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Sample records for ethics review board

  1. Balanced Ethics Review: A Guide for Institutional Review Board Members

    Directory of Open Access Journals (Sweden)

    Ames Dhai

    2016-12-01

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

  2. Research Ethics: Institutional Review Board Oversight of Art Therapy Research

    Science.gov (United States)

    Deaver, Sarah P.

    2011-01-01

    By having their research proposals reviewed and approved by Institutional Review Boards (IRBs), art therapists meet important ethical principles regarding responsibility to research participants. This article provides an overview of the history of human subjects protections in the United States; underlying ethical principles and their application…

  3. Is mandatory research ethics reviewing ethical?

    Science.gov (United States)

    Dyck, Murray; Allen, Gary

    2013-08-01

    Review boards responsible for vetting the ethical conduct of research have been criticised for their costliness, unreliability and inappropriate standards when evaluating some non-medical research, but the basic value of mandatory ethical review has not been questioned. When the standards that review boards use to evaluate research proposals are applied to review board practices, it is clear that review boards do not respect researchers or each other, lack merit and integrity, are not just and are not beneficent. The few benefits of mandatory ethical review come at a much greater, but mainly hidden, social cost. It is time that responsibility for the ethical conduct of research is clearly transferred to researchers, except possibly in that small proportion of cases where prospective research participants may be so intrinsically vulnerable that their well-being may need to be overseen.

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

    Science.gov (United States)

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

    2007-07-01

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

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

    Science.gov (United States)

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

    2007-01-01

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

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

    Science.gov (United States)

    Bozeman, Barry; Slade, Catherine; Hirsch, Paul

    2009-09-01

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

  8. 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.

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

    Science.gov (United States)

    Knopman, David; Alford, Eli; Tate, Kaitlin; Long, Mark; Khachaturian, Ara S

    2017-08-01

    For nearly 50 years, institutional review boards (IRB) and independent ethics committees have featured local oversight as a core function of research ethics reviews. However growing complexity in Alzheimer's clinical research suggests current approaches to research volunteer safety is hampering development of new therapeutics. As a partial response to this challenge, the NIH has mandated that all NIH-funded multi-site studies will use a single Institutional Review Board. The perspective describes a joint program to provide a single IRB of record (sIRB) for phases of multi-site studies. The approach follows two steps. One, an expert Scientific Review Committee (SRC) of senior researchers in the field will conduct the review principally of scientific merit, significance, feasibility, and the likelihood of meaningful results. The second step will be the IRB's regulatory and ethics review. The IRB will apply appropriate regulatory criteria for approval including minimization of risks to subjects and risks reasonable in relation to anticipated benefits, equitable subject selection, informed consent, protections for vulnerable populations, and application of local context considerations, among others. There is a steady demand for scientific, ethical and regulatory review of planned Alzheimer's studies. As of January 15, 2017, there are nearly 400 open studies, Phase II and III, industry and NIH sponsored trials on disease indications affecting memory, movement and mood in the US. The effort will initially accept protocols for studies of Alzheimer's disease, dementia, and related disorders effecting memory, movement and mood. Future aims will be to provide scientific review and, where applicable, regulatory and ethical review in an international context outside North America with sites possibly in Asia, Europe and Australia. Copyright © 2017 the Alzheimer's Association. Published by Elsevier Inc. All rights reserved.

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

    Directory of Open Access Journals (Sweden)

    Roger A. Barker

    2018-05-01

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

  11. Participatory action research: considerations for ethical review.

    Science.gov (United States)

    Khanlou, N; Peter, E

    2005-05-01

    This paper addresses the distinctive nature of participatory action research (PAR) in relation to ethical review requirements. As a framework for conducting research and reducing health disparities, PAR is gaining increased attention in community and public health research. As a result, PAR researchers and members of Research Ethics Boards could benefit from an increased understanding of the array of ethical concerns that can arise. We discuss these concerns in light of commonly held ethical requirements for clinical research (social or scientific value, scientific validity, fair subject/participant selection, favourable risk-benefit ratio, independent review, informed consent, and respect for potential and enrolled participants) and refer to guidelines specifically developed for participatory research in health promotion. We draw from our community-based experiences in mental health promotion research with immigrant and culturally diverse youth to illustrate the ethical advantages and challenges of applying a PAR approach. We conclude with process suggestions for Research Ethics Boards.

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

    Science.gov (United States)

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

    2013-12-01

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

  13. Ethical review in Pakistan: the credibility gap.

    Science.gov (United States)

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

    2012-12-01

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

  14. 77 FR 64521 - Updated OGE Senior Executive Service Performance Review Board

    Science.gov (United States)

    2012-10-22

    ... Ethics, Environmental Protection Agency; Melinda Loftin, Director of Interior Ethics Office, Department... OFFICE OF GOVERNMENT ETHICS Updated OGE Senior Executive Service Performance Review Board AGENCY: Office of Government Ethics (OGE). ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of...

  15. 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…

  16. [Reporting ethics board approval in German medical theses and journals].

    Science.gov (United States)

    Zenz, Michael; Zenz, Julia; Grieger, Maximilian

    2018-06-05

    Since 1975, the Declaration of Helsinki of the World Medical Association (WMA) has clearly required ethics committee approval for research into humans. Nevertheless, this Declaration is violated quite often. As many English-language publications have addressed the theme of ethics board approval in theses and other published works, it is now to be investigated in Germany for the first time.From 2013 to 2014, a total of 1,482 medical theses at four selected universities in addition to three German-language scientific journals were reviewed. In 543 theses, reference to ethics approval would have been required according to the criteria of the Declaration of Helsinki.However, ethics approval was stated in only 58.7% of cases, and even less frequently if the prevailing doctoral regulations or instructions did not refer to the necessity of obtaining ethics approval. Theses on pediatrics mentioned ethics approval most frequently (78.6%), whereas the proportion of surgical papers was the lowest (34.9%). Among the journals, Der Nervenarzt mentioned ethics approval most frequently (59.4%) and Der Chirurg least frequently (30%).Our results point to significant deficits in mentioning ethics approval in medical theses and publications. These deficits could easily be compensated for by a thorough approach of the referees of doctoral regulations and by journal reviewers and editors.

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

    Science.gov (United States)

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

    2016-01-01

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

  18. Resources for Governing Board on Codes of Ethics

    Science.gov (United States)

    Community College League of California, 2009

    2009-01-01

    Reprinted herein is Chapter 14 of the "2007 Trustee Handbook," published by the Community College League of California. Contents include: (1) Ethics and Laws; (2) Sample Statements: Codes of Ethics and Standards for Practice; (3) Association of Community College Trustees Models; and (4) Upholding Board Ethics.

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

    Directory of Open Access Journals (Sweden)

    Ignacio Segarra

    2017-07-01

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

  20. Tiny tweaks, big changes: An alternative strategy to empower ethical culture of human research in anesthesia (A Taiwan Acta Anesthesiologica Taiwanica-Ethics Review Task Force Report).

    Science.gov (United States)

    Luk, Hsiang-Ning; Ennever, John F; Day, Yuan-Ji; Wong, Chih-Shung; Sun, Wei-Zen

    2015-03-01

    For this guidance article, the Ethics Review Task Force (ERTF) of the Journal reviewed and discussed the ethics issues related to publication of human research in the field of anesthesia. ERTF first introduced international ethics principles and minimal requirements of reporting of ethics practices, followed by discussing the universal problems of publication ethics. ERTF then compared the accountability and methodology of several medical journals in assuring authors' ethics compliance. Using the Taiwan Institutional Review Board system as an example, ERTF expressed the importance of institutional review board registration and accreditation to assure human participant protection. ERTF presented four major human research misconducts in the field of anesthesia in recent years. ERTF finally proposed a flow-chart to guide journal peer reviewers and editors in ethics review during the editorial process in publishing. Examples of template languages applied in the Ethics statement section in the manuscript are expected to strengthen the ethics compliance of the authors and to set an ethical culture for all the stakeholders involved in human research. Copyright © 2015. Published by Elsevier B.V.

  1. The Satisfaction and Use of Research Ethics Board Information Systems in Canada.

    Science.gov (United States)

    Detlor, Brian; Wilson, Michael J

    2015-10-01

    This article reports findings from a national survey of Research Ethics Board (REB) personnel across Canada on the satisfaction and use of information systems that support the review and administration of research ethics protocols. Findings indicate that though a wide variety of REB systems are utilized, the majority fall short of desired characteristics. Despite these shortcomings, most respondents are satisfied with their current REB systems. Satisfaction is dependent on the volume of protocols processed in relation to the robustness of the system. Boards with higher volumes are more satisfied with full-fledged systems; however, the satisfaction of REBs with lower volumes is not affected by the robustness of the REB system used. Recommendations are provided. © The Author(s) 2015.

  2. Institutional Review Boards: Perspectives from the United States

    Directory of Open Access Journals (Sweden)

    Alvita Nathaniel, Ph.D., FNP-BC, FAANP

    2010-12-01

    Full Text Available In the U.S., all research must be approved by an Institutional Review Board (IRB that evaluates research protocols for the purpose of protecting human subjects. This paper includes a brief history of the development of public policy that guides institutional review boards in the U.S. and commentary on the responsibilities of a grounded theory researcher interested in applying for approval for a research study.An institutional review board (IRB is a formally constituted committee that approves and monitors biomedical and behavioural research with the purpose of protecting the rights and welfare of research participants. An IRB performs scientific, ethical, and regulatory oversight functions. In the U.S., it is common for grounded theorists to experience frustration with the IRB protocol submission process. Facets of the application process may seem rigid, redundant, and non-applicable. Review board members may not seem to understand or appreciate qualitative methods and delays are common. In addition, a conglomeration of disparate policies and procedures coupled with a variety of types of review boards creates a system that defies description. Nevertheless, a researcher who understands public policy and the responsibilities of institutional review boards can learn to develop research applications that are quickly approved.

