferred readings- remain unknown to other educators and analysts. This survey was undertaken to gain an overview of the current state of ethics education. Twenty-nine of the thirty-one training institutes of the American Psychoanalytic Association (93%) responded to inquiries. Most institutes (79%) offered one course, and the average number of class sessions was 6.3. Of 258 different readings used, 61 (23.6%) were used by more than one institute and 37 (14.3%) by more than two. The most frequent topics were boundaries, confidentiality, and illness, and Dewald and Clark's Case Book (2008) and Gabbard and Lester (1995) were the most common readings. These findings should be useful to instructors, curriculum committees, and ethics committees in their ethics education planning, as well as to practicing analysts in their ethical self-education. This study may also serve as a model for analogous investigations into other areas of analytic education and as an impetus to further research and educational innovation.

  13. 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…

  14. Virtue ethics.

    OpenAIRE

    Vernon, Gervase

    2003-01-01

    The Handbook of Economics and Ethics portrays an understanding of economic methodology in which facts and values, though distinct, are closely interconnected in a variety of ways. From theory building to data collection, and from modelling to policy evaluation, this encyclopaedic Handbook is at the intersection of economics and ethics.

  15. Large ethics.

    Science.gov (United States)

    Chambers, David W

    2008-01-01

    This essay presents an alternative to the traditional view that ethics means judging individual behavior against standards of right and wrong. Instead, ethics is understood as creating ethical communities through the promises we make to each other. The "aim" of ethics is to demonstrate in our own behavior a credible willingness to work to create a mutually better world. The "game" of ethics then becomes searching for strategies that overlap with others' strategies so that we are all better for intending to act on a basis of reciprocal trust. This is a difficult process because we have partial, simultaneous, shifting, and inconsistent views of the world. But despite the reality that we each "frame" ethics in personal terms, it is still possible to create sufficient common understanding to prosper together. Large ethics does not make it a prerequisite for moral behavior that everyone adheres to a universally agreed set of ethical principles; all that is necessary is sufficient overlap in commitment to searching for better alternatives.

  16. BUSINESS ETHICS

    Directory of Open Access Journals (Sweden)

    Nelu BURCEA

    2014-12-01

    Full Text Available Through this study we seek to explore the concept of business ethics, in those aspects that we consider to be essential and concrete. We started from a few questions: Could the two concepts be compatible? If not, why not? If yes, could they be complementary? How real is the use of ethics in the profits of a business? How can be business ethics be exemplified and what principles are essential in doing business? How does the business environment react to the concept? These are some of the elements that will form the basis of this scientific study. Lately, business ethics has been becoming an increasingly popular topic. Set against the global economic crisis, the companies’ credibility could become a major concern. Business ethics also becomes a challenge for training and informing employees and employers, in order to make not only economical, but also ethical decisions regarding their profits. In the study we shall also address the ethical standards required in a business world interested in fundamental values that can make the difference in 21st century business. Also, according to a study conducted by the authors, we shall address the two most important ethical values that prove to be essential to a business.

  17. Advanced techniques for computer-controlled polishing

    Science.gov (United States)

    Schinhaerl, Markus; Stamp, Richard; Pitschke, Elmar; Rascher, Rolf; Smith, Lyndon; Smith, Gordon; Geiss, Andreas; Sperber, Peter

    2008-08-01

    Computer-controlled polishing has introduced determinism into the finishing of high-quality surfaces, for example those used as optical interfaces. Computer-controlled polishing may overcome many of the disadvantages of traditional polishing techniques. The polishing procedure is computed in terms of the surface error-profile and the material removal characteristic of the polishing tool, the influence function. Determinism and predictability not only enable more economical manufacture but also facilitate considerably increased processing accuracy. However, there are several disadvantages that serve to limit the capabilities of computer-controlled polishing, many of these are considered to be issues associated with determination of the influence function. Magnetorheological finishing has been investigated and various new techniques and approaches that dramatically enhance the potential as well as the economics of computer-controlled polishing have been developed and verified experimentally. Recent developments and advancements in computer-controlled polishing are discussed. The generic results of this research may be used in a wide variety of alternative applications in which controlled material removal is employed to achieve a desired surface specification, ranging from surface treatment processes in technical disciplines, to manipulation of biological surface textures in medical technologies.

  18. Intelligence Ethics:

    DEFF Research Database (Denmark)

    Rønn, Kira Vrist

    2016-01-01

    .e., the search for an ideal ethical framework for intelligence actions). The article concludes that there are many holes to fill for future studies on intelligence ethics both in external and internal discussions. Thus, the article is an invitation – especially, to moral philosophers and political theorists......Questions concerning what constitutes a morally justified conduct of intelligence activities have received increased attention in recent decades. However, intelligence ethics is not yet homogeneous or embedded as a solid research field. The aim of this article is to sketch the state of the art...... of intelligence ethics and point out subjects for further scrutiny in future research. The review clusters the literature on intelligence ethics into two groups: respectively, contributions on external topics (i.e., the accountability of and the public trust in intelligence agencies) and internal topics (i...

  19. Evaluation of clinical trials by Ethics Committees in Germany – results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa

    Directory of Open Access Journals (Sweden)

    Russ, Hagen

    2015-01-01

    Full Text Available [english] Objective: The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP ordinance (German: GCP-Verordnung, GCP-V, the quality of evaluations of those applications by Ethics Committees (ECs/Investigational Review Boards (IRBs in Germany as well as the pattern of EC objections in their reasoned opinions (vote. In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008.Methods: Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared.Results: Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18 took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I–IV clinical trials submitted to the regulatory authorities (BfArM and PEI in 2011.In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007 was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007. The amount of objections increased by 21% from 1,299 (2007 to 1,574 (2011 resulting in an average of 4.5 (2007 vs. 6.3 (2011 objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent

  20. Evaluation of clinical trials by Ethics Committees in Germany--results and a comparison of two surveys performed among members of the German Association of Research-Based Pharmaceutical Companies (vfa).

    Science.gov (United States)

    Russ, Hagen; Busta, Susanne; Jost, Bertfried; Bethke, Thomas D

    2015-01-01

    The objective of this project was to evaluate the quality and quantity of initial applications for a clinical trial according to § 7 of the German Good Clinical Practice (GCP) ordinance (German: GCP-Verordnung, GCP-V), the quality of evaluations of those applications by Ethics Committees (ECs)/Investigational Review Boards (IRBs) in Germany as well as the pattern of EC objections in their reasoned opinions (vote). In order to identify a change over time, the results of the present survey were also compared with a survey performed in 2008. Based on reasoned opinions issued by the respective EC in charge of the coordinating principle investigator (coordinating EC) in 2011, a written survey among members of the German Association of Research-Based Pharmaceutical Companies (vfa) was conducted in 2012. The answers to the questionnaire were analyzed descriptively. Since the data set collected in 2011 was structurally identical with the data set gained in 2007 both surveys were compared. Of the 24 companies represented on the vfa Clinical Research/Quality Assurance Subcommittee, 75% (18) took part in the survey. Survey evaluation was based on a total of 251 applications of these 18 companies submitted to 43 ECs. These account for about 21% of 1,214 applications for authorization of commercial and non-commercial phase I-IV clinical trials submitted to the regulatory authorities (BfArM and PEI) in 2011. In comparison to 2007, a lower amount of applications (n=251 in 2011 vs. n=288 in 2007) was submitted to a slightly higher number of ECs (43 in 2011 vs. 40 in 2007). The amount of objections increased by 21% from 1,299 (2007) to 1,574 (2011) resulting in an average of 4.5 (2007) vs. 6.3 (2011) objections per application. Overall, the analysis of both formal and content related objections revealed almost the same pattern as in the previous survey. In total, the most frequent objections applied to the patient information and consent form followed in descending order by trial

  1. Research Ethics Consultation: Ethical and Professional Practice Challenges and Recommendations

    Science.gov (United States)

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

    2015-01-01

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

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

    Science.gov (United States)

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

    2015-05-01

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

  3. Ethics in clinical research: the Indian perspective.

    Science.gov (United States)

    Sanmukhani, J; Tripathi, C B

    2011-03-01

    Ethics in clinical research focuses largely on identifying and implementing the acceptable conditions for exposure of some individuals to risks and burdens for the benefit of society at large. Ethical guidelines for clinical research were formulated only after discovery of inhumane behaviour with participants during research experiments. The Nuremberg Code was the first international code laying ethical principles for clinical research. With increasing research all over, World Health Organization formulated guidelines in the form of Declaration of Helsinki in 1964. The US laid down its guidelines for ethical principles in the Belmont Report after discovery of the Tuskegee's Syphilis study. The Indian Council of Medical Research has laid down the 'Ethical Guidelines for Biomedical Research on Human Subjects' in the year 2000 which were revised in 2006. It gives twelve general principles to be followed by all biomedical researchers working in the country. The Ethics Committee stands as the bridge between the researcher and the ethical guidelines of the country. The basic responsibility of the Ethics Committee is to ensure an independent, competent and timely review of all ethical aspects of the project proposals received in order to safeguard the dignity, rights, safety and well-being of all actual or potential research participants. A well-documented informed consent process is the hallmark of any ethical research work. Informed consent respects individual's autonomy, to participate or not to participate in research. Concepts of vulnerable populations, therapeutic misconception and post trial access hold special importance in ethical conduct of research, especially in developing countries like India, where most of the research participants are uneducated and economically backward.

  4. Corporate Politics on Polish Millennials

    Directory of Open Access Journals (Sweden)

    Natalia Roślik

    2017-12-01

    Full Text Available In the very beginning of this particular paper, an author is trying to determine and describe who Millennials actually are. Then, the basis of Millennials definition is analysing corporation’s activity over the past years regarding this age group. The main goal of the thesis is to bring their specific futures out and describe what corporations on Polish job market are doing to encourage them to work in their offices. Especially in Poland within the last years, it is observed that big multinational companies are paying special attention to Millennials and trying to hire them before competitors will do so. As a part of this paper, an author will describe corporate politics and practices on Thomson Reuters and BNY Mellon examples. Within this work, an author is also discussing key features and differences between this generation and Millennials parent’s generation. Additionally, there is a reference to corporate social responsibility concept and work-life balance issues.

  5. BUSINESS ETHICS

    OpenAIRE

    Nelu BURCEA; Ion CROITORU

    2014-01-01

    Through this study we seek to explore the concept of business ethics, in those aspects that we consider to be essential and concrete. We started from a few questions: Could the two concepts be compatible? If not, why not? If yes, could they be complementary? How real is the use of ethics in the profits of a business? How can be business ethics be exemplified and what principles are essential in doing business? How does the business environment react to the concept? These are some of the eleme...

  6. Communicating Qualitative Research Study Designs to Research Ethics Review Boards

    Science.gov (United States)

    Ells, Carolyn

    2011-01-01

    Researchers using qualitative methodologies appear to be particularly prone to having their study designs called into question by research ethics or funding agency review committees. In this paper, the author considers the issue of communicating qualitative research study designs in the context of institutional research ethics review and offers…

  7. Historical Roots and Future Perspectives Related to Nursing Ethics.

    Science.gov (United States)

    Freitas, Lorraine

    1990-01-01

    This article traces the evolution of the development and refinement of the professional code from concerns about the ethical conduct of nurses to its present state as a professional code for all nurses. The relationship of the Ethics Committee of the American Nurses' Association to the development of the code is also discussed. (Author/MLW)

  8. Documentation of ethical considerations in published articles in ...

    African Journals Online (AJOL)

    Introduction. Guidelines for biomedical research involving human subjects require that research should be conducted in accordance with accepted ethical principles. The International Committee of Medical Journal Editors guidelines require authors to indicate that they have obtained ethical approval and informed consent.

  9. Smoking characteristics of Polish immigrants in Dublin

    Directory of Open Access Journals (Sweden)

    Zatonski Witold

    2008-12-01

    Full Text Available Abstract Background This study examined two main hypotheses: a Polish immigrants' smoking estimates are greater than their Irish counterparts (b Polish immigrants purchasing cigarettes from Poland smoke "heavier" (≥ 20 cigarettes a day when compared to those purchasing cigarettes from Ireland. The study also set out to identify significant predictors of 'current' smoking (some days and everyday among the Polish immigrants. Methods Dublin residents of Polish origin (n = 1,545 completed a previously validated Polish questionnaire in response to an advertisement in a local Polish lifestyle magazine over 5 weekends (July–August, 2007. The Office of Tobacco Control telephone-based monthly survey data were analyzed for the Irish population in Dublin for the same period (n = 484. Results Age-sex adjusted smoking estimates were: 47.6% (95% Confidence Interval [CI]: 47.3%; 48.0% among the Poles and 27.8% (95% CI: 27.2%; 28.4% among the general Irish population (p 24 months were significant predictors of current smoking among the Poles. An objective validation of the self-reported smoking history of a randomly selected sub-sample immigrant group, using expired carbon monoxide (CO measurements, showed a highly significant correlation coefficient (r = 0.64 of expired CO levels with the reported number of cigarettes consumed (p Conclusion Polish immigrants' smoking estimates are higher than their Irish counterparts, and particularly if employed, with only primary-level education, and are overseas >2 years.

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

    Science.gov (United States)

    Piasecki, Jan; Waligora, Marcin; Dranseika, Vilius

    2017-06-01

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

  11. Abusing ethics

    DEFF Research Database (Denmark)

    Olivares Bøgeskov, Benjamin Miguel

    This paper presents the result from our research on how nurse managers use and occasionally misuse inconclusive ethical arguments to engage their personnel in current reforms. The Danish health care system has undergone a series of reforms inspired by New Public Management theories, which have......, paying special attention to the way in which ethical arguments are used in relation to engagement. Our research shows that ethical arguments are extremely common, and they are used either to elicit engagement, or to demand engagement considering the result of a duty. However, most interestingly...... it was possible for us to find recurrence of fallacious arguments of different kinds. Based on these findings, I will argue that the use of fallacious arguments in order to generate engagement is in reality an abusive use of ethics, which raises important questions. I argue that depending on the degree...

  12. Transplant Ethics.

    Science.gov (United States)

    Altınörs, Nur; Haberal, Mehmet

    2016-11-01

    The aim of this study was to review and discuss the great variety of ethical issues related to organ donation, organ procurement, transplant activities, and new ethical problems created as a result of technologic and scientific developments. An extensive literature survey was made, and expert opinions were obtained. The gap between demand and supply of organs for transplant has yielded to organ trafficking, organ tourism, and commercialism. This problem seems to be the most important issue, and naturally there are ethical dilemmas related to it. A wide number of ideas have been expressed on the subject, and different solutions have been proposed. The struggle against organ trafficking and commercialism should include legislation, efforts to increase deceased-donor donations, and international cooperation. China's policy to procure organs from prisoners sentenced to death is unethical, and the international community should exert more pressure on the Chinese government to cease this practice. Each particular ethical dilemma should be taken separately and managed.

  13. An overview of the major changes in the 2002 APA Ethics Code.

    Science.gov (United States)

    Knapp, Samuel; VandeCreek, Leon

    2003-06-01

    This article summarizes the major changes that were made to the 2002 Ethical Principles and Code of Conduct of the American Psychological Association. The 2002 Ethics Code retains the general format of the 1992 Ethics Code and does not radically alter the obligations of psychologists. One goal of the Ethics Committee Task Force was to reduce the potential of the Ethics Code to be used to unnecessarily punish psychologists. In addition, the revised Ethics Code expresses greater sensitivity to the needs of cultural and linguistic minorities and students. Shortcomings of the 2002 Ethics Code are discussed.

  14. Ethical dilemmas

    DEFF Research Database (Denmark)

    Aabro, Christian

    2015-01-01

    What are the characteristics of an ethical dilemma? And how do we handle them in the area of early childhood education? These are some of the questions that will be dealt with in this chapter.......What are the characteristics of an ethical dilemma? And how do we handle them in the area of early childhood education? These are some of the questions that will be dealt with in this chapter....

  15. Population Ethics

    OpenAIRE

    BLACKORBY, Charles; BOSSERT, Walter; DONALDSON, David

    2006-01-01

    This paper reviews the welfarist approach to population ethics. We provide an overview of the critical-level utilitarian population principles and their generalized counterparts, examine important properties of these principles and discuss their relationships to other variable-population social-evaluation rules. We illustrate the difficulties arising in population ethics by means of an impossibility result and present characterizations of the critical-level generalized-utilitarian principles ...

  16. Implicit and explicit clinical ethics support in The Netherlands: a mixed methods overview study

    NARCIS (Netherlands)

    Dauwerse, L.; Weidema, F.C.; Abma, T.; Molewijk, A.C.; Widdershoven, G.

    2014-01-01

    Internationally, the prevalence of clinical ethics support (CES) in health care has increased over the years. Previous research on CES focused primarily on ethics committees and ethics consultation, mostly within the context of hospital care. The purpose of this article is to investigate the

  17. Super-polishing of Zerodur aspheres by means of conventional polishing technology

    Science.gov (United States)

    Polak, Jaroslav; Klepetková, Eva; Pošmourný, Josef; Šulc, Miroslav; Procháska, František; Tomka, David; Matoušek, Ondřej; Poláková, Ivana; Šubert, Eduard

    2015-01-01

    This paper describes a quest to find simple technique to superpolish Zerodur asphere (55μm departure from best fit sphere) that could be employed on old fashion way 1-excenter optical polishing machine. The work focuses on selection of polishing technology, study of different polishing slurries and optimization of polishing setup. It is demonstrated that either by use of fine colloidal CeO2 slurry or by use of bowl-feed polishing setup with CeO2 charged pitch we could reach 0.4nm RMS roughness while removing <30nm of surface layer. This technique, although not optimized, was successfully used to improve surface roughness on already prepolished Zerodur aspheres without necessity to involve sophisticated super-polishing technology and highly trained manpower.

  18. Comparative study of performance of shoe polishes formulated from ...

    African Journals Online (AJOL)

    GARZALI

    This should make the polish remains as discrete solid particles held mechanically within the leather. This work intends to explore the use of polyethylene pigment in the production of shoe polish. The shoe polish produced will be applied alongside shoe polish from carbon black (CI black Pigment 7) on finished black leather ...

  19. Written institutional ethics policies on euthanasia: an empirical-based organizational-ethical framework.

    Science.gov (United States)

    Lemiengre, Joke; Dierckx de Casterlé, Bernadette; Schotsmans, Paul; Gastmans, Chris

    2014-05-01

    As euthanasia has become a widely debated issue in many Western countries, hospitals and nursing homes especially are increasingly being confronted with this ethically sensitive societal issue. The focus of this paper is how healthcare institutions can deal with euthanasia requests on an organizational level by means of a written institutional ethics policy. The general aim is to make a critical analysis whether these policies can be considered as organizational-ethical instruments that support healthcare institutions to take their institutional responsibility for dealing with euthanasia requests. By means of an interpretative analysis, we conducted a process of reinterpretation of results of former Belgian empirical studies on written institutional ethics policies on euthanasia in dialogue with the existing international literature. The study findings revealed that legal regulations, ethical and care-oriented aspects strongly affected the development, the content, and the impact of written institutional ethics policies on euthanasia. Hence, these three cornerstones-law, care and ethics-constituted the basis for the empirical-based organizational-ethical framework for written institutional ethics policies on euthanasia that is presented in this paper. However, having a euthanasia policy does not automatically lead to more legal transparency, or to a more professional and ethical care practice. The study findings suggest that the development and implementation of an ethics policy on euthanasia as an organizational-ethical instrument should be considered as a dynamic process. Administrators and ethics committees must take responsibility to actively create an ethical climate supporting care providers who have to deal with ethical dilemmas in their practice.