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

    Science.gov (United States)

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

    2016-04-01

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

  4. 75 FR 10261 - Request for Nominations to the EPA Human Studies Review Board

    Science.gov (United States)

    2010-03-05

    ... scientific and ethical aspects of human subjects research. The major objectives of the HSRB are to provide... of the following areas: Bioethics: expertise in the ethics of research with human subjects... EPA Human Studies Review Board AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY...

  5. Institutional review board and regulatory solutions in the dental PBRN

    DEFF Research Database (Denmark)

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

    2010-01-01

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

  6. 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.

  7. Institutional review boards' attitudes towards remuneration in paediatric research

    DEFF Research Database (Denmark)

    Flege, Marius M; Thomsen, Simon F

    2017-01-01

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

  8. 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...

  9. 76 FR 17121 - Human Studies Review Board (HSRB); Notification of a Public Meeting

    Science.gov (United States)

    2011-03-28

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0124; FRL-9287-1] Human Studies Review Board (HSRB); Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice... public meeting of the HSRB to advise the Agency on EPA's scientific and ethical reviews of research with...

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

    Directory of Open Access Journals (Sweden)

    Klaus Rose

    2015-05-01

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

  11. The job of 'ethics committees'.

    Science.gov (United States)

    Moore, Andrew; Donnelly, Andrew

    2015-11-13

    What should authorities establish as the job of ethics committees and review boards? Two answers are: (1) review of proposals for consistency with the duly established and applicable code and (2) review of proposals for ethical acceptability. The present paper argues that these two jobs come apart in principle and in practice. On grounds of practicality, publicity and separation of powers, it argues that the relevant authorities do better to establish code-consistency review and not ethics-consistency review. It also rebuts bad code and independence arguments for the opposite view. It then argues that authorities at present variously specify both code-consistency and ethics-consistency jobs, but most are also unclear on this issue. The paper then argues that they should reform the job of review boards and ethics committees, by clearly establishing code-consistency review and disestablishing ethics-consistency review, and through related reform of the basic orientation, focus, name, and expertise profile of these bodies and their actions. 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. Qualitative research ethics on the spot

    DEFF Research Database (Denmark)

    Sørensen, Nelli Øvre; Øye, Christine; Glasdam, Stinne

    2015-01-01

    Abstract Background: The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Method: Based on three different cases from three different research studies...... research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Discussion and conclusion: Research...... ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop....

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

    Directory of Open Access Journals (Sweden)

    Rudel Ruthann A

    2010-07-01

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

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

    Science.gov (United States)

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

    2018-05-08

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

  15. A Swedish perspective on research ethics review

    Directory of Open Access Journals (Sweden)

    Hans Thulesius, M.D., G.P., Ph.D.

    2010-12-01

    Full Text Available I have participated in writing ethical approval applications for research projects in Sweden a dozen times. I am also since some years a member of the local ethics advisory board in a mostly rural area serving 180.000 people. From that position I advise on what types of local project applications will have to be sent further to the regional ethics committee, REPN in Sweden. With that background I will try to give a brief Swedish perspective on research ethics reviews in general and regarding CGT (classic grounded theory studies using qualitative data in particular.The most famous Swedish example of unethical research is the 1947-1951 Vipeholm sugar trial (Krasse, 2001. Several hundred intellectually and mentally challenged persons at the Vipeholm institution were for years given an excess amount of sugar, mostly in the shape of candy. This resulted in caries that totally ruined the teeth of 50 persons. Of course participants did not give informed consent. Yet, at the time the research was not considered unethical. At least there was no debate about it.

  16. Justification and authority in institutional review board decision letters.

    Science.gov (United States)

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

    2017-12-01

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

  17. Analysis of research ethics board approval times in an academic department of medicine.

    Science.gov (United States)

    Tsang, Teresa S M; Jones, Meaghan; Meneilly, Graydon S

    2015-04-01

    As part of an ongoing effort to better understand barriers to academic research, we reviewed and analyzed the process of research ethics applications, focusing on ethics approval time, within the Department of Medicine from 2006 to 2011. A total of 1,268 applications for approval to use human subjects in research were included in our analysis. Three variables, risk category (minimal vs. non-minimal risk), type of funding, and year of submission, were statistically significant for prediction of ethics approval time, with risk status being the most important of these. The covariate-adjusted mean time for approval for minimal risk studies (35.7 days) was less than half that of non-minimal risk protocols (76.5 days). Studies funded through a for-profit sponsor had significantly longer approval times than those funded through other means but were also predominantly (87%) non-minimal risk protocols. Further investigations of the reasons underlying the observed differences are needed to determine whether improved training for research ethics board (REB) members and/or greater dialogue with investigators may reduce the lengthy approval times associated with non-minimal risk protocols. © The Author(s) 2015.

  18. 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.

  19. 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......? Drawing on ethnographic fieldwork with the Forum of Ethics Review Committees of Asia and the Pacific (FERCAP), a capacity-building NGO that runs ethics committee trainings and reviews in the Asia Pacific region, I develop an analysis of ethical review and its effects. I focus on a ‘second-order audit’ run...... readings of ‘ethics’. I begin and end with a reflection on the ethical effects of a measurement practice that takes ethics itself as its object....

  20. The interactions of Canadian ethics consultants with health care managers and governing boards during times of crisis.

    Science.gov (United States)

    Kaposy, Chris; Maddalena, Victor; Brunger, Fern; Pullman, Daryl; Singleton, Richard

    2017-01-01

    Health care organizations can be very complex, and are often the setting for crisis situations. In recent years, Canadian health care organizations have faced large-scale systemic medical errors, a nation-wide generic injectable drug shortage, iatrogenic infectious disease outbreaks, and myriad other crises. These situations often have an ethical component that ethics consultants may be able to address. Organizational leaders such as health care managers and governing boards have responsibilities to oversee and direct the response to crisis situations. This study investigates the nature and degree of involvement of Canadian ethics consultants in such situations. This qualitative study used semi-structured interviews with Canadian ethics consultants to investigate the nature of their interactions with upper-level managers and governing board members in health care organizations, particularly in times of organizational crisis. We used a purposive sampling technique to identify and recruit ethics consultants throughout Canada. We found variability in the interactions between ethics consultants and upper-level managers and governing boards. Some ethics consultants we interviewed did not participate in managing organizational crisis situations. Most ethics consultants reported that they had assisted in the management of some crises and that their participation was usually initiated by managers. Some ethics consultants reported the ability to bring issues to the attention of upper-level managers and indirectly to their governing boards. The interactions between managers and ethics consultants were characterized by varying degrees of collegiality. Ethics consultants reported participating in or chairing working groups, participating in incident management teams, and developing decision-making frameworks. Canadian ethics consultants tend to believe that they have valuable skills to offer in the management of organizational crisis situations. Most of the ethics consultants

  1. Need for ethics support in healthcare institutions: views of Dutch board members and ethics support staff.

    Science.gov (United States)

    Dauwerse, Linda; Abma, Tineke; Molewijk, Bert; Widdershoven, Guy

    2011-08-01

    The purpose of this article is to investigate the need for ethics support in Dutch healthcare institutions in order to understand why ethics support is often not used in practice and which factors are relevant in this context. This study had a mixed methods design integrating quantitative and qualitative research methods. Two survey questionnaires, two focus groups and 17 interviews were conducted among board members and ethics support staff in Dutch healthcare institutions. Most respondents see a need for ethics support. This need is related to the complexity of contemporary healthcare, the contribution of ethics support to the core business of the organisation and to the surplus value of paying structural attention to ethical issues. The need for ethics support is, however, not unconditional. Reasons for a lacking need include: aversion of innovations, negative associations with the notion of ethics support service, and organisational factors like resources and setting. There is a conditioned need for ethics support in Dutch healthcare institutions. The promotion of ethics support in healthcare can be fostered by focusing on formats which fit the needs of (practitioners in) healthcare institutions. The emphasis should be on creating a (culture of) dialogue about the complex situations which emerge daily in contemporary healthcare practice.

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

    Directory of Open Access Journals (Sweden)

    von Dadelszen Peter

    2010-07-01

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

  3. Working with the institutional review board.

    Science.gov (United States)

    Byerly, Wesley G

    2009-01-15

    Working with an institutional review board (IRB) to ensure compliance and ethical conduct of research involving human subjects is discussed. The Department of Health and Human Services (DHHS) and Food and Drug Administration regulations for the conduct of human research are grounded in the principles of the Belmont Report. By establishing the requirements for the function and operation of the IRB, the criteria needed for the review and approval of research, and the requirements for obtaining and documenting informed consent, the federal regulations help ensure the safety, rights and welfare of subjects. In developing research protocols and submissions to the IRB, the investigator should include clear, detailed information that addresses the regulatory requirements for the review and approval of research. Before starting a research study, review and approval by the IRB is required unless the study is determined to be minimal risk and fits one of the defined categories. Some research projects involving observation of public behavior, collection of anonymous surveys of nonvulnerable individuals in which the information is not considered sensitive, and evaluation of standard education practices may be exempt from DHHS regulations. Informed consent is central to the protection of human subjects and is required unless the IRB allows a waiver or alteration of informed consent. Once the study is approved, the investigator must conduct the study as approved by the IRB and continue to meet the regulatory requirements related to modifications, reporting unanticipated events, and continuing review. IRB review is integral to ensuring regulatory compliance and ethical conduct of research involving human subjects. Working closely with the IRB or colleagues who have had experience with the IRB will help junior investigators better understand the IRB submission and review process.

  4. Computerized information management for institutional review boards.

    Science.gov (United States)

    Hood, Maureen N; Gugerty, Brian; Levine, Richard; Ho, Vincent B

    2005-01-01

    The use of human subjects for medical research in most industrialized nations requires the scientific and ethical scrutiny of research proposals by a governing institutional review board (IRB) or its equivalent. As part of their primary charge to protect human subjects, IRBs are responsible for the regulatory oversight of not only the research protocol itself but also the research conduct of the investigators and, if applicable, the funding sponsor. This article will discuss the regulatory requirements for an accurate account of IRB protocols and investigators and present an overview of the general flow of information for an IRB protocol. The current and potential uses of information management systems by IRBs will also be reviewed and accompanied by a discussion of the potential advantages and disadvantages of various computerized information systems for management of clinical research.

  5. Research Ethics: Reforming Postgraduate Formation

    Science.gov (United States)

    Vallance, Roger J.

    2005-01-01

    Research ethics is not only a matter of doing no harm, or even abiding by the guidelines of the Ethics Review Board of the institution. While these matters are important and legal requirements, there is much more at stake in discussions of research ethics. Research ethics establish the foundation upon which research rests. Taking the social…

  6. Research ethics board approval for an international thromboprophylaxis trial.

    Science.gov (United States)

    Lutz, Kristina; Wilton, Kelly; Zytaruk, Nicole; Julien, Lisa; Hall, Richard; Harvey, Johanne; Skrobik, Yoanna; Vlahakis, Nicholas; Meade, Laurie; Matte, Andrea; Meade, Maureen; Burns, Karen; Albert, Martin; Cash, Bronwyn Barlow; Vallance, Shirley; Klinger, James; Heels-Ansdell, Diane; Cook, Deborah

    2012-06-01

    Research ethics board (REB) review of scientific protocols is essential, ensuring participants' dignity, safety, and rights. The objectives of this study were to examine the time from submission to approval, to analyze predictors of approval time, and to describe the scope of conditions from REBs evaluating an international thromboprophylaxis trial. We generated survey items through literature review and investigators' discussions, creating 4 domains: respondent and institutional demographics, the REB application process, and alternate consent models. We conducted a document analysis that involved duplicate assessment of themes from REB critique of the protocol and informed consent forms (ICF). Approval was granted from 65 REB institutions, requiring 58 unique applications. We analyzed 44 (75.9%) of 58 documents and surveys. Survey respondents completing the applications had 8 (5-12) years of experience; 77% completed 4 or more REB applications in previous 5 years. Critical care personnel were represented on 54% of REBs. The time to approval was a median (interquartile range) of 75 (42, 150) days, taking longer for sites with national research consortium membership (89.1 vs 31.0 days, P = .03). Document analysis of the application process and ICF yielded 5 themes: methodology, data management, consent procedures, cataloguing, and miscellaneous. Protocol-specific themes focused on trial implementation, external critiques, and budget. The only theme specific to the ICF was risks and benefits. The most frequent comments on the protocol and ICF were about methodology and miscellaneous issues; ICF comments also addressed study risks and benefits. More studies on methods to enhance efficiency and consistency of the REB approval processes for clinical trials are needed while still maintaining high ethical standards. Copyright © 2012 Elsevier Inc. All rights reserved.

  7. Ethics Review of Pediatric Multi-Center Drug Trials

    NARCIS (Netherlands)

    Needham, Allison C.; Kapadia, Mufiza Z.; Offringa, Martin

    2015-01-01

    The assessment of safety and efficacy of therapeutics for children and adolescents requires the use of multi-centered designs. However, the need to obtain ethical approval from multiple independent research ethics boards (REBs) presents as a challenge to investigators and sponsors who must consider

  8. Failure to report and provide commentary on research ethics board approval and informed consent in medical journals.

    Science.gov (United States)

    Finlay, K A; Fernandez, C V

    2008-10-01

    The Declaration of Helsinki prohibits the publication of articles that do not meet defined ethical standards for reporting of research ethics board (REB) approval and informed consent. Despite this prohibition and a call to highlight the deficiency for the reader, articles with potential ethical shortcomings continue to be published. To determine what proportion of articles in major medical journals lack statements confirming REB approval and informed consent, and whether accompanying commentary alerts readers to this deficiency. Retrospective, observational study. Online review of five major medical journals. All clinical research articles published online between 1 January 2005 and 31 December 2006 in the BMJ, Lancet, Annals of Internal Medicine, JAMA and the New England Journal of Medicine. Statement of REB approval and informed consent. Of 1780 articles reviewed, 1133 (63.7%) met inclusion criteria (manuscripts reporting human subjects, human tissue or identifiable personal data research), 36 (3.2%) articles lacked a statement of REB approval, 62 (5.5%) lacked disclosure of informed consent and 15 (1.3%) articles lacked both. Articles that did not state REB approval were associated with not stating informed consent (pjournals without editorial statements to alert the reader to this deficiency.

  9. Ethics and privacy issues of a practice-based surveillance system: need for a national-level institutional research ethics board and consent standards.

    Science.gov (United States)

    Kotecha, Jyoti A; Manca, Donna; Lambert-Lanning, Anita; Keshavjee, Karim; Drummond, Neil; Godwin, Marshall; Greiver, Michelle; Putnam, Wayne; Lussier, Marie-Thérèse; Birtwhistle, Richard

    2011-10-01

    To describe the challenges the Canadian Primary Care Sentinel Surveillance Network (CPCSSN) experienced with institutional research ethics boards (IREBs) when seeking approvals across jurisdictions and to provide recommendations for overcoming challenges of ethical review for multisite and multijurisdictional surveillance and research. The CPCSSN project collects and validates longitudinal primary care health information (relating to hypertension, diabetes, depression, chronic obstructive lung disease, and osteoarthritis) from electronic medical records across Canada. Privacy and data storage security policies and processes have been developed to protect participants' privacy and confidentiality, and IREB approval is obtained in each participating jurisdiction. Inconsistent interpretation and application of privacy and ethical issues by IREBs delays and impedes research programs that could better inform us about chronic disease. The CPCSSN project's experience with gaining approval from IREBs highlights the difficulty of conducting pan-Canadian health surveillance and multicentre research. Inconsistent IREB approvals to waive explicit individual informed consent produced particular challenges for researchers. The CPCSSN experience highlights the need to develop a better process for researchers to obtain timely and consistent IREB approvals for multicentre surveillance and research. We suggest developing a specialized, national, centralized IREB responsible for approving multisite studies related to population health research.

  10. 78 FR 66384 - Membership of the Merit Systems Protection Board's Performance Review Board

    Science.gov (United States)

    2013-11-05

    ... MERIT SYSTEMS PROTECTION BOARD Membership of the Merit Systems Protection Board's Performance Review Board AGENCY: Merit Systems Protection Board. ACTION: Notice. SUMMARY: Notice is hereby given of the members of the Merit Systems Protection Board's Performance Review Board. DATES: November 5, 2013...

  11. ASSESSMENT OF THE ETHICAL ASPECTS OF BOARDS DENTIST IN JEQUIÉ-BA

    Directory of Open Access Journals (Sweden)

    Iane Souza Nery Silva

    2012-09-01

    Full Text Available The objective consisted in the evaluation of ethical violations present on the boards of dental clinics in the city of Jequié, according to CFO-Resolution 71 of 2006. Dental advertising boards were photographed, both laid down in front of the doctor's offices and clinics, and the advertising that made these. The photographs were examined by four judges, with use of a computer, whereas as must haves for the presence of the name and the registration number in the CRO and representative name of the profession of dental surgeon; optional items were the presence of areas of practice, if there is this inscription in CRO, academic qualifications, address, telephone number, fax number, e-mail address, work schedule, covenants, accreditations and the term general practitioner; and the items are price, listing offenders free services, payment arrangements, grooming of patients and artifices of Avaliação ética das placas odontológicas advertisement to gain customers. It was found that only ads and plaques were 11,76% the must haves, 88,24% contained optional items and 11,76% were in disagreement with any item of Dental Ethics Code considered as infringement. It can be concluded that most of the advertisements was not collected in accordance to the current legislation, since in addition to ethical violations have plates 11,76%, 88,24% lacked all items considered mandatory.

  12. Ethical challenges for accountable care organizations: a structured review.

    Science.gov (United States)

    DeCamp, Matthew; Farber, Neil J; Torke, Alexia M; George, Maura; Berger, Zackary; Keirns, Carla C; Kaldjian, Lauris C

    2014-10-01

    Accountable care organizations (ACOs) are proliferating as a solution to the cost crisis in American health care, and already involve as many as 31 million patients. ACOs hold clinicians, group practices, and in many circumstances hospitals financially accountable for reducing expenditures and improving their patients' health outcomes. The structure of health care affects the ethical issues arising in the practice of medicine; therefore, like all health care organizational structures, ACOs will experience ethical challenges. No framework exists to assist key ACO stakeholders in identifying or managing these challenges. We conducted a structured review of the medical ACO literature using qualitative content analysis to inform identification of ethical challenges for ACOs. Our analysis found infrequent discussion of ethics as an explicit concern for ACOs. Nonetheless, we identified nine critical ethical challenges, often described in other terms, for ACO stakeholders. Leaders could face challenges regarding fair resource allocation (e.g., about fairly using ACOs' shared savings), protection of professionals' ethical obligations (especially related to the design of financial incentives), and development of fair decision processes (e.g., ensuring that beneficiary representatives on the ACO board truly represent the ACO's patients). Clinicians could perceive threats to their professional autonomy (e.g., through cost control measures), a sense of dual or conflicted responsibility to their patients and the ACO, or competition with other clinicians. For patients, critical ethical challenges will include protecting their autonomy, ensuring privacy and confidentiality, and effectively engaging them with the ACO. ACOs are not inherently more or less "ethical" than other health care payment models, such as fee-for-service or pure capitation. ACOs' nascent development and flexibility in design, however, present a time-sensitive opportunity to ensure their ethical operation

  13. [Responsibilities of ethics committees].

    Science.gov (United States)

    von Bergmann, K

    2000-05-01

    Increasing numbers of clinical research projects are submitted to ethical committees (institutional review boards) for approval. New therapeutic developments have to be evaluated by these committees to protect patients/volunteers. Thus, the responsibility of ethical committees is increasing. The "Nürnberger Kodex" and the "Declaration of Helsinki" are the background for these evaluations. According to the German drug law the physician is obligated by law to submit the protocol to such a committee. In addition, local state physician authorities require such a procedure. Important considerations during the review process besides ethical aspects are the informed consent, which should be written in an understandable form, and the obligations of the insurance.