  20. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review.

    Science.gov (United States)

    Farajkhoda, Tahmineh

    2017-02-01

    Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs) research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies), appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights) in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening legislation systems

  1. An overview on ethical considerations in stem cell research in Iran and ethical recommendations: A review

    Directory of Open Access Journals (Sweden)

    Tahmineh Farajkhoda

    2017-08-01

    Full Text Available Conducting research on the stem cell lines might bring some worthy good to public. Human Stem Cells (hSCs research has provided opportunities for scientific progresses and new therapies, but some complex ethical matters should be noticed to ensure that stem cell research is carried out in an ethically appropriate manner. The aim of this review article is to discuss the importance of stem cell research, code of ethics for stem cell research in Iran and ethical recommendation. Generation of stem cells for research from human embryo or adult stem cells, saving, maintenance and using of them are the main ethical, legal and jurisprudence concerns in Iran. Concerns regarding human reproduction or human cloning, breach of human dignity, genetic manipulation and probability of tumorogenisity are observed in adult/somatic stem cells. Destruction of embryo to generate stem cell is an important matter in Iran. In this regards, obtaining stem cell from donated frozen embryos through infertility treatment that would be discarded is an acceptable solution in Iran for generation of embryo for research. Ethical, legal, and jurisprudence strategies for using adult/somatic stem cells are determination of ownership of stem cells, trade prohibition of human body, supervision on bio banks and information of Oversight Committee on Stem Cell Research. Recommendations to handle ethical issues for conducting stem cell research are well-designed studies, compliance codes of ethics in biomedical research (specifically codes of ethics on stem cell research, codes of ethics on clinical trials studies and codes of ethics on animals studies, appropriate collaboration with ethics committees and respecting of rights of participants (including both of human and animal rights in research. In addition, there is a necessity for extending global networks of bioethics for strengthening communications within organizations at both the regional and international level, strengthening

  2. Comités de ética independientes para la investigación clínica en la Argentina: Evaluación y sistema para garantizar su independencia Independent ethics committees for clinical research in Argentina: An evaluation and a system to guarantee their independence

    Directory of Open Access Journals (Sweden)

    Sergio E. Gonorazky

    2008-04-01

    Full Text Available La Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT exige para la ejecución de protocolos de investigación de nuevos fármacos en seres humanos, que éstos sean previamente evaluados y aprobados por un denominado comité de ética independiente de los patrocinadores e investigadores. Sin embargo, esta evaluación es lucrativa y la elección del comité de ética independiente es realizada por el patrocinador y/o investigador, lo que convierte la supuesta independencia en una relación del tipo "prestador de servicio - cliente". El Consejo de Revisión Institucional de Estudios de Investigación del Hospital Privado de Comunidad de Mar del Plata evaluó, entre los años 2005 y 2006, treinta y tres protocolos (con sus correspondientes hojas de información al paciente y consentimientos informados aprobados previamente por un comité de ética independiente no institucional. La mediana de objeciones relevantes realizadas por este Consejo de Revisión a los mencionados protocolos, que obligaron a que sean modificados para luego ser aprobados, fue de tres por protocolo. La acreditación de los Comités de Ética Independiente exige un sistema que garantice la real independencia de éstos de los patrocinadores y/o investigadores a la vez que mecanismos de control de gestión que incluyan una eventual pérdida de la acreditación. Este trabajo propone algunas medidas concretas para corregir las deficiencias del sistema actual.The Administración Nacional de Medicamentos, Alimentos y Tecnología Médica de la República Argentina (ANMAT requires that an independent ethics committee of sponsors and/or researchers must previously evaluate and approve all the new pharmacological research protocols carried out on human beings. However, due to the lucrative nature of the evaluation, and because the selection of the Independent Ethics Committee is carried out by the sponsors and/or researchers, the

  3. New Environmental Practices in Polish Production Firms

    DEFF Research Database (Denmark)

    Kræmer, Trine Pipi

    2002-01-01

    Based on five case studies in Poland, the paper discusses, how a specific environmental policy influences the firms? industrial environmental practices. The study illustrates, how the Polish environmental policy, dominated by environmental charges on emissions, is extremely effective in improving...

  4. Electro Polishing of Niobium Cavities at DESY

    CERN Document Server

    Matheisen, A; Morales, H; Petersen, B; Schmoekel, M; Steinhau-Kühl, N

    2004-01-01

    At DESY a facility for electro polishing (EP) of the super conducting (s.c.) TESLA/TTF cavities have been built and is operational since summer 2003. The EP infrastructure is capable to handle single-cell structures and the standard TESLA/ TTF nine-cell cavities. Several electro polishing processes have been made since and acceleration voltage up to 40 MV/m have been reached in nine cell structures. We report on measurements and experiences gained since 2003 as well as on handling procedures developed for the preparation of electro polished resonators. Specific data like heat production, variation of current density and bath aging will be presented. Another important point for reproducible results is the quality control of the electro polishing process. First quality control steps to be implanted in the EP procedure for large-scale production will be described.

  5. Semiological analysis of Polish theater posters

    Directory of Open Access Journals (Sweden)

    Jelena Nikolić

    2016-02-01

    Full Text Available Through the application of semiological analysis to theater posters made by two Polish authors, the paper uncovers signs, meanings, codes and specifics of the „Polish school of poster-making“ and contemporary Polish posters. Aside from this, I suggest a methodological framework for studying the issue of coding and shaping a theater poster as a culturally specific form of visual communication. The aesthetic and semiotic outlook of the Polish theater posters which were chosen is analyzed using the semiological method which highlights their differences and similarities. By pointing out the system of codes through the examples given here, a graphic designer is informed about the existence and the possibilities of a more systematic approach to shaping a theater poster.

  6. Report on Polish Public Libraries 2001

    OpenAIRE

    Bednarek-Michalska, Bożena; Szatkowska, Olga

    2001-01-01

    Report is an overview of polish public libraries, services to a variety of communities, it also provides statistics, n explanation of the funding policy for public libraries in Poland and information about the governance of public libraries in the country.

  7. Assessing the animal ethics review process

    DEFF Research Database (Denmark)

    Varga, O.; Sandøe, Peter; Olsson, I.A.S.

    2012-01-01

    on ensuring that the animals are caused a minimum of harm relative to the possibility of achieving beneficial results. Even though rules in this area are reasonably uniform there seems to be significant room for differences, individual and culturally based, between ethics committees concerning how the rules...

  8. Authorship Ethics. ERIC/AE Digest.

    Science.gov (United States)

    Syrett, Kristen L.; Rudner, Lawrence M.

    The key ethical standards for authorship of educational research are summarized, drawing on "Uniform Requirements for Manuscripts Submitted to Biomedical Journals" developed by the International Committee of Medical Journal Editors. Adopted by more than 500 scientific and biomedical journals, these standards are effective guidelines for…

  9. Ethical Issues in Collaborative Action Research

    Science.gov (United States)

    Locke, Terry; Alcorn, Noeline; O'Neill, John

    2013-01-01

    This article begins by raising issues around the way in which ethical approval for research is managed in university settings, where committees often base their assumptions on a principlist approach making a number of assumptions that we consider to be contestable, such as a neat separation between researcher and researched. However, collaborative…

  10. Architecture towards a new ethical challenge

    Directory of Open Access Journals (Sweden)

    Joseph Rykwert

    2015-11-01

    Full Text Available The most Pressing Challenge to any architect seems to me the ethical one. Always to see the client as a person,as an interlocutor however anonymous they may seem, however committee-like the commissioning process — and to see their work as a dialogue with the client.

  11. Architecture towards a new ethical challenge

    OpenAIRE

    Joseph Rykwert

    2015-01-01

    The most Pressing Challenge to any architect seems to me the ethical one. Always to see the client as a person,as an interlocutor however anonymous they may seem, however committee-like the commissioning process — and to see their work as a dialogue with the client.

  12. Ecological Ethics

    International Nuclear Information System (INIS)

    Oughton, Deborah

    2013-01-01

    Deborah Oughton started with a view of the work in progress by the ICRP TG 94 on ethics, from the historical context and the principles-based ethics in RP, to continue with an overview of the ethical theories and with the main area of elaboration which concerns the common values, to conclude with considerations about the implementation in different area such as biomedicine, nuclear safety and workers, ecological aspects, and environmental health and society. By reading again the ICRP and IAEA publications on the ethical aspects in the protection of environment from the effects of ionizing radiation, the presentation covers the various and different cultures within the history of environmental ethics, the perception of Nature and the theories of environmental ethics, in particular by focusing on anthropocentrism, biocentrism and ecocentrism, as philosophical worldwide views, and on conservation, biodiversity, sustainability, environmental justice and human dignity, as primary principles of environmental protection. The influence of western Christianity, with a view of man dominating over every creeping thing on earth, and of the non-western ideas, the human perception of Nature has been analyzed and discussed to conclude that, in reality then, the anthropocentrism, biocentrism and ecocentrism, as reflected in many cultures and religions, they all support the need to protect the environment and to recognise and preserve the diversity. Three challenges were then discussed in the presentation: the ecosystem approach and ecological economics, for example in the case of Fukushima by asking what is the economic cost of marine contamination; the ecosystem changes with attention to what harms, as in the case of the environment in the contaminated areas around Chernobyl; and the environmental consequences of remediation, which can be considered a source of controversy for environmental ethics and policy

  13. Electrolytic polishing system for space age materials

    International Nuclear Information System (INIS)

    Coons, W.C.; Iosty, L.R.

    1976-01-01

    A simple electrolytic polishing technique was developed for preparing Cr, Co, Hf, Mo, Ni, Re, Ti, V, Zr, and their alloys for structural analysis on the optical microscope. The base electrolyte contains 5g ZnCl 2 and 15g AlCl 3 . 6H 2 O in 200 ml methyl alcohol, plus an amount of H 2 SO 4 depending on the metal being polished. Five etchants are listed

  14. Trace element analysis of nail polishes

    International Nuclear Information System (INIS)

    Misra, G.; Mittal, V.K.; Sahota, H.S.

    1999-01-01

    Instrumental neutron activation analysis (INAA) technique was used to measure the concentrations of various trace elements in nail polishes of popular Indian and foreign brands. The aim of the present experiment was to see whether trace elements could distinguish nail polishes of different Indian and foreign brands from forensic point of view. It was found that cesium can act as a marker to differentiate foreign and Indian brands. (author)

  15. Interlocking directorships in Polish joint stock companies:

    OpenAIRE

    Pawlak, Marek

    2008-01-01

    Studies concerning interlocking directorships have been carried out among Polish joint stock corporations. The main source of data have been the announcements that are to be published by corporations regularly in a journal called Business and Court Gazette (BCG). Interlocking directorships constitute a network among corporations the use of which enables co-ordinated management of the whole group. The phenomenon of interlocking directorships in Polish joint stock companies can be compared to t...

  16. Jewish problem in the Polish Communist Party

    Directory of Open Access Journals (Sweden)

    Cimek Henryk

    2016-12-01

    Full Text Available Jews accounted for approx. 8-10% of the population of the Second Republic and in the communist movement (Polish Communist Party and Polish Communist Youth Union the rate was approx, 30%, while in subsequent years it much fluctuated. The percentage of Jews was the highest in the authorities of the party and in the KZMP. This had a negative impact on the position of the KPP on many issues, especially in its relation to the Second Republic.

  17. Attack polish for nickel-base alloys and stainless steels

    Science.gov (United States)

    Not Available

    1980-05-28

    A chemical attack polish and polishing procedure for use on metal surfaces such as nickel base alloys and stainless steels is described. The chemical attack polich comprises FeNO/sub 3/, concentrated CH/sub 3/COOH, concentrated H/sub 2/SO/sub 4/ and H/sub 2/O. The polishing procedure includes saturating a polishing cloth with the chemical attack polish and submicron abrasive particles and buffing the metal surface.

  18. Experimental Polish-Lithuanian Corpus with the Semantic Annotation Elements

    Directory of Open Access Journals (Sweden)

    Danuta Roszko

    2015-06-01

    Full Text Available Experimental Polish-Lithuanian Corpus with the Semantic Annotation Elements In the article the authors present the experimental Polish-Lithuanian corpus (ECorpPL-LT formed for the idea of Polish-Lithuanian theoretical contrastive studies, a Polish-Lithuanian electronic dictionary, and as help for a sworn translator. The semantic annotation being brought into ECorpPL-LT is extremely useful in Polish-Lithuanian contrastive studies, and also proves helpful in translation work.

  19. Validation and cross-cultural adaptation of the Polish version of the Oswestry Disability Index.

    Science.gov (United States)

    Miekisiak, Grzegorz; Kollataj, Marta; Dobrogowski, Jan; Kloc, Wojciech; Libionka, Witold; Banach, Mariusz; Latka, Dariusz; Sobolewski, Tomasz; Sulewski, Adam; Nowakowski, Andrzej; Kiwic, Grzegorz; Pala, Adam; Potaczek, Tomasz; Gierlotka, Maciej

    2013-02-15

    Validation of a translated, culturally adapted questionnaire. To translate and culturally adapt a Polish version of the Oswestry Disability Index (ODI) and to validate its use in Polish patients. The ODI is among the most popular questionnaires used to evaluate back pain-related disability. To our knowledge no validated Polish version of the index was available at the time our study was initiated. The questionnaire was translated and culturally adapted by 2 independent translators and approved by expert committee. Final version was included in the booklet consisting in addition of a previously validated Roland-Morris disability questionnaire, VAS for low back and leg and 3 Likert scale questions (pain medications, pain frequency, disability). It was tested on 169 patients with chronic low back pain, 164 (97%) of them were enrolled, and 84 of 164 (53%) returned the completed retest booklet within 2 to 14 days after the baseline test. There were no differences between the 2 groups in demographic and clinical parameters. Test-retest reliability, internal consistency, and construct validity were investigated. The mean ODI (standard deviation [SD]) was 48.45 (18.94); minimum 2, maximum 94. The Cronbach α for baseline questionnaires (n = 164) was 0.90. Concurrent validity, measured by comparing ODI responses with the results of the Roland-Morris disability questionnaire score was very good (r = 0.607, P disability in Polish-speaking patients with lower back pain.

  20. Conformal polishing approach: Tool footprint analysis

    Directory of Open Access Journals (Sweden)

    José A Dieste

    2016-02-01

    Full Text Available Polishing process is one of the most critical manufacturing processes during a metal part production because it determines the final quality of the product. Free-form surface polishing is a handmade process with lots of rejected parts, scrap generation and time and energy consumption. Two different research lines are being developed: prediction models of the final surface quality parameters and an analysis of the amount of material removed depending on the polishing parameters to predict the tool footprint during the polishing task. This research lays the foundations for a future automatic conformal polishing system. It is based on rotational and translational tool with dry abrasive in the front mounted at the end of a robot. A tool to part concept is used, useful for large or heavy workpieces. Results are applied on different curved parts typically used in tooling industry, aeronautics or automotive. A mathematical model has been developed to predict the amount of material removed in function of polishing parameters. Model has been fitted for different abrasives and raw materials. Results have shown deviations under 20% that implies a reliable and controllable process. Smaller amount of material can be removed in controlled areas of a three-dimensional workpiece.

  1. Laser polishing of additive manufactured Ti alloys

    Science.gov (United States)

    Ma, C. P.; Guan, Y. C.; Zhou, W.

    2017-06-01

    Laser-based additive manufacturing has attracted much attention as a promising 3D printing method for metallic components in recent years. However, surface roughness of additive manufactured components has been considered as a challenge to achieve high performance. In this work, we demonstrate the capability of fiber laser in polishing rough surface of additive manufactured Ti-based alloys as Ti-6Al-4V and TC11. Both as-received surface and laser-polished surfaces as well as cross-section subsurfaces were analyzed carefully by White-Light Interference, Confocal Microscope, Focus Ion Beam, Scanning Electron Microscopy, Energy Dispersive Spectrometer, and X-ray Diffraction. Results revealed that as-received Ti-based alloys with surface roughness more than 5 μm could be reduce to less than 1 μm through laser polishing process. Moreover, microstructure, microhardness and wear resistance of laser-polished zone was investigated in order to examine the thermal effect of laser polishing processing on the substrate of additive manufactured Ti alloys. This proof-of-concept process has the potential to effectively improve the surface roughness of additive manufactured metallic alloy by local polishing method without damage to the substrate.

  2. Interculutral Polish-Chinese QQing

    Directory of Open Access Journals (Sweden)

    Elżbieta Gajek

    2012-12-01

    Full Text Available Working in tandem with the use of information and communication technologies is well-known and frequently used as a method of supporting learning of foreign languages in authentic communication. It is based on a constructivist approach to teaching. In the reported case study Polish and Chinese students discussed in English preprepared topics. The work shows the potential of e-learning at the micro level, as the language and intercultural task is implemented into an academic course without modification of the objectives and learning outcomes of the course. Evaluation carried out at the end of the project indicates that both groups perceived the task as a significant linguistic, cultural and personal experience. They stressed the importance of sharing “culture for culture” as the partner culture was new for most of them. The ability to talk and respond to information which was often strange, from the point of view of their own culture, allowed for learning intercultural competence ̔in action’.

  3. Challenges in the research ethics review of cluster randomized trials: international survey of investigators.

    Science.gov (United States)

    Chaudhry, Shazia H; Brehaut, Jamie C; Grimshaw, Jeremy M; Weijer, Charles; Boruch, Robert; Donner, Allan; Eccles, Martin P; McRae, Andrew D; Saginur, Raphael; Skea, Zoë C; Zwarenstein, Merrick; Taljaard, Monica

    2013-04-01

    Cluster randomized trials (CRTs) complicate the interpretation of standard research ethics guidelines for several reasons. For one, the units of allocation, intervention, and observation often may differ within a single trial. In the absence of tailored and internationally accepted ethics guidelines for CRTs, researchers and research ethics committees have no common standard by which to judge ethically appropriate practices in CRTs. Moreover, lack of familiarity with and consideration of the unique features of the CRT design by research ethics committees may cause difficulties in the research ethics review process, and amplify problems such as variability in the requirements and decisions reached by different research ethics committees. We aimed to characterize research ethics review of CRTs, examine investigator experiences with the ethics review process, and assess the need for ethics guidelines for CRTs. An electronic search strategy implemented in MEDLINE was used to identify and randomly sample 300 CRTs published in English language journals from 2000 to 2008. A web-based survey with closed- and open-ended questions was administered to corresponding authors in a series of six contacts. The survey response rate was 64%. Among 182 of 285 eligible respondents, 91% indicated that they had sought research ethics approval for the identified CRT, although only 70% respondents reported research ethics approval in the published article. Nearly one-third (31%) indicated that they have had to meet with ethics committees to explain aspects of their trials, nearly half (46%) experienced variability in the ethics review process in multijurisdictional trials, and 38% experienced negative impacts of the ethics review process on their trials, including delays in trial initiation (28%), increased costs (10%), compromised ability to recruit participants (16%), and compromised methodological quality (9%). Most respondents (74%; 95% confidence interval (CI): 67%-80%) agreed or

  4. A Scoping Study on the Ethics of Health Systems Research.

    Science.gov (United States)

    Bachani, Abdulgafoor M; Rattani, Abbas; Hyder, Adnan A

    2016-12-01

    Currently, health systems research (HSR) is reviewed by the same ethical standards as clinical research, which has recently been argued in the literature to be an inappropriate standard of evaluation. The issues unique to HSR warrant a different review by research ethics committees (RECs), as it does not impose the same risks to study participants as other types of clinical or public health research. However, there are limited tools and supporting documents that clarify the ethical considerations. Therefore, there is a need for additional reflection around ethical review of HSR and their consideration by RECs. The purpose of this paper is to review, understand, and synthesize the current state of literature and practice to inform these deliberations and the larger discourse on ethics review guidelines for HSR. This paper presents a review of the literature on ethics of HSR in the biomedical, public health, and implementation research to identify ethical considerations specific to HSR; and to identify examples of commonly available guidance and/or tools for the ethical review of HSR studies. Fifteen articles were identified on HSR ethics issues, and forty-two international academic institutions were contacted (of the responses (n=29), no institution had special ethical guidelines for reviewing HSR) about their HSR ethics review guidelines. There appears to be a clear gap in the current health research ethics discourse around health systems research ethics. This review serves as a first step (to better understand the current status) towards a larger dialogue on the topic. © 2016 John Wiley & Sons Ltd.

  5. Abusing ethics

    DEFF Research Database (Denmark)

    Olivares Bøgeskov, Benjamin Miguel

    This paper presents the result from our research on how nurse managers use and occasionally misuse inconclusive ethical arguments to engage their personnel in current reforms. The Danish health care system has undergone a series of reforms inspired by New Public Management theories, which have...... promised better services for lower costs. Despite the positive intention, such reforms have not always been received as such by front line nurses, who often see an opposition between these processes with their focus on efficiency and the fundamental values of nursing. In this climate, nurse managers......, paying special attention to the way in which ethical arguments are used in relation to engagement. Our research shows that ethical arguments are extremely common, and they are used either to elicit engagement, or to demand engagement considering the result of a duty. However, most interestingly...

  6. Data Ethics

    DEFF Research Database (Denmark)

    Hasselbalch, Gry; Tranberg, Pernille

    Respect for privacy and the right to control one’s own data are becoming key parameters to gain a competitive edge in today’s business world. Companies, organisations and authorities which view data ethics as a social responsibility, giving it the same importance as environmental awareness...... concerned about a lack of control over their data, but they also have begun to act. In addition, they describe alternative business models, advances in technology and a new European data protection regulation, all of which combine to foster a growing market for data-ethical products and services...... and respect for human rights, are tomorrow’s winners. Digital trust is paramount to digital growth and prosperity. This book combines broad trend analyses with case studies to examine companies which use data ethics to varying degrees. The authors make the case that citizens and consumers are no longer just...

  7. Data Ethics

    DEFF Research Database (Denmark)

    Hasselbalch, Gry; Tranberg, Pernille

    Respect for privacy and the right to control one’s own data are becoming key parameters to gain a competitive edge in today’s business world. Companies, organisations and authorities which view data ethics as a social responsibility, giving it the same importance as environmental awareness...... and respect for human rights, are tomorrow’s winners. Digital trust is paramount to digital growth and prosperity. This book combines broad trend analyses with case studies to examine companies which use data ethics to varying degrees. The authors make the case that citizens and consumers are no longer just...... concerned about a lack of control over their data, but they also have begun to act. In addition, they describe alternative business models, advances in technology and a new European data protection regulation, all of which combine to foster a growing market for data-ethical products and services...

  8. Monitoring 'monitoring' and evaluating 'evaluation': an ethical framework for monitoring and evaluation in public health.

    Science.gov (United States)

    Gopichandran, Vijayaprasad; Indira Krishna, Anil Kumar

    2013-01-01

    Monitoring and evaluation (M&E) is an essential part of public health programmes. Since M&E is the backbone of public health programmes, ethical considerations are important in their conduct. Some of the key ethical considerations are avoiding conflicts of interest, maintaining independence of judgement, maintaining fairness, transparency, full disclosure, privacy and confidentiality, respect, responsibility, accountability, empowerment and sustainability. There are several ethical frameworks in public health, but none focusing on the monitoring and evaluation process. There is a need to institutionalise the ethical review of M&E proposals. A theoretical framework for ethical considerations is proposed in this paper. This proposed theoretical framework can act as the blueprint for building the capacity of ethics committees to review M&E proposals. A case study is discussed in this context. After thorough field testing, this practical and field-based ethical framework can be widely used by donor agencies, M&E teams, institutional review boards and ethics committees.

  9. Knowledge awareness and attitude about research ethics among dental faculties in India.

    Science.gov (United States)

    Gopinath, Nithin Manchery; John, Joseph; Senthilkumar, E; Nagappan, N

    2014-09-01

    The aim of this study was to assess the level of knowledge, awareness and attitude about research ethics and research ethics committees (RECs) among dental faculties. This cross-sectional questionnaire study incorporated a self administered questionnaire. Descriptive, Chi-square and logistic regression analysis was used to analyze the data. The overall response rate to the study was 85%. More than half were familiar with research ethics, principles and functions of the research ethics committee. Though there were some faculties whose attitude regarding research ethics principle was not optimal. The present study revealed a broad acceptance among the faculties acceptance toward RECs and training in research ethics, though there existed certain gap in knowledge about research among the faculties. This will help us to understand the knowledge, awareness and attitudes of dental faculties toward research ethics, which will help the institutional officials to develop better educational programs in the field of research ethics in order to help them conduct better research henceforth.

  10. The effect of nurses' ethical leadership and ethical climate perceptions on job satisfaction.

    Science.gov (United States)

    Özden, Dilek; Arslan, Gülşah Gürol; Ertuğrul, Büşra; Karakaya, Salih

    2017-01-01

    The development of ethical leadership approaches plays an important role in achieving better patient care. Although studies that analyze the impact of ethical leadership on ethical climate and job satisfaction have gained importance in recent years, there is no study on ethical leadership and its relation to ethical climate and job satisfaction in our country. This descriptive and cross-sectional study aimed to determine the effect of nurses' ethical leadership and ethical climate perceptions on their job satisfaction. The study sample is composed of 285 nurses who agreed to participate in this research and who work at the internal, surgical, and intensive care units of a university hospital and a training and research hospital in İzmir, Turkey. Data were collected using Ethical Leadership Scale, Hospital Ethical Climate Scale, and Minnesota Satisfaction Scale. While the independent sample t-test, analysis of variance, Mann-Whitney U test, and Kruskal-Wallis test were used to analyze the data, the correlation analysis was used to determine the relationship between the scales. Ethical considerations: The study proposal was approved by the ethics committee of the Faculty of Medicine, Dokuz Eylül University. The nurses' mean scores were 59.05 ± 14.78 for the ethical leadership, 92.62 ± 17 for the ethical climate, and 62.15 ± 13.46 for the job satisfaction. The correlation between the nurses' ethical leadership and ethical climate mean scores was moderately positive and statistically significant (r = +0.625, p = 0.000), was weak but statistically significant between their ethical leadership and job satisfaction mean scores (r = +0.461, p = 0.000), and was moderately positive and statistically significant between their ethical climate and job satisfaction mean scores (r = +0.603, p = 0.000). The nurses' ethical leadership, ethical climate, and job satisfaction levels are moderate, and there is a positive relationship between them. The nurses' perceptions of ethical

  11. Comissões de ética de enfermagem em instituições de saúde de Ribeirão Preto Comisiones de ética de enfermería en instituciones de salud del interior del estado de São Paulo -- Brasil Nursing ethics committees in Ribeirão Preto's healthcare institutions

    Directory of Open Access Journals (Sweden)

    Cátia Ducati

    2001-05-01

    Full Text Available O estudo teve como objetivo identificar hospitais de Ribeirão Preto que possuem Comissões de Ética de Enfermagem, estabelecidas de acordo com a Decisão do Conselho Regional de Enfermagem, verificar suas atividades e atribuições, os motivos da criação e observância à Legislação. Os resultados mostram que dos 11 hospitais visitados oito teriam obrigatoriedade de instituir Comissões e destes, apenas três a possuem, sendo que somente uma encontra-se efetivamente em atividade. O estudo possibilitou também identificar infrações éticas mais freqüentes assim como punições eventualmente aplicadas e evidenciou despreparo dos profissionais da Enfermagem em relação ao seu posicionamento perante essas Comissões.El estudio tuvo como objetivo identificar que hospitales de Ribeirão Preto tienen Comisiones de Ética de Enfermería, establecidas de acuerdo con la decisión del COREN; verificar sus actividades y atribuciones, los motivos de la creación y el cumplimiento de la legislación. Los resultados muestran que de los once hospitales visitados, 8 deberían conformar obligatoriamente Comisiones. De estos solamente 3 la poseen y solo una se encuentra en actividad. El estudio posibilitó también identificar algunas infracciones éticas más frecuentes así como los castigos eventualmente aplicados y mostró la falta de preparación de los profesionales de Enfermería en relación con su posición frente a las Comisiones.The aim of this study was to identify hospitals in Ribeirão Preto, Brazil which have a Nursing Ethics Committee established according to the Decision of the Nursing Regional Council, to examine their activities and attributions, the reasons why they were created and the enforcement of legislation. The results have shown that from the eleven hospitals visited, eight ought to have instituted their Committees; however, only three had done it and only one of them was effectively active. The study made it possible to

  12. Ethics, big data and computing in epidemiology and public health.

    Science.gov (United States)

    Salerno, Jennifer; Knoppers, Bartha M; Lee, Lisa M; Hlaing, WayWay M; Goodman, Kenneth W

    2017-05-01

    This article reflects on the activities of the Ethics Committee of the American College of Epidemiology (ACE). Members of the Ethics Committee identified an opportunity to elaborate on knowledge gained since the inception of the original Ethics Guidelines published by the ACE Ethics and Standards of Practice Committee in 2000. The ACE Ethics Committee presented a symposium session at the 2016 Epidemiology Congress of the Americas in Miami on the evolving complexities of ethics and epidemiology as it pertains to "big data." This article presents a summary and further discussion of that symposium session. Three topic areas were presented: the policy implications of big data and computing, the fallacy of "secondary" data sources, and the duty of citizens to contribute to big data. A balanced perspective is needed that provides safeguards for individuals but also furthers research to improve population health. Our in-depth review offers next steps for teaching of ethics and epidemiology, as well as for epidemiological research, public health practice, and health policy. To address contemporary topics in the area of ethics and epidemiology, the Ethics Committee hosted a symposium session on the timely topic of big data. Technological advancements in clinical medicine and genetic epidemiology research coupled with rapid advancements in data networks, storage, and computation at a lower cost are resulting in the growth of huge data repositories. Big data increases concerns about data integrity; informed consent; protection of individual privacy, confidentiality, and harm; data reidentification; and the reporting of faulty inferences. Copyright © 2017 Elsevier Inc. All rights reserved.

  13. Polishing for glass ceramics: which protocol?

    Science.gov (United States)

    Silva, Tânia Mara da; Salvia, Ana Carolina Rodrigues Danzi; Carvalho, Rodrigo Furtado de; Pagani, Clovis; Rocha, Daniel Maranha da; Silva, Eduardo Galera da

    2014-07-01

    The execution of adjustments on ceramic restorations is sometimes necessary for either correction of occlusion and/or inadequate contours or esthetical improvements. Clinically, the surfaces undergo weariness through fine grinding diamond burs which remove the superficial glazing layer. Several materials for ceramic polishing have been used in an attempt to reach a satisfactory surface smoothness. The aim of this study was to perform a literature review on different polishing protocols of several dental ceramics. This is a literature review performed through scientific articles published between 2004 and 2012, indexed in MEDLINE, PubMed and Scielo databases. The study selected and analyzed a total of 20 relevant articles that evaluated different types of ceramics, polishing treatment and surface roughness. After an extensive literature review, this study observed: 1 - after the rupture of the glazing layer due to the adjustments of the restorations, the best choice for the polishing of the surface will depend on the type of ceramics used; 2 - glazing procedure provide excellent results regarding to the superficial smoothness; however, if reglazing is impossible, either abrasive rubber cups/points or sandpaper discs followed by the use of diamond polishing pastes results in a satisfactory superficial smoothness; 3 - clinical studies that take into account the behavior of the protocols polishing are scarce and should be encouraged; 4 - the large number of variables influence the final outcome of polishing should be considered. The necessity in standardization of methodologies to enable a comparison among researches. Copyright © 2014 Japan Prosthodontic Society. Published by Elsevier Ltd. All rights reserved.

  14. Smoking characteristics of Polish immigrants in Dublin.

    LENUS (Irish Health Repository)

    Kabir, Zubair

    2008-01-01

    BACKGROUND: This study examined two main hypotheses: a) Polish immigrants\\' smoking estimates are greater than their Irish counterparts (b) Polish immigrants purchasing cigarettes from Poland smoke "heavier" (>\\/= 20 cigarettes a day) when compared to those purchasing cigarettes from Ireland. The study also set out to identify significant predictors of \\'current\\' smoking (some days and everyday) among the Polish immigrants. METHODS: Dublin residents of Polish origin (n = 1,545) completed a previously validated Polish questionnaire in response to an advertisement in a local Polish lifestyle magazine over 5 weekends (July-August, 2007). The Office of Tobacco Control telephone-based monthly survey data were analyzed for the Irish population in Dublin for the same period (n = 484). RESULTS: Age-sex adjusted smoking estimates were: 47.6% (95% Confidence Interval [CI]: 47.3%; 48.0%) among the Poles and 27.8% (95% CI: 27.2%; 28.4%) among the general Irish population (p < 0.001). Of the 57% of smokers (n = 345\\/606) who purchased cigarettes solely from Poland and the 33% (n = 198\\/606) who purchased only from Ireland, 42.6% (n = 147\\/345) and 41.4% (n = 82\\/198) were "heavy" smokers, respectively (p = 0.79). Employment (Odds Ratio [OR]: 2.89; 95% CI: 1.25-6.69), lower education (OR: 3.76; 95%CI: 2.46-5.74), and a longer stay in Ireland (>24 months) were significant predictors of current smoking among the Poles. An objective validation of the self-reported smoking history of a randomly selected sub-sample immigrant group, using expired carbon monoxide (CO) measurements, showed a highly significant correlation coefficient (r = 0.64) of expired CO levels with the reported number of cigarettes consumed (p < 0.0001). CONCLUSION: Polish immigrants\\' smoking estimates are higher than their Irish counterparts, and particularly if employed, with only primary-level education, and are overseas >2 years.

  15. Overview on health research ethics in Egypt and North Africa.

    Science.gov (United States)

    Marzouk, Diaa; Abd El Aal, Wafaa; Saleh, Azza; Sleem, Hany; Khyatti, Meriem; Mazini, Loubna; Hemminki, Kari; Anwar, Wagida A

    2014-08-01

    Developing countries, including Egypt and North African countries, need to improve their quality of research by enhancing international cooperation and exchanges of scientific information, as well as competing for obtaining international funds to support research activities. Research must comply with laws and other requirements for research that involves human subjects. The purpose of this article is to overview the status of health research ethics in Egypt and North African countries, with reference to other Middle Eastern countries. The EU and North African Migrants: Health and Health Systems project (EUNAM) has supported the revision of the status of health research ethics in Egypt and North African countries, by holding meetings and discussions to collect information about research ethics committees in Egypt, and revising the structure and guidelines of the committees, as well as reviewing the literature concerning ethics activities in the concerned countries. This overview has revealed that noticeable efforts have been made to regulate research ethics in certain countries in the Middle East. This can be seen in the new regulations, which contain the majority of protections mentioned in the international guidelines related to research ethics. For most of the internationally registered research ethics committees in North African countries, the composition and functionality reflect the international guidelines. There is growing awareness of research ethics in these countries, which extends to teaching efforts to undergraduate and postgraduate medical students. © The Author 2014. Published by Oxford University Press on behalf of the European Public Health Association. All rights reserved.

  16. The adequacy of the ethics review process in Malaysia: protection of the interests of mentally incapacitated adults who enrol in clinical trials

    OpenAIRE

    Kaur, S.

    2011-01-01

    The objective of this thesis is to answer the question, “does the ethics committee review process in Malaysia provide meaningful protection to mentally incapacitated adults who enrol in clinical research trials?” This question is answered by examining three important aspects of the ethics review process. First, the quality of the deliberations of ethics committees is examined by looking at the underlying principles that are meant to guide ethics decision-making. Second, the ...

  17. Transgressive ethics

    DEFF Research Database (Denmark)

    Hoeyer, Klaus; Jensen, Anja Marie Bornø

    2013-01-01

    of treatment norms, we must move close to everyday work practices and appreciate the importance of material–technical treatment options as well as the interplay of professional ethics and identity. The cardiac treatment of brain-dead donors may thereby illuminate how treatment norms develop on the ground...

  18. Capability ethics

    NARCIS (Netherlands)

    I.A.M. Robeyns (Ingrid)

    2012-01-01

    textabstractThe capability approach is one of the most recent additions to the landscape of normative theories in ethics and political philosophy. Yet in its present stage of development, the capability approach is not a full-blown normative theory, in contrast to utilitarianism, deontological

  19. APS 3D: a new benchmark in aspherical polishing

    Science.gov (United States)

    Gauch, Daniel; Mikulic, Dalibor; Veit, Christian

    2017-10-01

    The APS 3D system performs polishing and form correction in one step in order to reduce overall process time, reduce the number of polishing steps required and eliminate the need for highly skilled operators while providing a repeatable polishing process. This new 3D Polishing system yields better surface quality, and a better slope error, automatically determining the optimum speeds, feed rates and polish pressures to achieve a deterministic process based on the required quality parameters input by the operator. The process flow is always the same to ensure consistent quality and target quality values are defined before polishing begins.

  20. Sexual development and behaviour issues in Polish teenage magazines.

    Science.gov (United States)

    Kopacz, Marek S

    2006-12-01

    Adolescents often look to mass media for information regarding issues of sexuality. As one form of media, teenage magazines have long constituted a pervasive and effective element of adolescent media exposure. Teenage magazines discuss a number of aspects concerning adolescent sexuality. Considering their potential impact on health related behaviors, the information they provide and the message(s) they send warrant attention. The aim of this study is to perform a content analysis of sexual development and behavior information presented in Polish teenage magazines. Social Cognitive Theory was used as a theoretical basis for this analysis. The media chosen for this study were general-themed publications targeting an adolescent female audience: Bravo Girl!, Filipinka and Dziewczyna. Each entry was analyzed using a structured key. The specific categories of behavior and development used for this study are: biological information, pedagogic instruction, topics of moral-ethical concern, results of sexual activity, and interpersonal relationships. Each category was then subdivided into separate units. The findings indicate that Polish teenage magazines predominantly focus on relationships, contraception and sex education. Relationships were most often of a romantic nature and discussed sexual activity or the potential of sexual activity. Non-prescription contraceptive methods were most often discussed, with attention given to pregnancy prevention. Sex education offered detailed information on sexual practices and behaviors with much discussion on losing one's virginity. The general approach of the analyzed magazines is that adolescents currently are, or soon will be, sexually active. As a result, certain sexual behavior and development issues are discussed in great detail, while other topics are somewhat neglected. Accepting information-seeking during adolescence as commonplace, these findings suggest that teenage magazines hold the potential for influencing adolescent

  1. Preliminary ethical appraisal of a trial - what's it all about?

    Science.gov (United States)

    Siipi, Helena

    Preliminary ethical appraisal of medical trials is often based on the following four principles: respect for autonomy, beneficence, non-maleficence, and justice. Preliminary ethical appraisal should, however, not be understood solely as application of these four principles to practice. Ethical committees will inevitably interpret the principles and make decisions about their reciprocal importance in connection with each trial. Reasoning does not always proceed from above towards practical recommendations of action, but can instead also be based on a moral rule or practice relating to a certain action. A good preliminary ethical appraisal will also take into account everyday standards of morality, law and shared moral values of the society.