  14. Qualitative research ethics on the spot: Not only on the desktop.

    Science.gov (United States)

    Øye, Christine; Sørensen, Nelli Øvre; Glasdam, Stinne

    2016-06-01

    The increase in medical ethical regulations and bureaucracy handled by institutional review boards and healthcare institutions puts the researchers using qualitative methods in a challenging position. Based on three different cases from three different research studies, the article explores and discusses research ethical dilemmas. First, and especially, the article addresses the challenges for gatekeepers who influence the informant's decisions to participate in research. Second, the article addresses the challenges in following research ethical guidelines related to informed consent and doing no harm. Third, the article argues for the importance of having research ethical guidelines and review boards to question and discuss the possible ethical dilemmas that occur in qualitative research. Research ethics must be understood in qualitative research as relational, situational, and emerging. That is, that focus on ethical issues and dilemmas has to be paid attention on the spot and not only at the desktop. © The Author(s) 2015.

  15. Ethics in research.

    Science.gov (United States)

    Bevan, Joan C

    2007-04-01

    This review will examine research ethics in the context of globalization of clinical trials and recent rapid developments in bioscience. It will focus on international ethical guidelines and the functions of research ethics review boards in research governance. Consent issues in genetic research, which must comply with privacy laws by protecting confidentiality and privacy of personal health data, will be discussed. There has been a rapid expansion of genomic and proteonomic research and biotechnology in the last decade. International ethical guidelines have been updated and the bioscience industry has developed ethics policies. At the same time, problems in academic anesthesia in the US and UK have been identified, leading to recommendations to train physician-scientists in anesthesia to stimulate research activity in the future. Anesthesiologists are joining interdisciplinary research teams and the concept of evidence-based translational research is emerging. Anesthesiologists are moving towards participation in interdisciplinary research teams. They are well placed to speed the translation of research discovery into clinical practice and provide evidence-based perioperative care. This review provides the ethical framework that anesthesiologists will need to meet the challenges of this changing pattern of practice.

  16. Assessment of the ethical aspects of boards dentist in jequié-ba

    Directory of Open Access Journals (Sweden)

    Iane Souza Nery Silva

    2013-01-01

    Full Text Available The objective consisted in the evaluation of ethical violations present on the boards of dental clinics in the city of Jequié, according to CFO-Resolution 71 of 2006. Dental advertising boards were photographed, both laid down in front of the doctor's offices and clinics, and the advertising that made these. The photographs were examined by four judges, with use of a computer, whereas as must haves for the presence of the name and the registration number in the CRO and representative name of the profession of dental surgeon; optional items were the presence of areas of practice, if there is this inscription in CRO, academic qualifications, address, telephone number, fax number, e-mail address, work schedule, covenants, accreditations and the term general practitioner; and the items are price, listing offenders free services, payment arrangements, grooming of patients and artifices of advertisement to gain customers. It was found that only ads and plaques were 11,76% the must haves, 88,24% contained optional items and 11,76% were in disagreement with any item of Dental Ethics Code consideredas infringement. It can be concluded that most of the advertisements was not collected in accordance to the current legislation, since in addition to ethical violations have plates 11,76%, 88,24% lacked all items considered mandatory.

  17. Professional ethics in nursing: an integrative review.

    Science.gov (United States)

    Kangasniemi, Mari; Pakkanen, Piiku; Korhonen, Anne

    2015-08-01

    To conduct an integrative review and synthesize current primary studies of professional ethics in nursing. Professional ethics is a familiar concept in nursing and provides an ethical code for nursing practice. However, little is known about how professional ethics has been defined and studied in nursing science. Systematic literature searches from 1948-February 2013, using the CINAHL, PubMed and Scopus electronic databases to look at previously published peer-reviewed studies. A modified version of Cooper's five-stage integrative review was used to review and synthesize current knowledge. Fourteen papers were included in this research. According to our synthesis, professional ethics is described as an intra-professional approach to care ethics and professionals commit to it voluntarily. Professional ethics consist of values, duties, rights and responsibilities, regulated by national legislation and international agreements and detailed in professional codes. Professional ethics is well established in nursing, but is constantly changing due to internal and external factors affecting the profession. Despite the obvious importance of professional ethics, it has not been studied much in nursing science. Greater knowledge of professional ethics is needed to understand and support nurses' moral decision-making and to respond to the challenges of current changes in health care and society. © 2015 John Wiley & Sons Ltd.

  18. [Nationwide Survey on Informed Consent and Ethical Review at Hospitals Conducting Post-marketing Studies Sponsored by Pharmaceutical Companies].

    Science.gov (United States)

    Urushihara, Hisashi; Murakami, Yuka; Matsui, Kenji; Tashiro, Shimon

    2018-01-01

     Under the Japanese drug regulatory system, post-marketing studies (PMS) must be in compliance with Good Post-marketing Study Practice (GPSP). The GPSP Ordinance lacks standards for the ethical conduct of PMSs; although only post-marketing clinical trials are subject to Good Clinical Practice. We conducted a web-based questionnaire survey on the ethical conduct of PMSs in collaboration with the Japanese Society of Hospital Pharmacists and pharmacists belonging to the Society. 1819 hospitals around Japan answered the questionnaire, of which 503 hospitals had conducted company-sponsored PMSs in 2015. 40.2% of the hospitals had obtained informed consent from participating patients in at least one PMS conducted in 2015, the majority of which was in written form. The first and second most frequent reasons for seeking informed consent in PMSs were to meet protocol requirements, followed by the requirement to meet institutional standard operational procedures and the request of the ethical review board of the hospital. Ethical review of PMSs was conducted in 251 hospitals. Despite a lack of standards for informed consent and ethical review in PMSs, a considerable number of study sites employed informed consent and ethical review for PMSs. While company policies and protocols are likely to be major determinants of the ethical conduct of PMSs, the governmental regulatory agency should also play a significant role in implementing a standardized ethical code for the conduct of PMSs.

  19. 32 CFR 881.3 - Individual Service Review Board.

    Science.gov (United States)

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Individual Service Review Board. 881.3 Section... Individual Service Review Board. (a) The Commander, Headquarters Air Force Personnel Center (HQ AFPC/CC) establishes the Individual Service Review Board as necessary. (b) The Board consists of military members in...

  20. Victor Frankenstein's Institutional Review Board Proposal, 1790.

    Science.gov (United States)

    Harrison, Gary; Gannon, William L

    2015-10-01

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

  1. Ethical aspects of registry-based research in the Nordic countries

    Directory of Open Access Journals (Sweden)

    Ludvigsson JF

    2015-11-01

    Full Text Available Jonas F Ludvigsson,1,2 Siri E Håberg,3 Gun Peggy Knudsen,3 Pierre Lafolie,4,5 Helga Zoega,6 Catharina Sarkkola,7 Stephanie von Kraemer,7 Elisabete Weiderpass,1,7–10 Mette Nørgaard11 1Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, 2Department of Pediatrics, Örebro University Hospital, Örebro, Sweden; 3Norwegian Institute of Public Health, Oslo, Norway; 4Department of Medicine, Clinical Pharmacology Unit, 5The Stockholm Regional Ethical Review Board, Karolinska Institutet, Stockholm, Sweden; 6Center of Public Health Sciences, Faculty of Medicine, University of Iceland, Reykjavík, Iceland; 7Genetic Epidemiology Group, Folkhälsan Research Center, Helsinki, Finland; 8Department of Community Medicine, Faculty of Health Sciences, University of Tromsø, 9The Arctic University of Norway, Tromsø, 10Department of Research, Cancer Registry of Norway, Oslo, Norway; 11Department of Clinical Epidemiology, Aarhus University Hospital, Aarhus, Denmark Abstract: National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and

  2. 78 FR 22545 - Performance Review Board

    Science.gov (United States)

    2013-04-16

    ... FURTHER INFORMATION CONTACT: Harriette H. Charbonneau, Director of Human Resources, Federal Maritime... prescribed by the Office of Personnel Management, one or more performance review boards. The board shall..., Managing Director 15. Austin L. Schmitt, Director, Strategic Planning and Regulatory Review [FR Doc. 2013...

  3. 5 CFR 317.502 - Qualifications Review Board certification.

    Science.gov (United States)

    2010-01-01

    ... REGULATIONS EMPLOYMENT IN THE SENIOR EXECUTIVE SERVICE Career Appointments § 317.502 Qualifications Review Board certification. (a) A Qualification Review Board (QRB) convened by OPM must certify the executive... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Qualifications Review Board certification...

  4. Reducing barriers to ethics in neuroscience

    Directory of Open Access Journals (Sweden)

    Judy Illes

    2010-10-01

    Full Text Available Ethics is a growing interest for neuroscientists, but rather than signifying a commitment to the protection of human subjects, care of animals, and public understanding to which the professional community is engaged in a fundamental way, interest has been consumed by administrative overhead and the mission creep of institutional ethics reviews. Faculty, trainees, and staff (N=605 whose work involves brain imaging and brain stimulation completed an online survey about ethics in their research. Using factor analysis and linear regression, we found significant effects for invasiveness of imaging technique, professional position, gender, and local presence of bioethics centers. We propose strategies for improving communication between the neuroscience community and ethics review boards, collaborations between neuroscientists and biomedical ethicists, and ethics training in graduate neuroscience programs to revitalize mutual goals and interests.

  5. Building Capacity in Ethical Review

    DEFF Research Database (Denmark)

    Douglas-Jones, Rachel

    2017-01-01

    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...

  6. Institutional review boards: Challenges and opportunities

    Directory of Open Access Journals (Sweden)

    Ravindra B Ghooi

    2014-01-01

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

  7. The ethics of peer review in bioethics

    Science.gov (United States)

    Wendler, David; Miller, Franklin

    2014-01-01

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

  8. 77 FR 65685 - Senior Executive Service Performance Review Board; Membership

    Science.gov (United States)

    2012-10-30

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9747-4] Senior Executive Service Performance Review Board... performance review boards. This board shall review and evaluate the initial appraisal of a senior executive's... performance of the senior executive. Members of the 2012 EPA Performance Review Board are: Benita Best-Wong...