  2. [Ethics and occupational physicians: ethics and mission required for occupational physicians].

    Science.gov (United States)

    Fujino, Akihiro

    2013-10-01

    The ethics of occupational physicians are considered from the following three viewpoints: (1) their legal standing and ethics in job execution; (2) ethics in research in occupational medicine; and (3) ethics in the 21st century and fundamental issues. We discuss: in (1), the contract types of occupational physicians and their independency and neutrality, the protection of health information and privacy, and the use of authority and the security measures; in (2), ethical standards of medical research in Japanese and international organizations, the significance and role of ethics committees, and issues characteristic of occupational health research; and in (3), occupational physicians and politic ethics, the practical abilities and ethics necessary for occupational physicians, and the practice and philosophy of occupational medicine as an art. These considerations suggest that occupational physicians, who have a special status based on the governmental policy of the occupational physician system, should develop an ethical consciousness at the core of their duties and perform their mission with responsibility to employees and employers, all of whom are Japanese citizens. Finally, we propose that the ultimate mission of occupational physicians is "to practice occupational medicine as a branch of the humanities."

  3. Do Ethics Classes Teach Ethics?

    Science.gov (United States)

    Curzer, Howard J.; Sattler, Sabrina; DuPree, Devin G.; Smith-Genthôs, K. Rachelle

    2014-01-01

    The ethics assessment industry is currently dominated by the second version of the Defining Issues Test (DIT2). In this article, we describe an alternative assessment instrument called the Sphere-Specific Moral Reasoning and Theory Survey (SMARTS), which measures the respondent's level of moral development in several respects. We describe eight…

  4. Researchers’ perceptions of ethical challenges in cluster randomized trials: a qualitative analysis

    Directory of Open Access Journals (Sweden)

    McRae Andrew D

    2013-01-01

    Full Text Available Abstract Background Cluster randomized trials (CRTs pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1 ethical challenges in CRTs; (2 the ethics review process for CRTs; and (3 the need for comprehensive ethics guidelines for CRTs. Methods Descriptive qualitative analysis of interviews conducted with a purposive sample of 20 experienced CRT researchers. Results Informants expressed concern over the potential for bias that may result from requirements to obtain informed consent from research participants in CRTs. Informants suggested that the need for informed consent ought to be related to the type of intervention under study in a CRT. Informants rarely expressed concern regarding risks to research participants in CRTs, other than risks to privacy. Important issues identified in the research ethics literature, including fair subject selection and other justice issues, were not mentioned by informants. The ethics review process has had positive and negative impacts on CRT conduct. Informants stated that variability in ethics review between jurisdictions, and increasingly stringent ethics review in recent years, have hampered their ability to conduct CRTs. Many informants said that comprehensive ethics guidelines for CRTs would be helpful to researchers and research ethics committees. Conclusions Informants identified key ethical challenges in the conduct of CRTs, specifically relating to identifying subjects, seeking informed consent, and the use of gatekeepers. These data have since been used to identify topics for in-depth ethical analysis and to guide the development of comprehensive ethics guidelines for CRTs.

  5. Material removal mechanisms in abrasive vibration polishing of complex molds

    Science.gov (United States)

    Brinksmeier, E.; Riemer, O.; Schulte, H.

    2010-10-01

    Optical and medical industries are demanding a large variety of optical elements exhibiting complex geometries and multitude opto-functional areas in the range of a few millimeters [1]. Therefore, mold inserts made of steel or carbides must be finished by polishing for the replication of glass and plastic lenses [2]. For polishing theses complex components in the shape of localized cavities or grooves the application of rotating polishing pads is very limited. Established polishing processes are not applicable, so state of the art is a time consuming and therefore expensive polishing procedures by hand. An automated process with conventional polishing machines is impossible because of the complex mold insert geometry. The authors will present the development of a new abrasive polishing process for finishing these complex mold geometries to optical quality. The necessary relative velocity in the contact area between polishing pad and workpiece surface is exclusively realized by vibration motions which is an advantage over vibration assisted rotating polishing processes. The absence of rotation of the pad opens up the possibility to machine new types of surface geometries. The specific influence factors of vibration polishing were analyzed and will be presented. The determination of material removal behavior and polishing effect on planar steel samples has shown that the conventional abrasive polishing hypothesis of Preston is applicable to the novel vibration polishing process. No overlaid chemical material removal appears.

  6. Polish Academy of Sciences Great Dictionary of Polish [Wielki słownik języka polskiego PAN

    Directory of Open Access Journals (Sweden)

    Piotr Žmigrodzki

    2014-12-01

    Full Text Available The paper describes a lexicographical project involving the development of the newest general dictionary of the Polish language: the Polish Academy of Sciences Great Dictionary of Polish [Wielki słownik języka polskiego PAN]. The project is coordinated by the Institute of Polish Language at the Polish Academy of Sciences and carried out in collaboration with linguists and lexicographers from several other Polish academic centres. The paper offers a brief description of the genesis of the project and the scope of information included in the dictionary, the organisation of work, the life of the dictionary on the Web as well as the plans for the future.

  7. Computer and Applied Ethics

    OpenAIRE

    越智, 貢

    2014-01-01

    With this essay I treat some problems raised by the new developments in science and technology, that is, those about Computer Ethics to show how and how far Applied Ethics differs from traditional ethics. I take up backgrounds on which Computer Ethics rests, particularly historical conditions of morality. Differences of conditions in time and space explain how Computer Ethics and Applied Ethics are not any traditional ethics in concrete cases. But I also investigate the normative rea...

  8. A mixed-method systematic review: support for ethical competence of nurses.

    Science.gov (United States)

    Poikkeus, Tarja; Numminen, Olivia; Suhonen, Riitta; Leino-Kilpi, Helena

    2014-02-01

    The aim was to appraise and synthesize evidence of empirical studies of how nurses' ethical competence can be supported. Ethical competence is an essential element of nursing practice. Nurses increasingly need support in competence when carrying out their responsibilities towards their patients. A mixed-method systematic review of quantitative and qualitative studies was undertaken according to the University of York's Centre for Reviews and Dissemination guidelines. Searches of MEDLINE, Nursing Database and British Nursing Index databases were conducted, yielding 512 citations between 1985-2012. After a two-stage application of inclusion and exclusion criteria, 34 articles were included. The quality of the studies was assessed using STROBE or COREQ criteria. Data were analysed by content analysis. Nurses' ethical competence has been studied from different viewpoints: ethical decision-making, ethical sensitivity, ethical knowledge and ethical reflection. There was little empirical evidence of provided support, but studies offered recommendations on how to support ethical competence. The most common strategies to support ethical competence were ethics education, ethics rounds, ethics committee and consultation. Nurse leaders and colleagues have a key role in providing opportunities for nurses to gain ethical competence. There is a need to develop evidence-based support at the organizational and individual level to support nurses' ethical competence. Barriers for multiprofessional cooperation in ethical issues should be recognized and addressed as part of the development of organizational ethical practices. Research should pay more attention to the conceptual, theoretical and practical perspectives of ethical competence. © 2013 John Wiley & Sons Ltd.

  9. Executive committee

    Science.gov (United States)

    Xiao, Guoqing; Cai, Xiaohong; Ding, Dajun; Ma, Xinwen; Zhao, Yongtao

    2014-04-01

    ChairVice Chair Toshiyuki AzumaRoberto Rivarola Atomic, Molecular & Optical Physics LabUniversidad Nacional de Rosario and Advanced Science InstituteInstituto de Fisica Rosario RIKEN, JapanRosario, Argentina SecretaryMembers Dominique VernhetJoachim Burgdörfer, Austria Institut des NanoSciences de Paris Birgit Lohmann, Australia Université Pierre et Marie Curie Hossein Sadeghpour, USA Paris, FranceThomas Stöhlker, Germany Past ChairJim McCann, UK Barry DunningGuoqing Xiao, China Physics & AstronomyXiaohong Cai, China Rice University, HoustonXinwen Ma, China Texas, USAYongtao Zhao, China TreasurerFernando Martin, Spain Henrik CederquistLuis Mendez, Spain Alba Nova University CenterAnatoli Kheifets, Australia Stockholm University Stockholm, Sweden Details of the general committee are available in the PDF

  10. Surface Roughness and Gloss of Actual Composites as Polished With Different Polishing Systems.

    Science.gov (United States)

    Rodrigues-Junior, S A; Chemin, P; Piaia, P P; Ferracane, J L

    2015-01-01

    This in vitro study evaluated the effect of polishing with different polishing systems on the surface roughness and gloss of commercial composites. One hundred disk-shaped specimens (10 mm in diameter × 2 mm thick) were made with Filtek P-90, Filtek Z350 XT, Opallis, and Grandio. The specimens were manually finished with #400 sandpaper and polished by a single operator using three multistep systems (Superfix, Diamond Pro, and Sof-lex), one two-step system (Polidores DFL), and one one-step system (Enhance), following the manufacturer's instructions. The average surface roughness (μm) was measured with a surface profilometer (TR 200 Surface Roughness Tester), and gloss was measured using a small-area glossmeter (Novo-Curve, Rhopoint Instrumentation, East Sussex, UK). Data were analyzed by two-way analysis of variance and Tukey's test (α=0.05). Statistically significant differences in surface roughness were identified by varying the polishing systems (pGrandio when polished with Sof-Lex and Filtek Z250 and Opallis when polished with Enhance. Gloss was influenced by the composites (p<0.0001), the polishing systems (p<0.0001), and the interaction between them (p<0.0001). The one-step system, Enhance, produced the lowest gloss for all composites. Surface roughness and gloss were affected by composites and polishing systems. The interaction between both also influenced these surface characteristics, meaning that a single polishing system will not behave similarly for all composites. The multistep systems produced higher gloss, while the one-step system produced the highest surface roughness and the lowest gloss of all.

  11. Environmental ethics.

    Science.gov (United States)

    Steinberg, J J

    2000-03-01

    The U.S. Environmental Protection Agency (EPA) held the first meeting on environmental ethics sponsored by the Scientific Advisory Panel and Board on 10-11 December 1998 in Arlington, Virginia (1). The report from the meeting will more completely inform scientists and the community of current issues. This editorial should serve as an initial brief of this meeting [which was held on the fiftieth anniversary of the Declaration of Human Rights (adopted by the United Nations on 10 December 1948)].

  12. 77 FR 14591 - Open Meeting of the Federal Advisory Committee on Insurance

    Science.gov (United States)

    2012-03-12

    [email protected] . Paper Statements Send paper statements in triplicate to the Federal Advisory... meeting Committee members will be introduced and briefed on applicable ethics standards as well as the...

  13. 78 FR 23827 - Veterans' Advisory Committee on Rehabilitation, Notice of Meeting

    Science.gov (United States)

    2013-04-22

    ... annual report. On May 2, the Committee members will receive an annual ethics briefing and discuss meeting... NW., Washington, DC 20420, or via email at [email protected] . In the communication with the...

  14. Scientific Publication Ethics

    Directory of Open Access Journals (Sweden)

    Osman İnci

    2015-06-01

    showing conscious deceptive intention. Duplication, salamislicing, publications aiming partiality, partiality in choice of sources, authorship rights violations (Author concealment, Gift Autorship, Honory Autorship or Ghost Autorship,author addition changing the order of author list, and not thanking to the contributers are other irregular applications. Innocent faults and carelessness should not be evaluated as irregular applications. It is the task and responsibility of administrators of academic committee, editors and publication committees, referees, supporting institutions, and mainly academic readers and writers to avoid irregular applications in academic publications. It is of vital importance to give ‘an academic ethics’ instructions just at the very beginning of academic life. The ones who do not know principles and rules of academic ethics are not efficient for academic research and publications. Besides sanctions should be applied against approved irregular applications.

  15. [The biologization of ethics].

    Science.gov (United States)

    Moreno Lax, Alejandro

    2010-01-01

    Three ethics exist as a condition of possibility of any possible ethics, following a material and biological foundation. This content argument (not logical-formal) supposes a refutation of the naturalistic fallacy that the analytical philosophy attributes to Hume, in three areas of the ethical human experience: body, society and nature. These are: the ethics of the species [J. Habermas], the ethics of liberation [E. Dussel] and the ethics of the responsibility [H. Jonas]. This material argument is a philosophical foundation to considering for three types of applied ethics: medical bioethics, development ethics and environmental ethics.

  16. e-Government Ethics : a Synergy of Computer Ethics, Information Ethics, and Cyber Ethics

    OpenAIRE

    Arief Ramadhan; Dana Indra Sensuse; Aniati Murni Arymurthy

    2011-01-01

    Ethics has become an important part in the interaction among humans being. This paper specifically discusses applied ethics as one type of ethics. There are three applied ethics that will be reviewed in this paper, i.e. computer ethics, information ethics, and cyber ethics. There are two aspects of the three applied ethics that were reviewed, i.e. their definition and the issues associated with them. The reviewing results of the three applied ethics are then used for defining e-Government eth...

  17. Can ethics survive the onslaught of science?

    Science.gov (United States)

    Lupton, Michael

    2013-09-01

    core of ethics which is sacrosanct or is every ethical frontier fair game for invasion? Are the Ethics Committees, which approve and monitor research in the field of bioethics in Universities. Hospitals and laboratories failing in their duty as gatekeepers? They are after all the first line of defence for the survival of crucial ethical values. Can we continue to indulge the whims and needs of every individual under the guise of human rights or patient autonomy? Can a civilised society endure as such with an ever diminishing mass of ethical values?

  18. Ethical considerations for field research on fishes

    Directory of Open Access Journals (Sweden)

    Rhett H. Bennett

    2016-12-01

    field research to minimise impacts on fish populations. It is envisaged that this review will be a useful resource for journal editorial committees intending to introduce ethical requirements for publication and for researchers, managers, conservation practitioners and research organisations when designing field studies on fishes, applying for ethical clearance and developing institutional ethical guidelines.

  19. Resolving the ethical dilemma of nurse managers over chemically-dependent colleagues.

    Science.gov (United States)

    Chiu, W; Wilson, D

    1996-12-01

    This paper addresses the nurse manager's role regarding chemically-dependent nurses in the workplace. The manager may intervene by: terminating the contract of the impaired colleague; notifying a disciplinary committee; consulting with a counselling committee; or referring the impaired nurse to an employee assistance programme. A dilemma may arise about which of these interventions is ethically the best. The ethical theories relevant to nursing involve ethical relativism, utilitarianism, Kantian ethics, Kohlberg's justice, and Gilligan's ethic of care. Nurse managers first need to understand these theories in order to clarify their own perceptions and attitudes towards chemical dependency, and then satisfactorily resolve this ethical dilemma. Education and social learning are routes to a better understanding of chemical dependency and to broadening the ethical dimensions of nurse managers.

  20. Ethics for life scientists

    NARCIS (Netherlands)

    Korthals, M.J.J.A.A.; Bogers, R.J.

    2004-01-01

    In this book we begin with two contributions on the ethical issues of working in organizations. A fruitful side effect of this start is that it gives a good insight into business ethics, a branch of applied ethics that until now is far ahead of ethics for life scientists. In the second part, ethics

  1. The Ethic of Community

    Science.gov (United States)

    Furman, Gail C.

    2004-01-01

    This article proposes the concept of an ethic of community to complement and extend other ethical frames used in education e.g. the ethics of justice, critique, and care. Proceeding from the traditional definition of ethics as the study of moral duty and obligation, ethic of community is defined as the moral responsibility to engage in communal…

  2. Desenvolvimento da dimensão educacional dos Comitês de Ética em Pesquisa (CEPs Desarrollo de la dimensión educacional de los Comités de Ética en Investigación (CEPs Development of the educational dimension of ethics of research committees (ERCs

    Directory of Open Access Journals (Sweden)

    Adriana Silva Barbosa

    2012-06-01

    66,7% de los investigadores participantes tuvieron alguna aproximación ética en su trayectoria académica. Estos datos indican que los CEIs necesitan mayor apoyo institucional e inversión para la consolidación de su dimensión educativo-consultiva.The importance of the educational and consulting nature of ethics of research committees (ERCs highlights the value of research which studies these dimensions in the committees. Aims: to analyze how ERCs have carried out their educational and consulting role; to learn whether advisors have some training in research ethics; to identify whether researchers had guidance about research ethics in their academic career. This is a quantitative and descriptive study approved by CEP/UESB under protocol 134/2009, carried out with 95 informants and analyzed by Software Sphinx. According to data obtained, nearly 71.5% research participants consider educational and consulting activities carried out by ERC infrequent or lacking; 60% participants have some ethical training in their academic career. These data show that ERCs need greater institutional support and funding in order to consolidate their educational-consulting dimension.

  3. Microbiological flora and nail polish: a brief report.

    Science.gov (United States)

    Rayan, G M; Flournoy, D J; Schlageter, P

    1994-11-01

    Removing nail polish and prosthetic nails from operating room (OR) personnel prior to scrubbing and from patients prior to hand surgery is recommended but not practiced in many hospitals. There is concern that nail polish can act as a vehicle for the transfer of infectious agents. This study was designed to determine the incidence of microbiological flora of nail polish in a clinical setting.

  4. Monitoring of Robot Assisted Polishing through parameters of acoustic emission

    DEFF Research Database (Denmark)

    Lazarev, Ruslan; Top, Søren; Bilberg, Arne

    The polishing process is essential for the surface generation of machine tooling components in advanced manufacturing. While robot assisted polishing is faster and more consistent than manual polishing, it can still consume a significant part of ma- chining time and operator presence time...

  5. 21 CFR 872.6030 - Oral cavity abrasive polishing agent.

    Science.gov (United States)

    2010-04-01

    ... 21 Food and Drugs 8 2010-04-01 2010-04-01 false Oral cavity abrasive polishing agent. 872.6030... (CONTINUED) MEDICAL DEVICES DENTAL DEVICES Miscellaneous Devices § 872.6030 Oral cavity abrasive polishing agent. (a) Identification. An oral cavity abrasive polishing agent is a device in paste or powder form...

  6. Out of the frying pan? Streamlining the ethics review process of multisite qualitative research projects.

    Science.gov (United States)

    Iedema, Rick A M; Allen, Suellen; Britton, Kate; Hor, Suyin

    2013-05-01

    This paper describes the ethics approval processes for two multicentre, nationwide, qualitative health service research projects. The paper explains that the advent of the National Ethics Application Form has brought many improvements, but that attendant processes put in place at local health network and Human Research Ethics Committee levels may have become significantly more complicated, particularly for innovative qualitative research projects. The paper raises several questions based on its analysis of ethics application processes currently in place. WHAT IS KNOWN ABOUT THE TOPIC? The complexity of multicentre research ethics applications for research in health services has been addressed by the introduction of the National Ethics Application Form. Uptake of the form across the country's human research ethics committees has been uneven. WHAT DOES THIS PAPER ADD? This paper adds detailed insight into the ethics application process as it is currently enacted across the country. The paper details this process with reference to difficulties faced by multisite and qualitative studies in negotiating access to research sites, ethics committees' relative unfamiliarity with qualitative research , and apparent tensions between harmonisation and local sites' autonomy in approving research. WHAT ARE THE IMPLICATIONS FOR PRACTITIONERS? Practitioners aiming to engage in research need to be aware that ethics approval takes place in an uneven procedural landscape, made up of variable levels of ethics approval harmonization and intricate governance or site-specific assessment processes.

  7. Reconsidering 'ethics' and 'quality' in healthcare research: the case for an iterative ethical paradigm.

    Science.gov (United States)

    Stevenson, Fiona A; Gibson, William; Pelletier, Caroline; Chrysikou, Vasiliki; Park, Sophie

    2015-05-08

    UK-based research conducted within a healthcare setting generally requires approval from the National Research Ethics Service. Research ethics committees are required to assess a vast range of proposals, differing in both their topic and methodology. We argue the methodological benchmarks with which research ethics committees are generally familiar and which form the basis of assessments of quality do not fit with the aims and objectives of many forms of qualitative inquiry and their more iterative goals of describing social processes/mechanisms and making visible the complexities of social practices. We review current debates in the literature related to ethical review and social research, and illustrate the importance of re-visiting the notion of ethics in healthcare research. We present an analysis of two contrasting paradigms of ethics. We argue that the first of these is characteristic of the ways that NHS ethics boards currently tend to operate, and the second is an alternative paradigm, that we have labelled the 'iterative' paradigm, which draws explicitly on methodological issues in qualitative research to produce an alternative vision of ethics. We suggest that there is an urgent need to re-think the ways that ethical issues are conceptualised in NHS ethical procedures. In particular, we argue that embedded in the current paradigm is a restricted notion of 'quality', which frames how ethics are developed and worked through. Specific, pre-defined outcome measures are generally seen as the traditional marker of quality, which means that research questions that focus on processes rather than on 'outcomes' may be regarded as problematic. We show that the alternative 'iterative' paradigm offers a useful starting point for moving beyond these limited views. We conclude that a 'one size fits all' standardisation of ethical procedures and approach to ethical review acts against the production of knowledge about healthcare and dramatically restricts what can be

  8. Professional Training of Economists at Polish Universities

    Science.gov (United States)

    Ogienko, Olena

    2016-01-01

    Polish experience in professional training of economists at university has been generalized. Structural, content and procedural peculiarities of the training have been defined. It has been proved that key factors for reforming economic education in Poland are globalization, internationalization, integration, technologization and informatization.…

  9. Knowledge Mobilisation in the Polish Education System

    Science.gov (United States)

    Fazlagic, Jan; Erkol, Arif

    2015-01-01

    Poland has made substantial progress in improving the quality of its education system in recent years. This paper aims to describe the situation of the Polish education system from a knowledge management perspective and, to some extent, through innovation policies in education. The many challenges, this paper argues, can be tackled only through…

  10. Sexual Health of Polish Athletes with Disabilities

    Directory of Open Access Journals (Sweden)

    Ryszard Plinta

    2015-06-01

    Full Text Available The purpose of this study was to determine sexual functioning of Polish athletes with disabilities (including paralympians. The study encompassed 218 people with physical disabilities, aged between 18 and 45 (149 men and 69 women. The entire research population was divided into three groups: Polish paralympians (n = 45, athletes with disabilities (n = 126 and non-athletes with disabilities (n = 47. The quality of sexual life of Polish paralympians was measured by using the Polish version of Female Sexual Function Index and International Index of Erectile Function. Clinically significant erectile dysfunctions were most often diagnosed in non-athletes (83.33% with 50% result of severe erectile dysfunctions, followed by athletes and paralympians with comparable results of 56.98% and 54.17% respectively (p = 0.00388. Statistically significant clinical sexual dysfunctions concerned lubrication, orgasm as well as pain domains, and prevailed among female non-athletes (68.42%, 68.42% and 57.89%. Practising sports at the highest level has a favourable effect on the sexuality of men and women with physical disabilities. Men with physical disabilities manifest more sexual disorders than women, an aspect which should be considered by health-care professionals working with people with disabilities.

  11. Technological Advances of Robot Assisted Polishing

    DEFF Research Database (Denmark)

    Lazarev, Ruslan; Top, Søren; Grønbæk, Jens

    The efficient polishing of surfaces is very important in mould and die industry. Fine abrasive processes are widely used in industry for the first steps for the production of tools of high quality in terms of finishing accuracy, form and surface integrity. While manufacturing of most components r...

  12. Polish Complementary Schools in Iceland and England

    Science.gov (United States)

    Zielinska, Malgorzata; Kowzan, Piotr; Ragnarsdóttir, Hanna

    2014-01-01

    Since 2004, the opening of labour markets has spurred a considerable number of Poles to emigrate e.g. to Iceland and England. Families with school age children have had the challenge of adapting to foreign environments and school systems. Polish complementary schools have played an important, albeit ambivalent, role in this process. Through focus…

  13. Transformation of the Polish Banking Sector

    Directory of Open Access Journals (Sweden)

    Marek Stefański

    2009-07-01

    Full Text Available In the post-war period the banking system in Poland underwent two important system transitions: after 1946 and after 1989. The third transformation began after May 1, 2004, but it did not have a systemic character. The Polish banking sector started to operate on the Single European Market. The first part of the paper is devoted to the problems of the banks transformations after 1989 with a special focus on the quantitative development of banks in 19892008, and on subsequent privatisation and consolidation processes. The former intensified in 19891999, and the latter in 19992002. The consolidation process was very noticeable in the sector of cooperative banks after 1994. The second part of the paper includes an economic and financial analysis of the banks. A lot of attention was paid to the liquidity of the banking sector. It was assessed as good, which was confirmed by a short-term rating of Moodys and by the Financial Stability Report 2009, published by the National Bank of Poland in June 2009. The comparison of the net profit of the banking sector in 19972008 shows its dependence on the economic situation and policy. The number of banks with capital adequacy ratio well above the minimum required by the banking supervision is rising. The financial power ratings are not favorable for the domestic banks. The third part of the paper focuses on the development directions of the Polish banking sector. It may be concluded on the basis of the analysis that privatisation and consolidation processes will be continued. They will concentrate on the capital of foreign banks already operating in Poland. As compared with individual foreign banks, the potential of the Polish banking sector is week. The fourth part of the paper focuses on the presentation Polish banking sector in the context of European Union banking sector. The paper finishes with conclusions. Generally, Polish banks have to implement a strategy to enable them to compete on the Single

  14. Approaches in handling ethical challenges of cancer treatment and research in Nigeria.

    Science.gov (United States)

    Adejumo, A O

    2009-06-01

    The diagnosis of cancer can devastate the physical, emotional, and socio-economic life of an individual. Caring for most cancer patients presents serious ethical challenges to physicians and other health workers. Inclusion of cancer patients in research could be no less challenging. These ethical problems become significantly magnified in the context of patients who have cancer in a low resource environment characterized by high illiteracy rate, poverty and poor health care infrastructure. Some of the ethical problems include: palliative care and end of life issues, particularly since most patients present in advanced stages, withholding or withdrawal of life support, global equity and justice in drug availability, drug pricing, cancer research and breaking bad news. Adherence to ethical guidelines in conducting cancer research would go a long way in reducing harms and unethical conducts. Similarly, the relevance of clinical and research ethics committees in resolving complex ethical issues in clinical practice has been suggested. However, where these are in place, the need for recourse to philosophical approach, especially virtue ethics in analyzing and resolving ethical concerns in clinical practice cannot be overemphasized. This paper highlights the burden of cancer in Nigeria and the ethical challenges of clinical management of cancer patients, using a case study. The role of clinical ethics and health research ethics committees as well as the justification for virtue ethics above principlism in handling ethical issues in cancer management and research in Nigeria were highlighted.

  15. Exploring perceptions and experiences of Bolivian health researchers with research ethics.

    Science.gov (United States)

    Sullivan, Sarah; Aalborg, Annette; Basagoitia, Armando; Cortes, Jacqueline; Lanza, Oscar; Schwind, Jessica S

    2015-04-01

    In Bolivia, there is increasing interest in incorporating research ethics into study procedures, but there have been inconsistent application of research ethics practices. Minimal data exist regarding the experiences of researchers concerning the ethical conduct of research. A cross-sectional study was administered to Bolivian health leaders with research experience (n = 82) to document their knowledge, perceptions, and experiences of research ethics committees and infrastructure support for research ethics. Results showed that 16% of respondents reported not using ethical guidelines to conduct their research and 66% indicated their institutions did not consistently require ethics approval for research. Barriers and facilitators to incorporate research ethics into practice were outlined. These findings will help inform a comprehensive rights-based research ethics education program in Bolivia. © The Author(s) 2015.

  16. Chemical mechanical glass polishing with cerium oxide: Effect of selected physico-chemical characteristics on polishing efficiency

    Czech Academy of Sciences Publication Activity Database

    Janoš, P.; Ederer, J.; Pilařová, V.; Henych, Jiří; Tolasz, Jakub; Milde, D.; Opletal, T.

    2016-01-01

    Roč. 362, SEP (2016), s. 114-120 ISSN 0043-1648 R&D Projects: GA MŠk(CZ) LM2015073 Institutional support: RVO:61388980 Keywords : Chemical mechanical polishing * Ceria-based polishing powders * Polishing efficienc Subject RIV: CA - Inorganic Chemistry Impact factor: 2.531, year: 2016

  17. Ethics and psychological research

    DEFF Research Database (Denmark)

    Søndergaard, Dorte Marie

    Human subjects and social relations are crucial in research psychologists’ ethical considerations. Lists of ethical criteria - including how to anonymize data, avoid causing harm, handle asymmetries – are pivotal. A situated ethics inspired by new materialism and poststructuralism would, however,...

  18. Biblical Ethics and Plotinus

    DEFF Research Database (Denmark)

    Pontoppidan, Maria

    2013-01-01

    This article focuses on the question of unification versus relationality in ethics. It compares two different ethical approaches from Late Antiquity, highlighting the contrast between Plotinian (Neoplatonic) ethics as striving for perfect unification of the human soul with the divinity...

  19. Contribution of the ethics committee of the French society of intensive care medicine to a scenario for the implementation of organ donation after Maastricht III-type cardiac death in France.

    Science.gov (United States)

    Graftieaux, J-P; Bollaert, P-E; Haddad, L; Kentish-Barnes, N; Nitenberg, G; Robert, R; Villers, D; Dreyfuss, D

    2014-02-01

    French law allows organ donation after death due to cardiocirculatory arrest. In the Maastricht classification, type III non-heart-beating donors are those who experience cardiocirculatory arrest after the withdrawal of life-sustaining treatments. French authorities in charge of regulating organ donation (Agence de la Biomédecine, ABM) are considering organ collection from Maastricht type III donors. We describe a scenario for Maastricht type III organ donation that fully complies with the ethical norms governing care to dying patients. That organ donation may occur after death should have no impact on the care given to the patient and family. The dead-donor rule must be followed scrupulously: the organ retrieval procedure must neither cause nor hasten death. The decision to withdraw life-sustaining treatments, withdrawal modalities, and care provided to the patient and family must adhere strictly to the requirements set forth in patient-rights legislation (the 2005 Léonetti law in France) and should not be influenced in any way by the possibility of organ donation. A major ethical issue regarding the family is how best to transition from discussing treatment-withdrawal decisions to discussing possible organ retrieval for donation should the patient die rapidly after treatment withdrawal. Close cooperation between the healthcare team and the organ retrieval team is crucial to minimize the distress of family members during this transition. Modalities for implementing Maastricht type III organ donation are discussed here, including the best location for withdrawing life-sustaining treatments (operating room or intensive care unit). Copyright © 2014. Published by Elsevier SAS.

  20. Animal ethics

    DEFF Research Database (Denmark)

    Palmer, Clare; Sandøe, Peter

    2011-01-01

    This chapter describes and discusses different views concerning our duties towards animals. First, we explain why it is necessary to engage in thinking about animal ethics and why it is not enough to rely on feelings alone. Secondly, we present and discuss five different kinds of views about the ...... the nature of our duties to animals. They are: contractarianism, utilitarianism, the animal rights view, contextual views, and a respect for nature view. Finally, we briefly consider whether it is possible to combine elements from the presented views, and how to make up one’s mind....

  1. Applied and Professional Ethics

    OpenAIRE

    Collste, Göran

    2012-01-01

    The development of applied ethics in recent decades has had great significance for philosophy and society. In this article, I try to characterise this field of philosophical inquiry. I also discuss the relation of applied ethics to social policy and to professional ethics. In the first part, I address the following questions: What is applied ethics? When and why did applied ethics appear? How do we engage in applied ethics? What are the methods? In the second part of the article, I introduce...

  2. An Approach on Ethic

    OpenAIRE

    Kesgin, Ahmet; KESGİN, Ahmet

    2015-01-01

    Ethics is philosophical thought which human behavior’s scope of moral is subject. However, by effectuating the principles of moral is to be in the life. In this regard, although not exactly the same is to be fulfilled the function of the concept of morality. There are ussually common oponion which ethics, a philosophical topic, is three kinds. These are descriptive ethics, normative ethics and metaethics. The main characteristics of these types of ethical are: Descriptive ethics depict existi...

  3. Adaptation of the Four Forms of Employee Silence Scale in a Polish sample

    Directory of Open Access Journals (Sweden)

    Krystyna Adamska

    2017-06-01

    Full Text Available Background Silence is understood as a decision not to speak up in situations of observed irregularities both in productivity and ethics. The study examined the validity of the Four Forms of Employee Silence Scale (FFESS in the Polish population. The scale is a four-factor measure designed to capture differently motivated tendencies to be silent in organizations. The scale distinguishes acquiescent, quiescent, prosocial and opportunistic silence. Employee silence has been linked to many important individual outcomes: failure to react to ethical transgressions, stress and depression, and lower creativity and productivity. Participants and procedure A total of 1044 employees of various organizations working for at least six months at a given position provided the responses for the validation study. Results The results confirmed the superiority of the four-factor model shown by adequate fit indexes: The FFESS has adequate internal consistency at both the scale and item levels. The criterion-related validity of the scale was established by correlating four forms of silence with measures of emotional attitude toward organization, procedural justice, relational contract and turnover intention. Conclusions The four forms of employee silence are empirically distinct concepts in the Polish sample. The scale may be used as the measurement of individual differences. It can also serve as a tool for diagnosing a climate of silence in an organization.

  4. STUDY OF POLISHING AISI 316L WITH STRUCTURED ABRASIVE

    Directory of Open Access Journals (Sweden)

    François GOOSSENS

    2015-05-01

    Full Text Available Finishing process like polishing is usually used to obtain high quality mechanical surface characteristics such as texture and roughness. These operations are mainly handmade and need highly trained operators thus limiting their repeatability and profitability. To optimize the industrialization of the polishing process, it is therefore necessary to modelize the process to built efficient parameter database. The aim of this study is to characterise the polishing of 316L stainless steel with structured abrasive belts. The geometric data of the belts are given, and we then propose a model to determine material removal. An experimental test bench is set up to test this model and characterise the polishing process in terms of forces. It produces samples for different polishing conditions. The different polished surfaces are then analyzed thanks to the roughness and the wettability. Using experimental designs, we are able to validate the proposed model and identify the parameters that influence a polishing operation.

  5. The science of ethics: Deception, the resilient self, and the APA code of ethics, 1966-1973.

    Science.gov (United States)

    Stark, Laura

    2010-01-01

    This paper has two aims. The first is to shed light on a remarkable archival source, namely survey responses from thousands of American psychologists during the 1960s in which they described their contemporary research practices and discussed whether the practices were "ethical." The second aim is to examine the process through which the American Psychological Association (APA) used these survey responses to create principles on how psychologists should treat human subjects. The paper focuses on debates over whether "deception" research was acceptable. It documents how members of the committee that wrote the principles refereed what was, in fact, a disagreement between two contemporary research orientations. The paper argues that the ethics committee ultimately built the model of "the resilient self" into the APA's 1973 ethics code. At the broadest level, the paper explores how prevailing understandings of human nature are written into seemingly universal and timeless codes of ethics. © 2010 Wiley Periodicals, Inc.

  6. Women, children and advertising - legal and ethical aspects

    OpenAIRE

    Stejskalová, Radka

    2012-01-01

    The thesis titled "Women, children and advertising - legal and ethical aspects" deals with the portrayal of women and children in advertising. The aim of the thesis is to analyze advertising with a focus on the portrayal of women and children present to Arbitration Committee in the reporting period and propose recommendations for the future. The work also deals with the importance of legal and ethical rules that regulate advertising and focuses on content regulation of women and children.

  7. Transferring embryos with indeterminate PGD results: the ethical implications

    OpenAIRE

    Insogna, Iris G.; Ginsburg, Elizabeth

    2016-01-01

    Background In vitro fertilization (IVF) and pre-implantation genetic diagnosis (PGD) are becoming increasingly common techniques to select embryos that are unaffected by a known genetic disorder. Though IVF-PGD has high success rates, 7.5?% of blastocysts have inconclusive results after testing. A recent case involving a known BRCA-1 carrier was brought before our Assisted Reproductive Technology Ethics Committee in order to gain a better appreciation for the ethical implications surrounding ...

  8. 76 FR 76732 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-12-08

    ...). Management support for the activities of this Committee is the responsibility of the OASH. The qualified... Secretary for Health. The Committee shall advise on a range of policy issues to include: (1) Definition of... health, ethical, and legal issues related to transfusion and transplantation safety, and (3) the...

  9. 76 FR 15982 - Nominations to the Advisory Committee on Blood Safety and Availability

    Science.gov (United States)

    2011-03-22

    ... Committee is the responsibility of the OASH. The qualified individuals will be nominated to the Secretary of... Committee shall advise on a range of policy issues to include: (1) Definition of public health parameters around safety and availability of the blood supply and blood products, (2) broad public health, ethical...

  10. Teaching and evaluation of ethics and professionalism

    Science.gov (United States)

    Pauls, Merril A.