  9. Organizational ethics: a literature review.

    Science.gov (United States)

    Suhonen, Riitta; Stolt, Minna; Virtanen, Heli; Leino-Kilpi, Helena

    2011-05-01

    The aim of the study was to report the results of a systematically conducted literature review of empirical studies about healthcare organizations' ethics and management or leadership issues. Electronic databases MEDLINE and CINAHL yielded 909 citations. After a two stage application of the inclusion and exclusion criteria 56 full-text articles were included in the review. No large research programs were identified. Most of the studies were in acute hospital settings from the 1990s onwards. The studies focused on ethical challenges, dilemmas in practice, employee moral distress and ethical climates or environments. Study samples typically consisted of healthcare practitioners, operational, executive and strategic managers. Data collection was mainly by questionnaires or interviews and most of the studies were descriptive, correlational and cross-sectional. There is need to develop conceptual clarity and a theoretical framework around the subject of organizational ethics and the breadth of the contexts and scope of the research needs to be increased. © The Author(s) 2011

  10. 77 FR 54570 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2012-09-05

    ... DEFENSE NUCLEAR FACILITIES SAFETY BOARD Senior Executive Service Performance Review Board AGENCY... the Defense Nuclear Facilities Safety Board (DNFSB) Senior Executive Service (SES) Performance Review.... The PRB shall review and evaluate the initial summary rating of the senior executive's performance...

  11. Feasibility of rapid ethical assessment for the Ethiopian health research ethics review system.

    Science.gov (United States)

    Addissie, Adamu; Davey, Gail; Newport, Melanie; Farsides, Bobbie; Feleke, Yeweyenhareg

    2015-01-01

    One of the challenges in the process of ethical medical research in developing countries, including Ethiopia, is translating universal principles of medical ethics into appropriate informed consent documents and their implementation. Rapid Ethical Assessment (REA) has been suggested as a feasible approach to meet this application gap. In the past few years REA has been employed in few research project in Ethiopia and have been found to be a useful and practical approach. Feasibility assessment of REA for the Ethiopian research setting was conducted between 2012-2013 in order to inform the subsequent introduction of REA into research ethics review and governance system in the country. REA was found to be an appropriate, relevant and feasible venture. We argue that REA can be integrated as part of the ethics review and governance system in Ethiopia. REA tools and techniques are considered relevant and acceptable to the Ethiopian research community, with few practical challenges anticipated in their implementation. REA are considered feasible for integration in the Ethiopian ethics review system.

  12. 75 FR 69063 - Senior Executive Service; Performance Review Board

    Science.gov (United States)

    2010-11-10

    ... DEPARTMENT OF ENERGY Senior Executive Service; Performance Review Board AGENCY: U.S. Department of Energy. ACTION: Designation of Performance Review Board Chair. SUMMARY: This notice provides the Performance Review Board Chair designee for the Department of Energy. DATES: This appointment is effective as...

  13. 78 FR 70029 - Senior Executive Service; Performance Review Board

    Science.gov (United States)

    2013-11-22

    ... DEPARTMENT OF ENERGY Senior Executive Service; Performance Review Board AGENCY: U.S. Department of Energy ACTION: Designation of Performance Review Board Co-Chairs. SUMMARY: This notice provides the Performance Review Board Co-Chairs designees for the Department of Energy. DATES: This appointment is...

  14. 77 FR 64969 - Senior Executive Service; Performance Review Board

    Science.gov (United States)

    2012-10-24

    ... DEPARTMENT OF ENERGY Senior Executive Service; Performance Review Board AGENCY: U.S. Department of Energy. ACTION: Designation of Performance Review Board Chair. SUMMARY: This notice provides the Performance Review Board Chair designee for the Department of Energy. DATES: This appointment is effective as...

  15. 77 FR 66191 - Senior Executive Service-Performance Review Board

    Science.gov (United States)

    2012-11-02

    ... OFFICE OF PERSONNEL MANAGEMENT Senior Executive Service--Performance Review Board AGENCY: Office... performance review boards. The board reviews and evaluates the initial appraisal of a senior executive's... performance of the senior executive. U.S. Office of Personnel Management. John Berry, Director. The following...

  16. 76 FR 70713 - Senior Executive Service; Performance Review Board

    Science.gov (United States)

    2011-11-15

    ... DEPARTMENT OF ENERGY Senior Executive Service; Performance Review Board AGENCY: U.S. Department of Energy. ACTION: Designation of Performance Review Board Chair. SUMMARY: This notice provides the Performance Review Board Chair designee for the Department of Energy. DATES: This appointment is effective as...

  17. 76 FR 57712 - Performance Review Board Membership

    Science.gov (United States)

    2011-09-16

    ... DEPARTMENT OF COMMERCE Performance Review Board Membership AGENCY: Economics and Statistics... the Performance Review Board (PRB) in accordance with the Economics and Statistics Administration's.... Bostic, Jr., Arnold A. Jackson, Theodore A. Johnson, Steven J. Jost, J. Steven Landefeld, Jennifer Madans...

  18. 75 FR 57440 - Performance Review Board Membership

    Science.gov (United States)

    2010-09-21

    ... DEPARTMENT OF COMMERCE Performance Review Board Membership AGENCY: Economics and Statistics... the Performance Review Board in accordance with the Economics and Statistics Administration's Senior... Callahan, Nancy M. Gordon, Howard R. Hogan, Arnold A. Jackson, Theodore A. Johnson, Steven J. Jost, J...

  19. 20 CFR 405.410 - Selecting claims for Decision Review Board review.

    Science.gov (United States)

    2010-04-01

    ... will not review claims based on the identity of the administrative law judge who decided the claim. (b... Decision Review Board review. (a)(1) The Board may review your claim if the administrative law judge made a decision under §§ 405.340 or 405.370 of this part, regardless of whether the administrative law judge's...

  20. 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

  1. The ethics of peer review in bioethics.

    Science.gov (United States)

    Wendler, David; Miller, Franklin

    2014-10-01

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

  2. 77 FR 61379 - Performance Review Board Membership

    Science.gov (United States)

    2012-10-09

    ... DEPARTMENT OF COMMERCE Performance Review Board Membership AGENCY: Economics and Statistics... eligible to serve on the Performance Review Board (PRB) in accordance with the Economics and Statistics.... Arnold William G. Bostic, Jr. Joanne Buenzli Crane Justin R. Ehrenwerth Ron S. Jarmin Theodore A. Johnson...

  3. 78 FR 67333 - Performance Review Board Membership

    Science.gov (United States)

    2013-11-12

    ... DEPARTMENT OF COMMERCE Performance Review Board Membership AGENCY: Economics and Statistics... eligible to serve on the Performance Review Board (PRB) in accordance with the Economics and Statistics.... Arnold William G. Bostic, Jr. Stephen B. Burke Joanne Buenzli Crane Susan R. Helper Ron S. Jarmin Enrique...

  4. Nurses' ethical conflicts in performance of utilization reviews.

    Science.gov (United States)

    Bell, Sue Ellen

    2003-09-01

    This article describes the ethical conflicts that a sample of US nurse utilization reviewers faced in their work, and also each nurse's self-reported ethical orientation that was used to resolve the dilemmas. Data were collected from a sample of 97 registered nurses who were working at least 20 hours per week as utilization reviewers. Respondents were recruited from three managed care organizations that conduct utilization reviews in a large midwestern city. A cross-sectional survey design was used to collect demographic data and to ask closed-response, short-answer and open-ended questions. Ethical conflicts reported by nurses were similar across utilization review settings and many were justice orientated. Self-reported ethical orientations were similar across organizations, with beneficence dominating. Implications of these findings are discussed.

  5. Getting the justification for research ethics review right.

    Science.gov (United States)

    Dunn, Michael

    2013-08-01

    Dyck and Allen claim that the current model for mandatory ethical review of research involving human participants is unethical once the harms that accrue from the review process are identified. However, the assumptions upon which the authors assert that this model of research ethics governance is justified are false. In this commentary, I aim to correct these assumptions, and provide the right justificatory account of the requirement for research ethics review. This account clarifies why the subsequent arguments that Dyck and Allen make in the paper lack force, and why the 'governance problem' in research ethics that they allude to ought to be explained differently.

  6. Ethical Guideline to Authors,Editors,and Reviewers

    Institute of Scientific and Technical Information of China (English)

    Editorial office of CHM

    2016-01-01

    Drug products are specific goods with safety and effectiveness in medical health case.All of researchers(authors),reviewers,and editors must abide by medical ethical obligation,and also must deter to the ethical obligation for publication.These guidelines are offered as ethical

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

    Science.gov (United States)

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

    2015-01-01

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

  8. Research ethics for clinical researchers.

    Science.gov (United States)

    Harnett, John D; Neuman, Richard

    2015-01-01

    This chapter describes the history of the development of modern research ethics. The governance of research ethics is discussed and varies according to geographical location. However, the guidelines used for research ethics review are very similar across a wide variety of jurisdictions. The paramount importance of protecting the privacy and confidentiality of research participants is discussed at length. Particular emphasis is placed on the process of informed consent, and step-by-step practical guidelines are described. The issue of research in vulnerable populations is touched upon and guidelines are provided. Practical advice is provided for researchers to guide their interactions with research ethics boards. Issues related to scientific misconduct and research fraud are not dealt with in this paper.

  9. 77 FR 62211 - Senior Executive Services (SES) Performance Review Board: Update

    Science.gov (United States)

    2012-10-12

    ... AGENCY FOR INTERNATIONAL DEVELOPMENT Senior Executive Services (SES) Performance Review Board... International Development, Office of Inspector General's Senior Executive Service Performance Review Board... Performance Review Boards. The board shall review and evaluate the initial appraisal of each USAID OIG senior...

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

    Science.gov (United States)

    Sontag, Michael

    2012-01-01

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

  11. A review of ethical issues in dementia.

    Science.gov (United States)

    Johnson, Rebecca A; Karlawish, Jason

    2015-10-01

    Dementia raises many ethical issues. The present review, taking note of the fact that the stages of dementia raise distinct ethical issues, focuses on three issues associated with stages of dementia's progression: (1) how the emergence of preclinical and asymptomatic but at-risk categories for dementia creates complex questions about preventive measures, risk disclosure, and protection from stigma and discrimination; (2) how despite efforts at dementia prevention, important research continues to investigate ways to alleviate clinical dementia's symptoms, and requires additional human subjects protections to ethically enroll persons with dementia; and (3) how in spite of research and prevention efforts, persons continue to need to live with dementia. This review highlights two major themes. First is how expanding the boundaries of dementias such as Alzheimer's to include asymptomatic but at-risk persons generate new ethical questions. One promising way to address these questions is to take an integrated approach to dementia ethics, which can include incorporating ethics-related data collection into the design of a dementia research study itself. Second is the interdisciplinary nature of ethical questions related to dementia, from health policy questions about insurance coverage for long-term care to political questions about voting, driving, and other civic rights and privileges to economic questions about balancing an employer's right to a safe and productive workforce with an employee's rights to avoid discrimination on the basis of their dementia risk. The review highlights these themes and emerging ethical issues in dementia.

  12. 78 FR 77125 - Senior Executive Service Performance Review Board; Membership

    Science.gov (United States)

    2013-12-20

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9904-20-OARM] Senior Executive Service Performance Review... review boards. This board shall review and evaluate the initial appraisal of a senior executive's... performance of the senior executive. Members of the 2013 EPA Performance Review Board are: Benita Best-Wong...

  13. 76 FR 24802 - Eliminating the Decision Review Board

    Science.gov (United States)

    2011-05-03

    ... 0960-AG80 Eliminating the Decision Review Board AGENCY: Social Security Administration. ACTION: Final rules. SUMMARY: We are eliminating the Decision Review Board (DRB) portions of part 405 of our rules...-level process. DSI also eliminated review by the Appeals Council, the final step in our administrative...

  14. 75 FR 62501 - Senior Executive Service Performance Review Board: Update

    Science.gov (United States)

    2010-10-12

    ... AGENCY FOR INTERNATIONAL DEVELOPMENT Senior Executive Service Performance Review Board: Update... Development, Office of Inspector General's Senior Executive Service Performance Review Board. DATES: September... reference-- USAID OIG Senior Executive Service (SES) Performance Review Board). SUPPLEMENTARY INFORMATION: 5...

  15. 76 FR 78257 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2011-12-16

    ... FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Senior Executive Service Performance Review Board... appointment of the members of the Senior Executive Service Performance Review Boards for the Federal... appropriate personnel actions for members of the Senior Executive Service. DATES: This notice is effective...

  16. Ethics and the ethnography of medical research in Africa

    Science.gov (United States)

    Molyneux, Sassy; Geissler, P. Wenzel

    2008-01-01

    The ethics of medical research have grown as an area of expertise and debate in recent years, with two broad approaches emerging in relation to transnational research: (1) the refinement of guidelines and strengthening of review, processes primarily to protect the right of individual research participants and strengthen interpersonal relations at the micro-level; and (2) considering more centrally, as crucial ethical concerns, the wider interests of whole populations, the functioning of research institutions, the processes of collaboration, and the ethics of inequitable international relations. We see the two areas of debate and action as complementary, and believe that social science conducted in and around transnational medical research environments can bring these two perspectives together in a more ‘situated ethics’ of research. To explore this idea for medical research in Africa, we organized a conference in December 2005 in Kilifi, Kenya. In this introduction we outline the two emerging approaches to medical ethics, summarise each of seven papers selected from the conference for inclusion in this special issue on ethics and ethnography, and finally highlight two areas of lively debate at the conference itself: the appropriateness and value of ethics guidelines and review boards for medical research; and the ethical review of social science research. Together, the papers and debates point to the importance of focusing on the ethics of relationships and on justice in both biomedicine and social science research, and on giving greater voice and visibility to the field staff who often play a crucial and under-supported role in ‘doing ethics’ in the field. They also point to the potential value of social science research on the range of relationships operating at different levels and time scales in medical research, including those surrounding community engagement activities, and the role and functioning of ethics review boards. We conclude by highlighting

  17. 76 FR 1641 - Meeting of the Office of Justice Programs' Science Advisory Board

    Science.gov (United States)

    2011-01-11

    ... and By-Laws, a review of ethics rules applicable to the Board's activities, and briefings from OJP... DEPARTMENT OF JUSTICE Office of Justice Programs [OJP (OJP) Docket No. 1543] Meeting of the Office of Justice Programs' Science Advisory Board AGENCY: Office of Justice Programs (OJP), Justice. ACTION...

  18. 76 FR 76122 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2011-12-06

    ... CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Senior Executive Service Performance Review Board... change in the membership of the Senior Executive Service Performance Review Board for the Chemical Safety... Senior Executive Service (SES) and makes recommendations as to final annual performance ratings for...

  19. 78 FR 67147 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2013-11-08

    ... FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Senior Executive Service Performance Review Board... appointment of the members of the Senior Executive Service Performance Review Boards for the Federal... actions for members of the Senior Executive Service. DATES: This notice is effective November 5, 2013. FOR...

  20. 78 FR 57837 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2013-09-20

    ... CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Senior Executive Service Performance Review Board... change in the membership of the Senior Executive Service Performance Review Board for the Chemical Safety... Senior Executive Service (SES) and makes recommendations as to final annual performance ratings for...

  1. 77 FR 70779 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2012-11-27

    ... FEDERAL RETIREMENT THRIFT INVESTMENT BOARD Senior Executive Service Performance Review Board... appointment of the members of the Senior Executive Service Performance Review Boards for the Federal... actions for members of the Senior Executive Service. DATES: This notice is effective November 27, 2012...

  2. 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.

  3. Nursing ethical values and definitions: A literature review.

    Science.gov (United States)

    Shahriari, Mohsen; Mohammadi, Eesa; Abbaszadeh, Abbas; Bahrami, Masoud

    2013-01-01

    Ethical values offer a framework for behavior assessment, and nursing values influence nurses' goals, strategies, and actions. A literature review was adopted in order to determine and define ethical values for nurses. This literature review was conducted based on the Centre for Reviews and Dissemination guidelines. The key words used to search relevant sources were nursing, ethics, ethical values, and nursing values. The search of articles in English was carried out in Medline, CINAHL, PubMed, Scopus, Ovid, and Proquest databases. The search of articles in Persian was conducted in databases of Magiran, SID, and Irandoc publications. After assessing and analyzing the obtained data, 17 articles which had a distinct definition of ethical values were chosen and subjected to a thorough study. The search yielded 10 nursing ethical values: Human dignity, privacy, justice, autonomy in decision making, precision and accuracy in caring, commitment, human relationship, sympathy, honesty, and individual and professional competency. This study showed that common ethical values are generally shared within the global community. However, in several areas, influences of social, cultural, and economical status and religious beliefs on values result in a different definition of these values. This study revealed that based on humanistic nature of nursing, common values in nursing protect human dignity and respect to the patients. Recognizing and definition of ethical values can help to improve nursing practice and develop codes of ethics.

  4. 75 FR 1028 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2010-01-08

    ... CHEMICAL SAFETY AND HAZARD INVESTIGATION BOARD Senior Executive Service Performance Review Board... change in the membership of the Senior Executive Service Performance Review Board for the Chemical Safety... performance ratings of members of the Senior Executive Service (SES) and makes recommendations as to final...

  5. Ethics of reviewing scientific publications.

    Science.gov (United States)

    Napolitani, Federica; Petrini, Carlo; Garattini, Silvio

    2017-05-01

    The approval or rejection of scientific publications can have important consequences for scientific knowledge, so considerable responsibility lies on those who have to assess or review them. Today it seems that the peer review process, far from being considered an outdated system to be abandoned, is experiencing a new upturn. This article proposes criteria for the conduct of reviewers and of those who select them. While commenting on new emerging models, it provides practical recommendations for improving the peer-review system, like strengthening the role of guidelines and training and supporting reviewers. The process of peer review is changing, it is getting more open and collaborative, but those same ethical principles which guided it from its very origin should remain untouched and be firmly consolidated. The paper highlights how the ethics of reviewing scientific publications is needed now more than ever, in particular with regard to competence, conflict of interest, willingness to discuss decisions, complete transparency and integrity. Copyright © 2016 European Federation of Internal Medicine. Published by Elsevier B.V. All rights reserved.

  6. Ethical Issues Surrounding Personalized Medicine: A Literature Review.

    Science.gov (United States)

    Salari, Pooneh; Larijani, Bagher

    2017-03-01

    More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

  7. The Evolution of American Hospital Ethics Committees: A Systematic Review.

    Science.gov (United States)

    Courtwright, Andrew; Jurchak, Martha

    2016-01-01

    During the 1970s and 1980s, legal precedent, governmental recommendations, and professional society guidelines drove the formation of hospital ethics committees (HECs). The Joint Commission on Accreditation of Health Care Organization's requirements in the early 1990s solidified the role of HECs as the primary mechanism to address ethical issues in patient care. Because external factors drove the rapid growth of HECs on an institution-by-institution basis, however, no initial consensus formed around the structure and function of these committees. There are now almost 40 years of empirical studies on the composition, administration, and activities of HECs in the United States. We conducted a systematic review of the available empirical literature on HECs to describe their evolution. As HECs changed over time, they increased their total number of members and percentage of members from nursing and the community. Although physicians increasingly chaired these committees, their presence as a percentage of overall members declined. The percentage of administrative members remained steady, although committees became increasingly likely to have at least one administrative member. HECs were also increasingly likely to report to an administrative body or to the board of trustees or directors rather than to the medical staff. Finally, consultation volume increased steadily over time. There has not, however, been a national survey of the composition of ethics committees, their administration, or volume of consultation in more than 10 years, despite increasing calls for professional standards and quality improvement assessments among HECs. Copyright 2016 The Journal of Clinical Ethics. All rights reserved.