    2012-01-01

    Abstract Objective To document the scope of the teaching and evaluation of ethics and professionalism in Canadian family medicine postgraduate training programs, and to identify barriers to the teaching and evaluation of ethics and professionalism. Design A survey was developed in collaboration with the Committee on Ethics of the College of Family Physicians of Canada. The data are reported descriptively and in aggregate. Setting Canadian postgraduate family medicine training programs. Participants Between June and December of 2008, all 17 Canadian postgraduate family medicine training programs were invited to participate. Main outcome measures The first part of the survey explored the structure, resources, methods, scheduled hours, and barriers to teaching ethics and professionalism. The second section focused on end-of-rotation evaluations, other evaluation strategies, and barriers related to the evaluation of ethics and professionalism. Results Eighty-eight percent of programs completed the survey. Most respondents (87%) had learning objectives specifically for ethics and professionalism, and 87% had family doctors with training or interest in the area leading their efforts. Two-thirds of responding programs had less than 10 hours of scheduled instruction per year, and the most common barriers to effective teaching were the need for faculty development, competing learning needs, and lack of resident interest. Ninety-three percent of respondents assessed ethics and professionalism on their end-of-rotation evaluations, with 86% assessing specific domains. The most common barriers to evaluation were a lack of suitable tools and a lack of faculty comfort and interest. Conclusion By far most Canadian family medicine postgraduate training programs had learning objectives and designated faculty leads in ethics and professionalism, yet there was little curricular time dedicated to these areas and a perceived lack of resident interest and faculty expertise. Most programs

  11. Ethics, Ricoeur And Philosophy: Ethical Teacher Workshops

    Science.gov (United States)

    Scott-Baumann, Alison

    2006-01-01

    This work is about the ethics of education, and about philosophy as a discipline that can help us to help children look at ethics afresh. The study and practice of ethics is about morals and uncertainties and, as such, poses problems for the research community. The philosopher Ricoeur challenges research as only one way to find meaning in the…

  12. Teaching Business Ethics or Teaching Business Ethically?

    Science.gov (United States)

    Stablein, Ralph

    2003-01-01

    Notes that one of the most important contexts for ethical decision-making is the nature and operation of "contemporary capitalisms." Suggests that rather than issuing a call for teaching business ethics, the author emphasizes the need for more ethical business teaching. (SG)

  13. Behavioral Ethics and Teaching Ethical Decision Making

    Science.gov (United States)

    Drumwright, Minette; Prentice, Robert; Biasucci, Cara

    2015-01-01

    Business education often renders students less likely to act ethically. An infusion of liberal learning in the form of behavioral ethics could improve this situation by prompting students to develop higher levels of professionalism that encompass ethics, social responsibility, self-critical reflection, and personal accountability. More…

  14. From reactive to proactive: developing a valid clinical ethics needs assessment survey to support ethics program strategic planning (part 1 of 2).

    Science.gov (United States)

    Frolic, Andrea; Jennings, Barb; Seidlitz, Wendy; Andreychuk, Sandy; Djuric-Paulin, Angela; Flaherty, Barb; Peace, Donna

    2013-03-01

    As ethics committees and programs become integrated into the "usual business" of healthcare organizations, they are likely to face the predicament of responding to greater demands for service and higher expectations, without an influx of additional resources. This situation demands that ethics committees and programs allocate their scarce resources (including their time, skills and funds) strategically, rather than lurching from one ad hoc request to another; finding ways to maximize the effectiveness, efficiency, impact and quality of ethics services is essential in today's competitive environment. How can Hospital Ethics Committees (HECs) begin the process of strategic priority-setting to ensure they are delivering services where and how they are most needed? This paper describes the creation of the Clinical Ethics Needs Assessment Survey (CENAS) as a tool to understand interprofessional staff perceptions of the organization's ethical climate, challenging ethical issues and educational priorities. The CENAS was designed to support informed resource allocation and advocacy by HECs. By sharing our process of developing and validating this ethics needs assessment survey we hope to enable strategic priority-setting in other resource-strapped ethics programs, and to empower HECs to shift their focus to more proactive, quality-focused initiatives.

  15. The Brewsters: A new resource for interprofessional ethics education.

    Science.gov (United States)

    Rozmus, Cathy L; Carlin, Nathan; Polczynski, Angela; Spike, Jeffrey; Buday, Richard

    2015-11-01

    One of the barriers to interprofessional ethics education is a lack of resources that actively engage students in reflection on living an ethical professional life. This project implemented and evaluated an innovative resource for interprofessional ethics education. The objective of this project was to create and evaluate an interprofessional learning activity on professionalism, clinical ethics, and research ethics. The Brewsters is a choose-your-own-adventure novel that addresses professionalism, clinical ethics, and research ethics. For the pilot of the book, a pre-test/post-test design was used. Once implemented across campus, a post-test was used to evaluate student learning in addition to a student satisfaction survey. A total of 755 students in six academic schools in a health science center completed the activity as part of orientation or in coursework. The project was approved as exempt by the university's Committee for the Protection of Human Subjects. The pilot study with 112 students demonstrated a significant increase in student knowledge. The 755 students who participated in the project had relatively high knowledge scores on the post-test and evaluated the activity positively. Students who read The Brewsters scored well on the post-test and had the highest scores on clinical ethics. Clinical ethics scores may indicate issues encountered in mass media. The Brewsters is an innovative resource for teaching interprofessional ethics and professionalism. Further work is needed to determine whether actual and long-term behavior is affected by the activity. © The Author(s) 2014.

  16. SPECTRAL METHODS IN POLISH EMOTIONAL SPEECH RECOGNITION

    Directory of Open Access Journals (Sweden)

    Paweł Powroźnik

    2016-12-01

    Full Text Available In this article the issue of emotion recognition based on Polish emotional speech signal analysis was presented. The Polish database of emotional speech, prepared and shared by the Medical Electronics Division of the Lodz University of Technology, has been used for research. Speech signal has been processed by Artificial Neural Networks (ANN. The inputs for ANN were information obtained from signal spectrogram. Researches were conducted for three different spectrogram divisions. The ANN consists of four layers but the number of neurons in each layer depends of spectrogram division. Conducted researches focused on six emotional states: a neutral state, sadness, joy, anger, fear and boredom. The averange effectiveness of emotions recognition was about 80%.

  17. Polish 2012 growth references for preschool children.

    Science.gov (United States)

    Kułaga, Zbigniew; Grajda, Aneta; Gurzkowska, Beata; Góźdź, Magdalena; Wojtyło, Małgorzata; Swiąder, Anna; Różdżyńska-Świątkowska, Agnieszka; Litwin, Mieczysław

    2013-06-01

    Growth references are useful in monitoring a child's growth, which is an essential part of child care. The aim of this paper is to provide updated growth references for Polish preschool children and to assess how well children in Poland match or diverge from the World Health Organization (WHO) growth standards/references and recent German height-for-age references. The height-, weight-, body mass index-for-age, and weight-for-height references were constructed with the LMS method using data from a recent, large, population-representative sample of 4,941 preschool children aged 3 to 6 years (the OLA study). In the case of boys, the third, 50th, and 97th height percentiles of new Polish and German references overlap almost completely, whereas the WHO growth standards/references percentiles are systematically lower. In the case of girls, comparison between the new Polish and German height references showed conformity on the third and 50th percentile, whereas body height values of the WHO standards/references are shorter. Polish children aged 3 to 6 years from for the nation representative sample, had significantly greater than zero mean z scores of height-, weight-, and BMI-for-age and weight-for-height, relative to the WHO growth standards/references. The number of children in the sample with height-for-age below -2 SD was significantly lower than expected and number of children with height-for-age above +2 SD was significantly higher than expected. The OLA study growth references can be recommended as national references for preschool children in Poland.

  18. Polish normalization of the Body Esteem Scale

    Directory of Open Access Journals (Sweden)

    Małgorzata Lipowska

    2014-02-01

    Full Text Available Background Physical attractiveness plays an important part in one’s social functioning. The interest in one’s own appearance have been documented as widespread among the female population, but over the recent years it is more and more often emphasized that concentrating on body appearance concerns men as well. Franzoi and Shields (1984 created the Body Esteem Scale which allows to qualify the subject’s attitude towards his or her own body. The aim of the study was to create a Polish version of the Body Esteem Scale along with the norms for age and sex clusters. Participants and procedure The normalization sample consisted of 4298 participants: 1865 women aged 16 to 80 (M = 29.92; SD = 12.85 and 2433 men aged 16 to 78 (M = 28.74; SD = 11.50. Education levels among the participants were also controlled for. In order to create a Polish version of the Body Esteem Scale, translation was adopted as the adaptation strategy. Like the original one, the Polish scale comprises 35 items grouped into three gender specific subscales. The subscales for women include Sexual Attractiveness, Weight Concern, and Physical Condition, whereas the body esteem of is examined with regards to Physical Attractiveness, Upper Body Strength, and Physical Condition. Results Reliability of subscales was high both for females (Cronbach’s alpha from 0.80 to 0.89 and males (Cronbach’s alpha from 0.85 to 0.88. The given coefficients of reliability cover the original division into subscales adopted by the authors of BES. Conclusions We confirmed high reliability of the Polish version of the Body Esteem Scale, thus we recommend it as a diagnostic tool. Created norms allowed to refer results obtained in the course of research carried out on people with various disorders (e.g. eating disorders or body dysmorphic disorder with population data for corresponding age brackets.

  19. Polish Martial Law: The Crisis of Communism

    Science.gov (United States)

    2009-12-01

    Roman Catholic Church continued to exist, and a comparatively liberal cultural policy was in place, which continued a legitimate practice of most of...intervention. Their answers verify that for most Poles the fear 29 of losing sovereignty and Polish culture to Russian aggression overshadows all else, even...they going in? They did not,” Woodrow Wilson International Center for Scholars, http://www.wilsoncenter.org/news/ docs/ Historia -Jachranka%20-%20Stan

  20. The Polish Cyborg. A Reflection on the Relationship between Man and Machine in Early Polish Modernism

    Directory of Open Access Journals (Sweden)

    Emiliano Ranocchi

    2016-12-01

    Full Text Available Far from being enthusiastic “modernolatry” of Italian futurism, Polish futurism demonstrates an attitude of ambivalence toward modernity. This is particularly evident in the Polish approach to that very synecdoche of modernity which is the machine. In his essay of 1923, the leader of the group, Bruno Jasieński, compares the fetishistic cult of the machine, which characterizes the Italian approach, with the utilitarian one of the Russians, exemplified by a quote from Majakovskij. To these two propositions, as a sort of Hegelian synthesis, he adds a Polish one consisting in the conception of the machine as a prosthesis, a continuation of the human body. Thereby he introduces an idea later known as “cyborg”. The category of cyborg is also useful to understand the work of another today almost forgotten Polish writer of the Twenties, Jerzy Sosnkowski. He was the author of a short novel, A Car, You and Me (Love of Machines, in which a whole chapter concerns the chief character’s dystopian nightmare wherein machines take control over the world. The third section of the essay deals with the idea of man a machine – an old, 18th century conception, which became actual anew in the 20th century and whose traces we can find among others in a well-known poem by Tytus Czyżewski. Thirty years before N. Wiener, Polish modernists seem to have sensed the social, political and anthropological implications of the mechanization of work.

  1. Committee on Scientific Values | Initiatives | Indian Academy of ...

    Indian Academy of Sciences (India)

    The Council of the Academy had in 2003 constituted a Committee to consider and submit a report on ethical guidelines which the fellowship of the Academy should ... All India Institute of Medical Sciences, New Delhi; Sunil Mukhi, Tata Institute of Fundamental Research, Mumbai; G. Padmanaban, Indian Institute of Science, ...

  2. 76 FR 21381 - Pediatric Advisory Committee; Notice of Meeting

    Science.gov (United States)

    2011-04-15

    ... recommendation of the Pediatric Ethics Subcommittee from its meeting on May 11, 2011, regarding the Institutional Review Board process for clinical investigations that involve both an FDA regulated product and research... Committee will meet to discuss pediatric-focused safety reviews, as mandated by the Best Pharmaceuticals for...

  3. Characterization and Streptococcus mutans adhesion on air polishing dentin.

    Science.gov (United States)

    Tada, Kazuhiro; Oda, Hirotake; Inatomi, Michitomo; Sato, Soh

    2014-07-01

    Air polishing is known as an effective and time saving tooth cleaning method. However, this method increased surface roughness and bacterial adhesion on dentin surface. The aim of this study was to characterize and examine Streptococcus mutans adhesion on dentin surface after air polishing as compared to the conventional method. The dentin blocks (4 × 4 × 1 mm) were polished by a rubber cup with polishing material (Polishing) and air-polished by 25 μm glycine (G25), 65 μm glycine (G65), and 65 μm sodium bicarbonate (NHC65) microparticles. Surface roughness (Ra) was measured by a laser electron microscope. The amount of adhered S. mutans was quantified using a resazurin reduction assay (alamarBlue(®)). The Ra of G25 and G65 was significantly (p < 0.01) smaller than that of NHC65 and greater than that of Polishing. However, there was no significant difference in S. mutans adhesion among Polishing, G25, and G65, while NHC65 showed significantly (p < 0.01) higher S. mutans adhesion. Within the limitations of this in vitro study, air polishing using glycine microparticles conditioned S. mutans adhesion on dentin surface in a similar fashion than the conventional method, and less than air polishing using sodium bicarbonate microparticles.

  4. [Ethical questions in pediatrics].

    Science.gov (United States)

    Krivohlavý, J

    1992-01-01

    In the introduction the author submits association, connotations, and definitions of basic ethical terms, along with a classification of ethics. The author presents an outline of ethical problems of medicine and in particular paediatrics with an explanation why society pays special attention to these problems and why ethical self-reflection of doctors in general and paediatricians in particular is necessary.

  5. Seamless Integration of Ethics

    Science.gov (United States)

    Beggs, Jeri Mullins

    2011-01-01

    The ineffectiveness of business ethics education has received attention from the popular press and the Association to Advance Collegiate Schools of Business after repeated ethics scandals. One possibility is that teaching ethics is different from other content areas because ethics is best learned when the student does not know it is being taught.…

  6. Emerging technology and ethics

    CERN Document Server

    Wakunuma, Kutoma

    2011-01-01

    This e-book on Emerging Technologies and Ethics includes a collection of essays which explore the future and ethics of emerging information and communication technologies. Articles in the collection include an overview of the legal implications which may be relevant to the ethical aspects of emerging technologies and also ethical issues arising from the mass-take up of mobile technologies.

  7. Putting Law into Ethics.

    Science.gov (United States)

    Lieberman, Jethro K.

    1979-01-01

    The evolution of ethics in law is followed from the harshness of caveat emptor to the humanistic ethics of the 1970s, including a renewal of formal ethics in the post-Watergate era. The impact on universities and individual disciplines of legalizing ethical conduct is examined cautiously. (JMF)

  8. [Ethics in medical journals.

    Science.gov (United States)

    Lifshitz, Alberto

    2013-01-01

    The title of this reflection evokes several contents that may encompass from ethics in research; fraud in science; ethics in medical advertising and relations between sponsors and science; and, finally, papers related to ethic content. This paper is limited to the ethic responsibilities of the medical writers or "scriptwriters."

  9. Effects of polishing procedures on color stability of composite resins.

    Science.gov (United States)

    Güler, Ahmet Umut; Güler, Eda; Yücel, Ali Cağin; Ertaş, Ertan

    2009-01-01

    The purpose of this study was to investigate the effect of different polishing methods on color stability of posterior, universal and nanohybrid composite resin restorative materials upon exposure to a staining agent. Twenty-five specimens were prepared for each of 5 different composite resins (Filtek Z250, Filtek P60, Quadrant LC, Grandio and Filtek Supreme). Specimens were divided into 5 groups and different polishing procedures, including polishing discs (Pd), polishing discs then diamond polishing paste (PdP), polishing discs then a liquid polishing system (Biscover) (PdB), and combinations of these (PdPB) were used. Unpolished specimens served as the control (C). The specimens were stored for 48 h in a coffee solution. The color of all specimens was measured before and after exposure with a colorimeter, and total color change (DeltaE*) were calculated. The data were analyzed with a two-way ANOVA and the means were compared by Tukey HSD test (alpha=0.05). The lowest color difference was observed in the groups PdP and C, while the highest color difference was observed in PdPB, and PdB. When comparing the five different restorative materials, no significant difference was observed between FiltekP60 and FiltekZ250, and these materials demonstrated significantly less color change than Quadrant LC and the nanohybrid materials (Grandio, Filtek Supreme). The posterior (Filtek P60) and universal (Filtek Z250) composite resin restorative materials, which do not contain tetraethyleneglycol dimethacrylate (TEGDMA), were found to be less stainable than the nanohybrid (Grandio, Filtek Supreme) and universal (Quadrant LC) composite resins, which contain TEGDMA. The use of diamond polishing paste after polishing with polishing discs significantly decreased staining when compared to the groups that used polishing discs alone, for all restorative materials tested. The highest color change values were obtained for the specimens that were polished with the Biscover liquid polish

  10. Effects of polishing procedures on color stability of composite resins

    Directory of Open Access Journals (Sweden)

    Ahmet Umut Güler

    2009-04-01

    Full Text Available The purpose of this study was to investigate the effect of different polishing methods on color stability of posterior, universal and nanohybrid composite resin restorative materials upon exposure to a staining agent. Twenty-five specimens were prepared for each of 5 different composite resins (Filtek Z250, Filtek P60, Quadrant LC, Grandio and Filtek Supreme. Specimens were divided into 5 groups and different polishing procedures, including polishing discs (Pd, polishing discs then diamond polishing paste (PdP, polishing discs then a liquid polishing system (Biscover (PdB, and combinations of these (PdPB were used. Unpolished specimens served as the control (C. The specimens were stored for 48 h in a coffee solution. The color of all specimens was measured before and after exposure with a colorimeter, and total color change (DE* were calculated. The data were analyzed with a two-way ANOVA and the means were compared by Tukey HSD test (a=0.05. The lowest color difference was observed in the groups PdP and C, while the highest color difference was observed in PdPB, and PdB. When comparing the five different restorative materials, no significant difference was observed between FiltekP60 and FiltekZ250, and these materials demonstrated significantly less color change than Quadrant LC and the nanohybrid materials (Grandio, Filtek Supreme. The posterior (Filtek P60 and universal (Filtek Z250 composite resin restorative materials, which do not contain tetraethyleneglycol dimethacrylate (TEGDMA, were found to be less stainable than the nanohybrid (Grandio, Filtek Supreme and universal (Quadrant LC composite resins, which contain TEGDMA. The use of diamond polishing paste after polishing with polishing discs significantly decreased staining when compared to the groups that used polishing discs alone, for all restorative materials tested. The highest color change values were obtained for the specimens that were polished with the Biscover liquid polish

  11. The internist as clinical ethics consultant: An antidote to "the barbarism of specialisation" in hospital practice.

    Science.gov (United States)

    Real de Asúa, D; Rodriguez Del Pozo, P; Fins, J J

    2018-04-01

    The development of hospital clinical ethics in Spain depends almost exclusively on the healthcare ethics committees, which have been criticized for a lack of proximity to the patient's bedside in day-to-day ethical conflicts and for their scarce practical operation, reflected in the low number of consultations they receive. In this study, we reflect on the need to change the current healthcare model in clinical ethics so as to reactivate it and call attention to the essential role of internists as the engine for this change. To this end, we propose a model in which the healthcare ethics committees incorporate ethics consultants, who are better positioned to discuss cases at the patient's bedside. We then analyse the characteristics that these consultants should have. Copyright © 2017 Elsevier España, S.L.U. and Sociedad Española de Medicina Interna (SEMI). All rights reserved.

  12. Analysis of time to regulatory and ethical approval of SATVI TB ...

    African Journals Online (AJOL)

    Background. Tuberculosis (TB) vaccine trials in South Africa must be approved by the Medicines Control Council (MCC) and by a human research ethics committee (HREC). Delays in regulatory and ethical approval may affect operational and budget planning and clinical development of the product. Aim. Our aim was to ...