  8. Ethical Issues Surrounding Personalized Medicine: A Literature Review

    Directory of Open Access Journals (Sweden)

    Pooneh Salari

    2017-03-01

    Full Text Available More than a decade ago, personalized medicine was presented in modern medicine. Personalized medicine means that the right drug should be prescribed for the right patient based on genetic data. No doubt is developing medical sciences, and its shift into personalized medicine complicates ethical challenges more than before. In this review, we categorized all probable ethical considerations of personalized medicine in research and development and service provision. Based on our review, extensive changes in healthcare system including ethical changes are needed to overcome the ethical obstacles including knowledge gap and informed consent, privacy and confidentiality and availability of healthcare services. Furthermore social benefit versus science development and individual benefit should be balanced. Therefore guidelines and regulations should be compiled to represent the ethical framework; also ethical decision making should be day-to-day and individualized.

  9. 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.

  10. 75 FR 6729 - Senior Executive Service (SES) Performance Review Board; Members

    Science.gov (United States)

    2010-02-10

    ... NATIONAL ARCHIVES AND RECORDS ADMINISTRATION Senior Executive Service (SES) Performance Review... Performance Review Boards. The Board shall review the initial appraisal of a senior executive's performance by... senior executive performance. The members of the Performance Review Board for the National Archives and...

  11. Ethics rounds: An appreciated form of ethics support.

    Science.gov (United States)

    Silén, Marit; Ramklint, Mia; Hansson, Mats G; Haglund, Kristina

    2016-03-01

    Ethics rounds are one way to support healthcare personnel in handling ethically difficult situations. A previous study in the present project showed that ethics rounds did not result in significant changes in perceptions of how ethical issues were handled, that is, in the ethical climate. However, there was anecdotal evidence that the ethics rounds were viewed as a positive experience and that they stimulated ethical reflection. The aim of this study was to gain a deeper understanding of how the ethics rounds were experienced and why the intervention in the form of ethics rounds did not succeed in improving the ethical climate for the staff. An exploratory and descriptive design with a qualitative approach was adopted, using individual interviews. A total of 11 healthcare personnel, working in two different psychiatry outpatient clinics and with experience of participating in ethics rounds, were interviewed. The study was based on informed consent and was approved by one of the Swedish Regional Ethical Review Boards. The participants were generally positive about the ethics rounds. They had experienced changes by participating in the ethics rounds in the form of being able to see things from different perspectives as well as by gaining insight into ethical issues. However, these changes had not affected daily work. A crucial question is whether or not increased reflection ability among the participants is a good enough outcome of ethics rounds and whether this result could have been measured in patient-related outcomes. Ethics rounds might foster cooperation among the staff and this, in turn, could influence patient care. By listening to others during ethics rounds, a person can learn to see things from a new angle. Participation in ethics rounds can also lead to better insight concerning ethical issues. © The Author(s) 2014.

  12. 5 CFR 430.310 - Performance Review Boards (PRBs).

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 1 2010-01-01 2010-01-01 false Performance Review Boards (PRBs). 430.310... PERFORMANCE MANAGEMENT Managing Senior Executive Performance § 430.310 Performance Review Boards (PRBs). Each... appraisal. (3) When appraising a career appointee's performance or recommending a career appointee for a...

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

    Science.gov (United States)

    Lawrence, Dana J

    2011-11-01

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

  14. Ethical issues experienced by healthcare workers in nursing homes: Literature review.

    Science.gov (United States)

    Preshaw, Deborah Hl; Brazil, Kevin; McLaughlin, Dorry; Frolic, Andrea

    2016-08-01

    Ethical issues are increasingly being reported by care-providers; however, little is known about the nature of these issues within the nursing home. Ethical issues are unavoidable in healthcare and can result in opportunities for improving work and care conditions; however, they are also associated with detrimental outcomes including staff burnout and moral distress. The purpose of this review was to identify prior research which focuses on ethical issues in the nursing home and to explore staffs' experiences of ethical issues. Using a systematic approach based on Aveyard (2014), a literature review was conducted which focused on ethical and moral issues, nurses and nursing assistants, and the nursing home. The most salient themes identified in the review included clashing ethical principles, issues related to communication, lack of resources and quality of care provision. The review also identified solutions for overcoming the ethical issues that were identified and revealed the definitional challenges that permeate this area of work. The review highlighted a need for improved ethics education for care-providers. © The Author(s) 2015.

  15. Ethical issues in trauma-related research: a review.

    Science.gov (United States)

    Newman, Elana; Risch, Elizabeth; Kassam-Adams, Nancy

    2006-09-01

    ETHICAL DECISION-MAKING ABOUT TRAUMA-RELATED STUDIES requires a flexible approach that counters assumptions and biases about victims, assures a favorable ethical cost-benefit ratio, and promotes advancement of knowledge that can benefit survivors of traumatic stress. This paper reviews several ethical issues in the field of traumatic stress: benefit and risks in trauma-related research, whether trauma-related research poses unique risks and if so what those might be, informed consent and mandatory reporting, and supervision of trauma-related research. For each topic, we review potential ethical issues, summarize the research conducted thus far to inform ethical practice, and recommend future practice, research questions and policies to advance the field so that research on trauma can continue to be a win-win situation for all stakeholders in the research enterprise.

  16. When reviews attack: ethics, free speech, and the peer review process.

    Science.gov (United States)

    Hadjistavropoulos, T; Bieling, P J

    2000-08-01

    The peer review process, whether formally applied in publication and grant review, or informally, such as exchange of ideas in scientific and professional newsgroups, has sparked controversy. Writers in this area agree that scholarly reviews that are inappropriate in tone are not uncommon. Indeed, commentators have suggested rules and guidelines that can be used to improve the review process and to make reviewers more accountable. In this paper, we examine the relevance and impact of ethical codes on the conduct of peer review. It is our contention that the peer review process can be improved, not by a new set of rules but through closer attention to the ethical principles to which we, as psychologists, already subscribe.

  17. Ethical issues in research with homeless youths.

    Science.gov (United States)

    Ensign, Josephine; Ammerman, Seth

    2008-05-01

    This paper is a report of a study to document researcher, healthcare provider and programme administrators' experiences with ethical issues in research with homeless youths in North America. While there are legal and ethical guidelines for research with adolescents and with vulnerable populations in general, there are no specific guidelines for the ethical conduct of research with homeless youths. Using a web-based questionnaire, healthcare and social service providers, programme administrators and researchers working with homeless young people throughout the United States of America and Canada were surveyed in 2005. The survey group consisted of 120 individuals; a total of 72 individuals completed the survey. Survey questions included experiences with using incentives in research with homeless youths, consent and experiences with ethics review boards. Numerical data were analysed using frequencies and cross-tabulations. Text data were analysed qualitatively. Researchers doing mental health and/or substance use research tended to use money as a research incentive, whereas healthcare providers and programme administrators tended to use non-monetary incentives. The majority of respondents reported using written consent for research from homeless youths, including minors. Respondents reporting difficulties with ethics review boards were mainly involved with intervention research. Consensus is needed from a variety of stakeholders, including homeless youths and service providers, on use of various types of research incentives for different types of research, as well as use of consent for homeless youths who are minors.

  18. 40 CFR 26.1603 - Operation of the Human Studies Review Board.

    Science.gov (United States)

    2010-07-01

    ... appropriate for the scientific and ethical review of human research, including research ethics, biostatistics... scientific and ethical aspects of research proposals and reports of completed research with human subjects... 40 Protection of Environment 1 2010-07-01 2010-07-01 false Operation of the Human Studies Review...

  19. National Society of Genetic Counselors Code of Ethics: Explication of 2017 Revisions.

    Science.gov (United States)

    Senter, Leigha; Bennett, Robin L; Madeo, Anne C; Noblin, Sarah; Ormond, Kelly E; Schneider, Kami Wolfe; Swan, Kelli; Virani, Alice

    2018-02-01

    The Code of Ethics (COE) of the National Society of Genetic Counselors (NSGC) was adopted in 1992 and was later revised and adopted in 2006. In 2016, the NSGC Code of Ethics Review Task Force (COERTF) was convened to review the COE. The COERTF reviewed ethical codes written by other professional organizations and suggested changes that would better reflect the current and evolving nature of the genetic counseling profession. The COERTF received input from the society's legal counsel, Board of Directors, and members-at-large. A revised COE was proposed to the membership and approved and adopted in April 2017. The revisions and rationale for each are presented.

  20. 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...

  1. 78 FR 66785 - SES Performance Review Board

    Science.gov (United States)

    2013-11-06

    ... Safety Board. Steven E. Goldberg, Chief Financial Officer, National Transportation Safety Board. John.... Goldberg's rating review). Anthony P. Scardino, Chief Financial Officer, U.S. Patent and Trademark Office... CONTACT: Emily T. Carroll, Chief, Human Resources Division, Office of Administration, National...

  2. Internet research and ethics: transformative issues in nursing education research.

    Science.gov (United States)

    Mahon, Pamela Young

    2014-01-01

    As practice in the educational and clinical settings seeks to be evidence based, faculty are increasingly required to conduct research and publish the results to advance the science of our profession. The purpose of this article is to discuss transformative research ethics because Internet use is an increasing component of current research studies. How nurse educators can engage in research-utilizing methodologies inclusive of technology while adhering to ethical standards developed before the advance of the Internet is reviewed. Recommendations are cited to address the new questions that arise at institutional review board meetings resulting from potential ethical implications of using students or research participants in cyber space. © 2014.