  13. [Centenary of the Health Council of the Netherlands. V. Ethical-social issues

    NARCIS (Netherlands)

    Have, H.A.M.J. ten

    2002-01-01

    Since its inception, the Health Council of the Netherlands has included normative aspects in its reports. Over the past decades, ethics and rights have received increasing attention, particularly since the establishment of the Standing Committee on Medical Ethics and Health Law in 1977. In

  14. Code of Ethical Conduct for Computer-Using Educators: An ICCE Policy Statement.

    Science.gov (United States)

    Computing Teacher, 1987

    1987-01-01

    Prepared by the International Council for Computers in Education's Ethics and Equity Committee, this code of ethics for educators using computers covers nine main areas: curriculum issues, issues relating to computer access, privacy/confidentiality issues, teacher-related issues, student issues, the community, school organizational issues,…

  15. Revision of Business Ethics

    OpenAIRE

    Tomas Sigmund

    2011-01-01

    Business ethics is a controversial topic. In my article I would like to explore where the limits of business ethics are and to what extent it can become part of the economic world. I would like to explore the question what the relationship between ethics and business is and whether what business ethicists consider ethics is real ethics in the fundamental sense of the world. The concept of business ethics will be discussed compared to general ethical theories and consequences drawn. I would li...

  16. The Audit Committee. AGB Effective Committee Series

    Science.gov (United States)

    Staisloff, Richard L.

    2011-01-01

    This publication is part of an Association of Governing Boards of Universities and Colleges (AGB) series devoted to strengthening the role of key standing committees of governing boards. While there is no optimum committee system for institutions of higher education, certain principles, practices, and procedures prevail. The best practices…

  17. Avoiding ethics pitfalls in publishing: a perspective from COPE.

    Science.gov (United States)

    Pierson, C A

    2017-05-01

    The mission of the Committee on Publication Ethics (COPE) is to promote integrity in research publication. COPE was started in 1997 with a small group of editors and now has a membership of more than 10 000. Throughout its history, COPE has provided a forum for discussion about ethical issues related to all aspects of scholarly publishing and developed resources to assist those who write, review, and edit scholarly work. This concise review provides examples of ethical issues related to authoring, reviewing, and editing scholarly manuscripts from the perspective of COPE. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  18. Ethics of orthodontic clinical research based on Helsinki declaration

    Directory of Open Access Journals (Sweden)

    Eka Erwansyah

    2016-06-01

    Full Text Available Declaration of Helsinki code of ethics on human experimentation, states that the desin and peformance of experimental procedures involving human should be clearly formulated in an experimental protocol, Todeterminewhetheraninvestigationin accordancewiththe code of conductin a researchthen letusconsider the contentofthe declarationhelsinkiasour referencein conductingaclinicalstudyusinghuman subjects. In journals, authors are expected to report if the study was carried out in accordance with international and national ethical guidelines and inform readers if approval from ethics committee was obtained and if written informed consent was taken from the participant or legal guardian.

  19. Advanced space optics development in freeform optics design, ceramic polishing, rapid and extreme freeform polishing

    Science.gov (United States)

    Geyl, R.; Leplan, H.; Ruch, E.

    2017-09-01

    In this paper Safran-Reosc wants to share with the space community its recent work performed in the domain of space optics. Our main topic is a study about the advantages that freeform optical surfaces can offer to advanced space optics in term of compactness or performances. We have separated smart and extreme freeform in our design exploration work. Our second topic is to answer about the immediate question following: can we manufacture and test these freeform optics? We will therefore present our freeform optics capability, report recent achievement in extreme aspheric optics polishing and introduce to the industrialisation process of large off axis optics polishing for the ESO Extremely Large Telescope primary mirror segments. Thirdly we present our R-SiC polishing layer technology for SiC material. This technique has been developed to reduce costs, risks and schedule in the manufacturing of advanced SiC optics for Vis and IR applications.

  20. Centralized National Ethical Review of Clinical Trials in Croatia

    Science.gov (United States)

    Vitezić, Dinko; Lovrek, Maja; Tomić, Siniša

    2009-01-01

    Aim To present the Croatian system of ethical review of clinical trials and assessment outcomes of the applications reviewed by the Croatian Central Ethics Committee. Methods Clinical trial applications reviewed by the Croatian Central Ethics Committee, which has the legal mandate to review clinical trials of medicinal products and medical devices, were retrospectively analyzed from May 2004 to the end of 2008 according to the number, research area, and type of opinion issued. Applications from 2008 were analyzed separately according to the study phase, participants (adult trials vs pediatric trials), and sponsor (commercial trials vs academic trials). Data were analyzed by descriptive statistics. Results Since its establishment in 2004, the Croatian Central Ethics Committee has reviewed 407 trials. The greatest number of clinical trials was in the field of oncology (n = 69), mental and behavioral disorders (n = 52), and endocrine, nutritional, and metabolic diseases (n = 50). In the initial assessment of clinical trials, 60% applications received a conditionally positive opinion. In 28% of applications, the opinion had to be postponed because additional documentation or explanations were required. In 2008, the Croatian Central Ethics Committee reviewed 99 trials, most of which were phase III trials (n = 57). Five clinical trials included pediatric population and 3 were academic clinical trials. Conclusion The model of centralized clinical trial review seems to be appropriate for the current number of clinical trials conducted in Croatia. The efficient and standardized review process of clinical trials by the Central Ethics Committee may positively affect the increasing number of clinical trials conducted in Croatia. Future development includes the transparency of the clinical trials through a publically available database and establishing the basis for conducting academic clinical trials. PMID:19399943

  1. COMMUNICATION, ETHICS AND ANTHROPOETHICS

    OpenAIRE

    Luiz Martins da Silva

    2009-01-01

    The purpose of this article is to dream of – in the sense ofestablishing – the utopian perspective of a scenario that remains utopian but which nonetheless provides the first indications that we may be entering a new paradigm, that of communication-ethics, that is to say, the ethical dimension of communication, which in this case is not restricted to technological advancements but concerns communication with ethics and as ethics, to conclude that without ethics, there is no commun...

  2. 'What is professional ethics?'.

    Science.gov (United States)

    Brecher, Bob

    2014-03-01

    The very term 'professional ethics' is puzzling with respect to what both 'professional' and 'ethics' might mean. I argue (1) that professionalism is ambiguous as to whether or not it is implicitly committed to ethical practice; (2) that to be 'professionally' ethical is at best ambiguous, if not in fact bizarre; and (3) that, taken together, these considerations suggest that professional ethics is something to be avoided rather than lauded.

  3. Ethics for life scientists

    OpenAIRE

    Korthals, M.J.J.A.A.; Bogers, R.J.

    2004-01-01

    In this book we begin with two contributions on the ethical issues of working in organizations. A fruitful side effect of this start is that it gives a good insight into business ethics, a branch of applied ethics that until now is far ahead of ethics for life scientists. In the second part, ethics of activities directly connected with doing scientific research are discussed, like experimenting with animals and human beings, publishing, patenting, getting funds and selecting one’s research th...

  4. Ethics in Management Consulting

    OpenAIRE

    Vallini, Carlo

    2007-01-01

    Ethics is a relevant value in business and management consulting. The presence of recognized ethics tends to reduce the need for informative or legal-contractual precautions in the formalization of relationships, for both of the parts involved in a negotiation. Management Consulting on ethics will develop more and more. Law will consider more and more ethics in business and management consulting. The ethics of corporations influences their workers and behaviour with the customers. It is an e...

  5. Hydrodynamic modelling in the Polish Zone of the Baltic Sea - an overview of Polish achievements

    Directory of Open Access Journals (Sweden)

    Ewa Jasińska

    2003-03-01

    Full Text Available This paper gives a general overview of Polish experience and achievements with regard to hydrodynamic modelling in the Polish zone of the Baltic Sea. The first work started already at the end of the sixties when the first 1D and 2D hydrodynamic models were set up. With the development of numerical methods and increasing computational power a number of 1D, 2D and 3D models were set up and tested. Global, regional and local models cover the most important water bodies,i.e. the Pomeranian Bay - Szczecin Lagoon and Gulf of Gdansk - Vistula Lagoon systems.

  6. Public titles of clinical trials should have ethics review.

    Science.gov (United States)

    Saenz, Carla; Reveiz, Ludovic; Tisdale, John F

    2015-09-01

    A key aspect to guarantee that research with human subjects is ethical is being overlooked. Ethics review committees invest great effort examining the informed consent documents of research protocols to ensure that potential participants can provide consent validly and are not deluded into thinking that the experimental intervention they may sign up for is already known to be therapeutic. However, these efforts to avoid what is called the "therapeutic misconception" might be in vain if the title with which the studies are being introduced to the potential participants escapes ethics review. Research participants might be deceived by clinical trials entitled "novel therapy" when the point of the trial is precisely to find out whether the intervention at stake is therapeutic or not. Providing potential research participants with such misleading information hampers their ability to make informed decisions. The well-established scrutiny that ethics review committees exercise with regard to consent forms is limited if the registration of clinical trials, for which a public title is chosen, constitutes a process that is independent from the ethics review. In this article, we examine this problem, assess recent measures to integrate clinical trial registration with ethics review processes, and provide specific recommendations to solve the problem and ultimately enhance the accountability, transparency, and ethics of research with human subjects. Copyright © 2015 Pan American Health Organization. Published by Elsevier Inc. All rights reserved.

  7. Advisory Committee Handbook.

    Science.gov (United States)

    Black Hawk Coll., Moline, IL.

    An advisory committee is generally comprised of persons outside the education profession who have specialized knowledge in a given area. The committee advises, makes recommendations, and gives service to the college and its students, instructors, and administrators. At Black Hawk College, there are four types of advisory committees: community,…

  8. Instrumental and ethical aspects of experimental research with animal models

    Directory of Open Access Journals (Sweden)

    Mirian Watanabe

    2014-02-01

    Full Text Available Experimental animal models offer possibilities of physiology knowledge, pathogenesis of disease and action of drugs that are directly related to quality nursing care. This integrative review describes the current state of the instrumental and ethical aspects of experimental research with animal models, including the main recommendations of ethics committees that focus on animal welfare and raises questions about the impact of their findings in nursing care. Data show that, in Brazil, the progress in ethics for the use of animals for scientific purposes was consolidated with Law No. 11.794/2008 establishing ethical procedures, attending health, genetic and experimental parameters. The application of ethics in handling of animals for scientific and educational purposes and obtaining consistent and quality data brings unquestionable contributions to the nurse, as they offer subsidies to relate pathophysiological mechanisms and the clinical aspect on the patient.

  9. Nurses' contributions to the resolution of ethical dilemmas in practice.

    Science.gov (United States)

    Barlow, Nichola Ann; Hargreaves, Janet; Gillibrand, Warren P

    2018-03-01

    Complex and expensive treatment options have increased the frequency and emphasis of ethical decision-making in healthcare. In order to meet these challenges effectively, we need to identify how nurses contribute the resolution of these dilemmas. To identify the values, beliefs and contextual influences that inform decision-making. To identify the contribution made by nurses in achieving the resolution of ethical dilemmas in practice. An interpretive exploratory study was undertaken, 11 registered acute care nurses working in a district general hospital in England were interviewed, using semi-structured interviews. In-depth content analysis of the data was undertaken via NVivo coding and thematic identification. Participants and context: Participants were interviewed about their contribution to the resolution of ethical dilemmas within the context of working in an acute hospital ward. Participants were recruited from all settings working with patients of any age and any diagnosis. Ethical considerations: Ethical approval was obtained from the local National Research Ethics Committee. Four major themes emerged: 'best for the patient', 'accountability', 'collaboration and conflict' and 'concern for others'. Moral distress was also evident in the literature and findings, with moral dissonance recognised and articulated by more experienced nurses. The relatively small, single-site sample may not account for the effects of organisational culture on the results; the findings suggested that professional relationships were key to resolving ethical dilemmas. Nurses use their moral reasoning based on their beliefs and values when faced with ethical dilemmas. Subsequent actions are mediated though ethical decision-making frames of reference including deontology, consequentialism, the ethics of care and virtue ethics. Nurses use these in contributing to the resolution of these dilemmas. Nurses require the skills to develop and maintain professional relationships for addressing

  10. The wear of polished and glazed zirconia against enamel.

    Science.gov (United States)

    Janyavula, Sridhar; Lawson, Nathaniel; Lawson, Nathaniel; Cakir, Deniz; Beck, Preston; Ramp, Lance C; Burgess, John O

    2013-01-01

    The wear of tooth structure opposing anatomically contoured zirconia crowns requires further investigation. The purpose of this in vitro study was to measure the roughness and wear of polished, glazed, and polished then reglazed zirconia against human enamel antagonists and compare the measurements to those of veneering porcelain and natural enamel. Zirconia specimens were divided into polished, glazed, and polished then reglazed groups (n=8). A veneering porcelain (Ceramco3) and enamel were used as controls. The surface roughness of all pretest specimens was measured. Wear testing was performed in the newly designed Alabama wear testing device. The mesiobuccal cusps of extracted molars were standardized and used as antagonists. Three-dimensional (3D) scans of the specimens and antagonists were obtained at baseline and after 200 000 and 400 000 cycles with a profilometer. The baseline scans were superimposed on the posttesting scans to determine volumetric wear. Data were analyzed with a 1-way ANOVA and Tukey Honestly Significant Difference (HSD) post hoc tests (α=.05) Surface roughness ranked in order of least rough to roughest was: polished zirconia, glazed zirconia, polished then reglazed zirconia, veneering porcelain, and enamel. For ceramic, there was no measureable loss on polished zirconia, moderate loss on the surface of enamel, and significant loss on glazed and polished then reglazed zirconia. The highest ceramic wear was exhibited by the veneering ceramic. For enamel antagonists, polished zirconia caused the least wear, and enamel caused moderate wear. Glazed and polished then reglazed zirconia showed significant opposing enamel wear, and veneering porcelain demonstrated the most. Within the limitations of the study, polished zirconia is wear-friendly to the opposing tooth. Glazed zirconia causes more material and antagonist wear than polished zirconia. The surface roughness of the zirconia aided in predicting the wear of the opposing dentition

  11. Tribological approach to study polishing of road surface under traffic

    OpenAIRE

    KANE, Malal; DO, Minh Tan

    2007-01-01

    The polishing phenomenon of road pavements under the vehicle traffic constitutes the main mechanism inherent to the loss of skid resistance over time. A better understanding of this phenomenon would allow an improvement of road safety. This study comprises a review of laboratory test and a model simulating the polishing of road surfaces. The laboratory test uses a polishing machine so called 'Wehner-Schulze' which can reproduce the evolution of the road texture from specimens taken directly f...

  12. Polish Phoneme Statistics Obtained On Large Set Of Written Texts

    Directory of Open Access Journals (Sweden)

    Bartosz Ziółko

    2009-01-01

    Full Text Available The phonetical statistics were collected from several Polish corpora. The paper is a summaryof the data which are phoneme n-grams and some phenomena in the statistics. Triphonestatistics apply context-dependent speech units which have an important role in speech recognitionsystems and were never calculated for a large set of Polish written texts. The standardphonetic alphabet for Polish, SAMPA, and methods of providing phonetic transcriptions are described.

  13. Preparing polished crystal slices with high precision orientation

    DEFF Research Database (Denmark)

    Mathiesen, S. Ipsen; Gerward, Leif; Pedersen, O.

    1974-01-01

    A polishing procedure is described which utilizes a high precision Laue technique for crystal orientation. Crystal slices with their final polished surfaces parallel to a crystallographic plane within 0.02° can be prepared. ©1974 The American Institute of Physics......A polishing procedure is described which utilizes a high precision Laue technique for crystal orientation. Crystal slices with their final polished surfaces parallel to a crystallographic plane within 0.02° can be prepared. ©1974 The American Institute of Physics...

  14. Visible Light Activated Photocatalytic Water Polishing System, Phase I

    Data.gov (United States)

    National Aeronautics and Space Administration — This proposal targets development of a LED light activated photocatalytic water polishing system that enables reduction of organic impurities (TOC and...

  15. Assessing operability of a novel polisher arrangement using MMS

    International Nuclear Information System (INIS)

    Shor, S.W.W.

    1987-01-01

    A condensate polisher is intended to remove both particulate matter and ionic material from the condensate. Condensate polishers have normally been placed directly in the condensate system downstream of the condensate pumps. This inline location has certain disadvantages. These disadvantages are discussed. Placing the polisher in a sidestream location, where water is removed from the condensate system, pumped through the polisher, and then returned to the condensate system provides a solution to these disadvantages. Several possible types of sidestream installations is described. This has a polisher taking unpolished condensate from one compartment from one compartment of a divided hotwell in a specially modified condenser and returning polished condensate to the other compartment. The polisher is supplied by its own dedicated pumps, which have a head requirement sufficient only to overcome the pressure drop through the polisher circuit at a flow rate of 110% of maximum condensate flow. This concept is very attractive but has not yet been tested even though it is being installed in several new units. A simulation was, therefore, performed using MMS to provide confidence that this particular sidestream polisher arrangement was operationally viable

  16. From Paper to Practice; Indexing Systems and Ethical Standards.

    Science.gov (United States)

    Astaneh, Behrooz; Masoumi, Sarah

    2017-04-11

    Currently one of the main goals of editors is to attain a higher visibility for their journals. On the other hand, authors strive to publish their research in journals indexed in eminent databases such as Scopus, Thompson Reuters' Web of Science (ISI), Medline, etc. Therefore, clarifying the standards of indexing is of great importance. One of the most important issues in publication is the ethical considerations, which are mainly described by organizations, such as the International Committee of Medical Journal Editors and the Committee on Publication Ethics. In this study, we examined the ethical requirements of high impact databases for indexing journals to investigate whether they mention or mandate journals to adhere to publication ethics. We found that only Scopus mandated journals to state clear ethical policies on their website as a criterion for being indexed while Medline and Directory of Open Access Journals advised journals to adhere to ethics, not mandated, and Web of Science (ISI) and PubMed Central made no mention of ethics as a required criterion for indexing. Based on this short review, there seems to be a gap between the requirements of indexing systems and international guidelines for publication ethics. Currently, most indexing systems have only partially recommended journals to consider ethical issues. In such an atmosphere, we cannot expect journals or as a result, authors to professionally, completely, and whole heartedly implement ethical guidelines as a mandatory rule in their journals and research, when the indexing systems that most editors want to be indexed in and most authors want to be cited in do not mandate such guidelines.

  17. From applied ethics to empirical ethics to contextual ethics.

    Science.gov (United States)

    Hoffmaster, Barry

    2018-02-01

    Bioethics became applied ethics when it was assimilated to moral philosophy. Because deduction is the rationality of moral philosophy, subsuming facts under moral principles to deduce conclusions about what ought to be done became the prescribed reasoning of bioethics, and bioethics became a theory comprised of moral principles. Bioethicists now realize that applied ethics is too abstract and spare to apprehend the specificity, particularity, complexity and contingency of real moral issues. Empirical ethics and contextual ethics are needed to incorporate these features into morality, not just bioethics. The relevant facts and features of problems have to be identified, investigated and framed coherently, and potential resolutions have to be constructed and assessed. Moreover, these tasks are pursued and melded within manifold contexts, for example, families, work and health care systems, as well as societal, economic, legal and political backgrounds and encompassing worldviews. This naturalist orientation and both empirical ethics and contextual ethics require judgment, but how can judgment be rational? Rationality, fortunately, is more expansive than deductive reasoning. Judgment is rational when it emanates from a rational process of deliberation, and a process of deliberation is rational when it uses the resources of non-formal reason: observation, creative construction, formal and informal reasoning methods and systematic critical assessment. Empirical ethics and contextual ethics recognize that finite, fallible human beings live in complex, dynamic, contingent worlds, and they foster creative, critical deliberation and employ non-formal reason to make rational moral judgments. © 2017 John Wiley & Sons Ltd.

  18. 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.

  19. Educating for ethical leadership.

    Science.gov (United States)

    Gallagher, Ann; Tschudin, Verena

    2010-04-01

    In this article we consider the nature of ethical leadership in nursing. An appreciation of the basis of such leadership requires an understanding of responsibility and of key intellectual and ethical qualities or virtues. We examine some of the educational and practice strategies to promote ethical leadership. We argue that there are different levels of ethical leadership. All members of the nursing workforce are ethical leaders in so far as they demonstrate a commitment to ethical practice in their everyday work and act as ethical role models for others. Nurse managers are responsible for influencing their team and for acting as arbiters between organisational and professional values. Nurse educators are role models and ethical leaders as they ensure that the explicit and hidden curriculum demonstrate a commitment to professional values. Nurses who assume political roles have an obligation to lead on ethical agenda compatible with the values of nursing.

  20. Revision of Business Ethics

    Directory of Open Access Journals (Sweden)

    Tomas Sigmund

    2011-01-01

    Full Text Available Business ethics is a controversial topic. In my article I would like to explore where the limits of business ethics are and to what extent it can become part of the economic world. I would like to explore the question what the relationship between ethics and business is and whether what business ethicists consider ethics is real ethics in the fundamental sense of the world. The concept of business ethics will be discussed compared to general ethical theories and consequences drawn. I would like to show the contradictions inherent to the connection of business and ethics are no coincidence. At the end a possible relationship between ethics and business sphere will be suggested.

  1. Relationship between ethical ideology and moral judgment: Academic nurse educators' perception.

    Science.gov (United States)

    Abou Hashish, Ebtsam Aly; Ali Awad, Nadia Hassan

    2017-01-01

    Ascertaining the relationship between ethical ideology, moral judgment, and ethical decision among academic nurse educators at work appears to be a challenge particularly in situations when they are faced with a need to solve an ethical problem and make a moral decision. This study aims to investigate the relationship between ethical ideology, moral judgment, and ethical decision as perceived by academic nurse educators. A descriptive correlational research design was conducted at Faculty of Nursing, Alexandria University. All academic nurse educators were included in the study (N = 220). Ethical Position Questionnaire and Questionnaire of Moral Judgment and Ethical Decisions were proved reliable to measure study variables. Ethical considerations: Approval was obtained from Ethics Committee at Faculty of Nursing, Alexandria University. Privacy and confidentiality of data were maintained and assured by obtaining subjects' informed consent. This study reveals a significant positive moderate correlation between idealism construct of ethical ideology and moral judgment in terms of recognition of the behavior as an ethical issue and the magnitude of emotional consequences of the ethical situation (p ethical ideology and overall moral judgment (p = 0.010). Approximately 3.5% of the explained variance of overall moral judgment is predicted by idealism together with relativism. The findings suggest that variations in ethical position and ideology are associated with moral judgment and ethical decision. Organizations of academic nursing education should provide a supportive work environment to help their academic staff to develop their self-awareness and knowledge of their ethical position and promoting their ethical ideologies and, in turn, enhance their moral judgment as well as develop ethical reasoning and decision-making capability of nursing students. More emphasis in nursing curricula is needed on ethical concepts for developing nursing competencies.

  2. Ethical Issues in Translational Research: From the Bench to Theatre

    African Journals Online (AJOL)

    undergoing randomized clinical trials (RCT) or review by research ethics committees (REC)(13). While some new surgical procedures involve a totaly new approach to the disease, some just require a change in the sequence in events during the procedure. The study by Bundi et al in the current issue raises the prospect of ...

  3. Ethical considerations in implementing a biometric co-enrolment ...

    African Journals Online (AJOL)

    The use of this web-based system to capture participant's identification details in real time was approved by the SAMRC Ethics Committee. BCEPS was implemented at 13 other research organisations conducting clinical trials in South Africa (SA). Participants who screened at the clinical research sites (CRSs) had their ...

  4. Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

    Science.gov (United States)

    Carr, Caleb T.

    2015-01-01

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

  5. Embryo politics: ethics and policy in Atlantic democracies

    National Research Council Canada - National Science Library

    Banchoff, Thomas F

    2011-01-01

    ... States, the United Kingdom, Germany, and France have grappled with these questions so far. In setting out an argument about the intersection of politics, ethics, and policy, I focus on national bioethics committees, elected leaders, and their efforts to reconcile the moral status of the embryo and the imperative of biomedical progress in practice. In order to st...

  6. Plasma electrolytic polishing of metalized carbon fibers

    Directory of Open Access Journals (Sweden)

    Falko Böttger-Hiller

    2016-02-01

    Full Text Available Efficient lightweight structures require intelligent materials that meet versatile functions. Especially, carbon-fiber-reinforced polymers (CFRPs are gaining relevance. Their increasing use aims at reducing energy consumption in many applications. CFRPs are generally very light in weight, while at the same time being extremely stiff and strong (specific strength: CFRPs: 1.3 Nm kg–1, steel: 0.27 Nm kg–1; specific stiffness: CFRPs: 100 Nm kg–1, steel: 25 Nm kg–1. To increase performance and especially functionality of CFRPs, the integration of microelectronic components into CFRP parts is aspired. The functionalization by sensors, actuators and electronics can enable a high lightweight factor and a new level of failure-safety. The integration of microelectronic components for this purpose requires a working procedure to provide electrical contacts for a reliable connection to energy supply and data interfaces. To overcome this challenge, metalized carbon fibers are used. Metalized fibers are, similar to the usual reinforcing fibers, able to be soldered and therefore easy to incorporate into CFRPs. Unfortunately, metalized fibers have to be pre-treated by flux-agents. Until now, there is no flux which is suitable for mass production without destroying the polymer of the CFRP. The process of plasma electrolytic polishing (PeP could be an option, but is so far not available for copper. Thus, in this study, plasma electrolytic polishing is transferred to copper and its alloys. To achieve this, electrolytic parameters as well as the electrical setup are adapted. It can be observed that the gloss and roughness can be adjusted by means of this procedure. Finally, plasma electrolytic polishing is used to treat thin copper layers on carbon fibers.

  7. Can an ethics officer role reduce delays in research ethics approval? A mixed-method evaluation of an improvement project

    Science.gov (United States)

    Dixon-Woods, Mary; Foy, Chris; Hayden, Charlotte; Al-Shahi Salman, Rustam; Tebbutt, Stephen; Schroter, Sara

    2016-01-01

    Objective Frustration continues to be directed at delays in gaining approvals for undertaking health research in the UK. We aimed to evaluate the impact of an ethics officer intervention on rates of favourable opinions (approval) and provisional opinions (requiring revision and resubmission) and on the time taken to reach a final opinion by research ethics committees (RECs), to characterise how the role operated in practice, and to investigate applicants' views. Design Mixed-method study involving (i) a 2-group, non-randomised before-and-after intervention study of RECs assigned an ethics officer and a matched comparator group; (ii) a process evaluation involving a survey of applicants and documentary analysis. Participants 6 RECs and 3 associated ethics officers; 18 comparator RECs; REC applicants. Results Rates of provisional and favourable opinions between ethics officer and comparator RECs did not show a statistically significant effect of the intervention (logistic regression, p=0.26 for favourable opinions and p=0.31 for provisional opinions). Mean time to reach a decision showed a non-significant reduction (ANOVA, p=0.22) from 33.3 to 32.0 days in the ethics officer RECs compared with the comparator RECs (32.6 to 32.9 days). The survey (30% response rate) indicated applicant satisfaction and also suggested that ethics officer support might be more useful before submission. Ethics officers were successful in identifying many issues with applications, but the intervention did not function exactly as designed: in 31% of applicants, no contact between the applicants and the ethics officer took place before REC review. Limitations This study was a non-randomised comparison cohort study. Some data were missing. Conclusions An ethics officer intervention, as designed and implemented in this study, did not increase the proportion of applications to RECs that were approved on first review and did not reduce the time to a committee decision. PMID:27580832

  8. Competence of Irish and Polish Teachers in the Opinions of Young Polish Immigrants in Ireland

    Science.gov (United States)

    Augustyniak, Joanna

    2016-01-01

    Since 2004, Ireland has experienced the arrival of immigrants from various countries from all over the world including Poland. The Polish came to Ireland with their families including children of school age obliged to attend compulsory education. These children have attended schools dissimilar from the ones they are accustomed to in their home…

  9. Code of ethics: principles for ethical leadership.

    Science.gov (United States)

    Flite, Cathy A; Harman, Laurinda B

    2013-01-01

    The code of ethics for a professional association incorporates values, principles, and professional standards. A review and comparative analysis of a 1934 pledge and codes of ethics from 1957, 1977, 1988, 1998, 2004, and 2011 for a health information management association was conducted. Highlights of some changes in the healthcare delivery system are identified as a general context for the codes of ethics. The codes of ethics are examined in terms of professional values and changes in the language used to express the principles of the various codes.

  10. Wind Directions in the Polish Tatras,

    Science.gov (United States)

    1982-01-26

    The study of anemometric conditions in the iatra Aoun- tains with the usually available observation data presents a rather difficult problem for two...year are presented in Table 2 and Fig. 1. Analysis of the anemometric conditions in the Polish Ta- tras and at 2odhale, on the basis of the observational...Vol. 29, 1947. 9. Milata, W. "The Foehn," Wierchy, Vol. 20, 1950. 10. Orlicz, M. " Anemometric Conditions on Peaks in the 2atras," Wiad. Sluzhby Hydro

  11. Polish students' opinion about medicinal cannabis

    OpenAIRE

    Mazur, Rafał; Masternak, Sebastian; Pająk, Michał; Parszewska, Katarzyna; Skórzyńska-Dziduszko, Katarzyna

    2017-01-01

    Mazur Rafał, Masternak Sebastian, Pająk Michał, Parszewska Katarzyna, Skórzyńska-Dziduszko Katarzyna. Polish students’ opinion about medicinal cannabis. Journal of Education, Health and Sport. 2017;7(9):233-242. eISSN 2391-8306. DOI http://dx.doi.org/10.5281/zenodo.894710 http://ojs.ukw.edu.pl/index.php/johs/article/view/4839 The journal has had 7 points in Ministry of Science and Higher Education parametric evaluation. Part B item 1223 (26....

  12. How Should Ethical Theories Be Dealt with in Engineering Ethics?

    Science.gov (United States)

    Ohishi, Toshihiro

    Contemporary engineering ethics scholars deal with contesting several ethical theories without criticizing them radically and try to use them to solve ethical problems. In this paper I first show that a conflict between ethical theories is not superficial, and pragmatic methods are adopted in engineering ethics. Second, I claim that the way to deal with contesting ethical theories in contemporary engineering ethics has an unacceptable side which does not accord with my argument that a conflict between ethical theories is not superficial and pragmatic methods are adopted in engineering ethics. Finally, I conclude that this inconsistency in contemporary engineering ethics should be corrected to make contemporary engineering ethics consistent.

  13. Biblical Ethics and Plotinus

    DEFF Research Database (Denmark)

    Pontoppidan, Maria

    2013-01-01

    This article focuses on the question of unification versus relationality in ethics. It compares two different ethical approaches from Late Antiquity, highlighting the contrast between Plotinian (Neoplatonic) ethics as striving for perfect unification of the human soul with the divinity...... - and Biblical ethics as a relational ethics, where alterity remains operative in the encounter with the deity, and where the primary ethical demand is to relate properly to fellow creatures and God as other. The latter demand is exemplified by the figure of Job, whose righteousness is interpreted as his...

  14. Recommendations of the Polish Gynecological Society concerning child sexual abuse.

    Science.gov (United States)

    Skrzypulec, Violetta; Kotarski, Jan; Drosdzol, Agnieszka; Radowicki, Stanislaw

    2010-01-01

    The World Health Organisation defines child sexual abuse as the involvement of a child in sexual activity that he or she does not fully comprehend, is unable to give informed consent to, or for which the child is not developmentally prepared and cannot give consent, or that violates the laws or social taboos of society. Child sexual abuse is evidenced by this activity between a child and an adult or another child who by age or development is in a relationship of responsibility, trust or power, the activity being intended to gratify or satisfy the needs of the other person. It is estimated that in the world on average one in 3-4 women and one in 6-10 men were victims of sexual abuse in childhood. In Poland, according to the estimates of the Child's Rights Protection Committee, approximately 20% of girls and 5-6% of boys under the age of 15 years has suffered sexual abuse. In 2007 there was an increase in violence victims in all age categories, but the most alarming data concerned minors under 13 years. Girls fall victim to sexual abuse three times more frequently than boys. Sexual abuse of boys frequently involves violence. Data show that there are fewer women than men who execute such actions against a minor. Most victims (49-84%) know the perpetrator, and approximately 14-20% of acts of violence take place within the family. This article presents recommendations of the Polish Gynecological Society concerning procedures in cases of suspected sexual abuse of children.

  15. Ethics Training in Psychiatry

    Directory of Open Access Journals (Sweden)

    Sinan Guloksuz

    2009-09-01

    Full Text Available Although ethics training is one of the core components of psychiatric education, it is not sufficiently addressed in the curricula of many educational institutions. It is shown that many of the psychiatry residents received no ethics training in both residency and medical school. Predictably, over half of the psychiatry residents had faced an ethical dilemma that they felt unprepared to meet, and nearly all of them indicated ethics education would have helped them to solve this dilemma. In addition to learning about the fundamental topics of ethics like confidentiality, boundary violations, justice, benefience and nonmaleficence, psychiatrists must also learn to deal with other hidden ethical dilemmas which are mostly due to the changing world order. It is obvious that residency training should include a well developed ethics curriculum. However, some still believe that ethical principles cannot be taught and are formed in one’s early moral development. Accepting the fact that teaching ethics is difficult, we believe that it is getting easier with the new methods for teaching in medicine. These methods are clinical supervisions, rol-models, case studies, role playing, small group discussions, team based learning and “let’s talking medicine” groups which is a useful methods for discussing ethics dilemmas on daily practice and C.A.R.E (Core Beliefs, Actions, Reasons, Experience which is a special training method for teaching ethics. In this review, the need of ethics training in residency curriculum will be discussed and new methods for teaching ethics will be proposed.

  16. Sources of bias in clinical ethics case deliberation.

    Science.gov (United States)

    Magelssen, Morten; Pedersen, Reidar; Førde, Reidun

    2014-10-01

    A central task for clinical ethics consultants and committees (CEC) is providing analysis of, and advice on, prospective or retrospective clinical cases. However, several kinds of biases may threaten the integrity, relevance or quality of the CEC's deliberation. Bias should be identified and, if possible, reduced or counteracted. This paper provides a systematic classification of kinds of bias that may be present in a CEC's case deliberation. Six kinds of bias are discussed, with examples, as to their significance and risk factors. Possible remedies are suggested. The potential for bias is greater when the case deliberation is performed by an individual ethics consultant than when an entire clinical ethics committee is involved. 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.

  17. Evaluation of School of health students' ethics position in Turkey.

    Science.gov (United States)

    Şen, Emine; Dal, Nursel Alp; Üstün, Çağatay; Okursoy, Algın

    2017-03-01

    The advances in science and technology increasingly lead to the appearance of ethical issues and to the complexity of care. Therefore, it is important to define the ethics position of students studying in health departments so that high quality patient care can be achieved. The aim of this study was to examine the ethics position of the students at Shool of Health of an University in western Turkey. The study design was descriptive and cross-sectional. The study population included 540 first, second, third, and fourth year students from the Departments of Nursing, Midwifery, and Rescue and Disaster Management in the 2013-2014 academic year. Data were collected with a Personal Identification Form and The Ethics Position Questionnaire. Obtained data were analyzed with Chi-square test, Confirmatory Factor Analysis, and Nested Analysis of Variance. Ethical considerations: Before conducting the research, approval was obtained from Ege University Clinical Research Ethics Committee in İzmir and written informed consent was taken from all the participants. There was no significant difference in the mean scores for the Ethics Position Questionnaire between the students in terms of years and fields of study. Although the mean scores for the subscale idealism did not differ between fields of study, the mean scores significantly differed between years of study. However, the mean scores for the subscale relativism did not differ in terms of years and fields of study. Whether students are idealistic or relativistic in terms of ethical judgment will be effective in ethical decision-making skills during patient care. Therefore, we need to define the factors that influence students' ethics position in the future. It is suggested that the courses and practices that teach students to be aware of their ethics position to create an ethical outlook can be placed in the curriculum in health schools.

  18. The Evaluation of Efficiency of Polish Agriculture

    Directory of Open Access Journals (Sweden)

    Piotr Bórawski

    2015-01-01

    Full Text Available The objective of the paper was to recognize the efficiency of Polish agriculture. We have studied data from Main Statistical Office (MSO and compared the efficiency in the years 2000–2010. The data proved that the efficiency of Polish agriculture improved in the analyzed period. To measure the impact of macroeconomic variables we introduced these into the regression model. The macroeconomic factors included: X1 (nominal prices of land, X2 (land prices expressed in dt, X3 (inflation, X4 (investment in agriculture and hunting, X5 (balance of trade and X6 (GDP. We wanted to recognize the impact of macroeconomic factors on: Y1 (gross output, Y2 (intermediate consumption, Y3 (gross value added. Multiple regression was used to measure the impact of macroeconomic factors on global production of agriculture. The strongest impact on gross value added had: X4 (investment in agriculture and horticulture and X4 (trade balance. Poland is a member of European Union and the Common Agricultural Policy has improved the situation in agriculture. There are about 2 100 000 farms in Poland but only 300 000–400 000 are producing for the market. Other farms have social functions and are place for work for rural inhabitants.

  19. Food patterns of Polish older people

    DEFF Research Database (Denmark)

    Wadolowska, L.; Danowska-Oziewicz, M.; Niedzwiedzka, E.

    2006-01-01

    Food patterns of Polish older people were separated and described. The research included 422 people aged 65+ years, living in 5 geographical locations. Participants of the study were selected in quota sampling. Criteria for recruitment included sex, age (65-^74 or 75+ years) and family status (li...... and small number of products fonning joint food patterns speak in advocacy of relatively small reciprocal relationship between different food items consumed by the seniors in Poland.......Food patterns of Polish older people were separated and described. The research included 422 people aged 65+ years, living in 5 geographical locations. Participants of the study were selected in quota sampling. Criteria for recruitment included sex, age (65-^74 or 75+ years) and family status...... (living alone or living with other people). Respondents were asked questions about consumption of 55 food products. The factor analysis allowed for separating 21 food patterns. They included from 1 to 3 groups of products, intake of which was mutually dependant. Big number of separated food patterns...

  20. Farmers' pensions and the Polish economic crisis.

    Science.gov (United States)

    Simanis, J G

    1983-04-01

    The Polish Government, in 1977, inaugurated a new pension program that made old-age and invalidity benefits available for the first time to most farmers in that country. The evolution and eventual failure of that program were closely intertwined with a growing national economic crisis, manifested in widespread popular unrest and culminating in emergence of the Solidarity movement. The farmers' pension program was originally presented as both a social security measure and a vehicle for improving agricultural efficiency. The economic situation was expected to benefit as farms of older owners were passed to younger, presumably more efficient, successors, with the state sometimes acting as intermediary. A further step to bind the social security concept to agricultural efficiency came through relating the pension amount to the quantity of produce the individual farmer sold to the state over a number of years. The failure of these provisions and other unpopular features of the new program was aggravated by inflation and continuing deterioration of the Polish economy.