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

    Science.gov (United States)

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

    2015-07-01

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

  4. Evaluation of ethics education in obstetrics and gynecology residency programs.

    Science.gov (United States)

    Byrne, John; Straub, Heather; DiGiovanni, Laura; Chor, Julie

    2015-03-01

    The objective of the study was to assess the current status of ethics education in obstetrics-gynecology residency programs. A cross-sectional, web-based survey was designed in conjunction with a professional survey laboratory at the University of Chicago. The survey was piloted with a convenience sample of clinical medical ethics fellows to assess question content and clarity. The survey was deployed by e-mail to all obstetrics-gynecology residency program directors. Descriptive statistics were used to analyze participant responses. The University of Chicago's Institutional Review Board deemed this study exempt from institutional review board formal review. Of 242 eligible obstetrics-gynecology residency program directors, 118 (49%) completed the survey. Most respondents were from university-based programs (n = 78, 66%) that were not religiously affiliated (n = 98, 83%) and trained 4-6 residents per postgraduate year (n = 64, 70%). Although 50% of program directors (n = 60) reported having ethics as part of their core curriculum, most programs teach ethics in an unstructured manner. Fifty-seven percent of respondents (n = 66) stated their program dedicated 5 or fewer hours per year to ethics. The majority of program directors (n = 80, 73%) responded they would like more to a lot more ethics education and believed that ethics education should be required (n = 93, 85%) for residents to complete their training. Respondents identified that crowding in the curriculum was a significant barrier to increased ethics training (n = 50, 45%) and two-thirds (n = 74, 67%) reported a lack of faculty expertise as a moderate barrier to providing ethics education in the residency curriculum. This study found that a lack of structured curricula, inadequate faculty expertise, and limited time were important barriers for ethics education in obstetrics-gynecology programs across the nation. Despite these existing challenges, program directors have a strong interest in increasing ethics

  5. Clinical Ethics Support for Healthcare Personnel: An Integrative Literature Review.

    Science.gov (United States)

    Rasoal, Dara; Skovdahl, Kirsti; Gifford, Mervyn; Kihlgren, Annica

    2017-12-01

    This study describes which clinical ethics approaches are available to support healthcare personnel in clinical practice in terms of their construction, functions and goals. Healthcare personnel frequently face ethically difficult situations in the course of their work and these issues cover a wide range of areas from prenatal care to end-of-life care. Although various forms of clinical ethics support have been developed, to our knowledge there is a lack of review studies describing which ethics support approaches are available, how they are constructed and their goals in supporting healthcare personnel in clinical practice. This study engages in an integrative literature review. We searched for peer-reviewed academic articles written in English between 2000 and 2016 using specific Mesh terms and manual keywords in CINAHL, MEDLINE and Psych INFO databases. In total, 54 articles worldwide described clinical ethics support approaches that include clinical ethics consultation, clinical ethics committees, moral case deliberation, ethics rounds, ethics discussion groups, and ethics reflection groups. Clinical ethics consultation and clinical ethics committees have various roles and functions in different countries. They can provide healthcare personnel with advice and recommendations regarding the best course of action. Moral case deliberation, ethics rounds, ethics discussion groups and ethics reflection groups support the idea that group reflection increases insight into ethical issues. Clinical ethics support in the form of a "bottom-up" perspective might give healthcare personnel opportunities to think and reflect more than a "top-down" perspective. A "bottom-up" approach leaves the healthcare personnel with the moral responsibility for their choice of action in clinical practice, while a "top-down" approach risks removing such moral responsibility.

  6. Ethical tensions: A qualitative systematic review of new graduate perceptions.

    Science.gov (United States)

    Hazelwood, Tori; Murray, Carolyn M; Baker, Amy; Stanley, Mandy

    2017-01-01

    New graduate transition into the workforce is challenging and can involve managing ethical tensions. Ethical tensions cause new graduates to doubt their capabilities due to their lack of experience. To support new graduates, we need to know what these ethical tensions are. To explore the ethical tensions perceived to occur in practice for new graduate health professionals. This qualitative systematic review involved a search of five databases (Medline, EMBASE, AMED, CINAHL and Scopus) which resulted in the retrieval of 3554 papers. After the two-phased screening process, eight studies were identified that met the inclusion criteria and had rich data on the review question. Articles were read several times, critically appraised and analysed through thematic analysis. Ethical considerations: No ethical approval was required for the systematic review. The review was conducted following well-established reporting guidelines enabling transparency and rigour. Studies originated from Australia, United States, Iran and China. One study included speech pathologists and seven were with nurses. Four themes included the following: (1) enduring an unknown workplace culture that generates uncertainty without support for new graduates; (2) being vulnerable because of distress from bullying, exclusion and being a scapegoat; (3) constraining systems and institutional restrictions that cause dilemmas; and (4) experiencing disillusionment from lost ideals about ethical practice. This review has brought to light the vulnerability of new graduates to negative workplace culture and collegial incivility. In addition, new graduates are subjected to ethical tensions created by institutional constraints which can create dilemmas and uncertainties through practice that does not align with what they anticipated. Understanding ethical tensions experienced by new graduates enables provision of informed support. There needs to be considerable cultural change for orientation and socialisation of

  7. Ethics in nursing: A systematic review of the framework of evidence perspective.

    Science.gov (United States)

    Yıldız, Erman

    2017-01-01

    To determine the current state of knowledge on nursing and ethics and to assess the knowledge and experience based on the evidence in this regard. Although ethics is at the center of the nursing profession and the ethical issues affecting nurses are given much importance, few studies have focused on professional ethics in nursing. In this respect, ethics has become a concept that contains controversial and ambiguous situations. The Preferred Reporting Items for Systematic Reviews and Meta-analyses guide, a basic search algorithm, was taken. Cochrane, PubMed, CINAHL Complete, PsycINFO, and ULAKBIM from 2012 to 2016. Following a systematic search strategy, all papers were assessed in relation to inclusion criteria and type of study. When sufficient information was not available in the title and summary of the works, the necessary data were evaluated in full texts. This review was completed with 27 articles meeting the research criteria. The evaluation identified six themes: (1) ethics and nursing, (2) ethical difficulties/ethical dilemmas and nursing, (3) ethical competence and nursing, (4) professional ethics and nursing, (5) ethics, education, and nursing, and (6) ethics in health research. As a result of the review, a synthesis of high evidence-level research relating to nursing ethics was obtained. The emphasis was on the importance of further research and education so that the ethical aspects of nursing can be better understood throughout the studies. Nursing researchers' level of evidence on ethics and their orientation to high research design will shed light on uncertain and controversial aspects of the subject. Ethical consideration: Since this was a systematic review, no ethical approval was required. There is no conflict of interest in this literature review.

  8. Perceptions about safety and risks in gender-based violence research: implications for the ethics review process.

    Science.gov (United States)

    Sikweyiya, Yandisa; Jewkes, Rachel

    2011-10-01

    Does research on gender-based violence (GBV) pose greater than minimal risk to researchers and participants? This question needs to be understood particularly in light of hesitancy by Institutional Review Boards to approve research on GBV. The safety and risks of doing GBV studies and the implications for the ethical review process have not been a focus of much research. This qualitative study collected data through in-depth interviews with 12 experienced GBV researchers from various countries and a desk review. This paper explores researchers' interpretation of and meanings of the safety recommendations as provided in the WHO guidelines and whether there is empirical evidence on the presence of risks and safety concerns unique to GBV research. Informants raised a number of safety concerns about GBV research, yet in the interviews there were very few examples of problems having occurred, possibly because of the precautions applied. This paper argues that the notion that GBV studies carry greater than minimal risk when ethics precautions are followed is based on speculation, not evidence. It highlights the need for empirical evidence to support assertions of risk in research.

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

    Science.gov (United States)

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

    2016-01-01

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

  10. Ethical issues in publishing in predatory journals.

    Science.gov (United States)

    Ferris, Lorraine E; Winker, Margaret A

    2017-06-15

    Predatory journals, or journals that charge an article processing charge (APC) to authors, yet do not have the hallmarks of legitimate scholarly journals such as peer review and editing, Editorial Boards, editorial offices, and other editorial standards, pose a number of new ethical issues in journal publishing. This paper discusses ethical issues around predatory journals and publishing in them. These issues include misrepresentation; lack of editorial and publishing standards and practices; academic deception; research and funding wasted; lack of archived content; and undermining confidence in research literature. It is important that the scholarly community, including authors, institutions, editors, and publishers, support the legitimate scholarly research enterprise, and avoid supporting predatory journals by not publishing in them, serving as their editors or on the Editorial Boards, or permitting faculty to knowingly publish in them without consequences.

  11. Public health ethics theory: review and path to convergence.

    Science.gov (United States)

    Lee, Lisa M

    2012-01-01

    Public health ethics is a nascent field, emerging over the past decade as an applied field merging concepts of clinical and research ethics. Because the "patient" in public health is the population rather than the individual, existing principles might be weighted differently, or there might be different ethical principles to consider. This paper reviewed the evolution of public health ethics, the use of bioethics as its model, and the proposed frameworks for public health ethics through 2010. Review of 13 major public health ethics frameworks published over the past 15 years yields a wide variety of theoretical approaches, some similar foundational values, and a few similar operating principles. Coming to a consensus on the reach, purpose, and ends of public health is necessary if we are to agree on what ethical underpinnings drive us, what foundational values bring us to these underpinnings, and what operating principles practitioners must implement to make ethical decisions. If public health is distinct enough from clinical medicine to warrant its own set of ethical and philosophical underpinnings, then a decision must be made as to whether a single approach is warranted or we can tolerate a variety of equal but different perspectives. © 2012 American Society of Law, Medicine & Ethics, Inc.

  12. 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.

  13. A qualitative description of service providers' experiences of ethical issues in HIV care.

    Science.gov (United States)

    Sabone, Motshedisi B; Mogobe, Keitshokile Dintle; Matshediso, Ellah; Shaibu, Sheila; Ntsayagae, Esther I; Corless, Inge B; Cuca, Yvette P; Holzemer, William L; Dawson-Rose, Carol; Baez, Solymar S Soliz; Rivero-Mendz, Marta; Webel, Allison R; Eller, Lucille Sanzero; Reid, Paula; Johnson, Mallory O; Kemppainen, Jeanne; Reyes, Darcel; Nokes, Kathleen; Wantland, Dean; Nicholas, Patrice K; Lingren, Teri; Portillo, Carmen J; Sefcik, Elizabeth; Long-Middleton, Ellen

    2018-01-01

    Managing HIV treatment is a complex multi-dimensional task because of a combination of factors such as stigma and discrimination of some populations who frequently get infected with HIV. In addition, patient-provider encounters have become increasingly multicultural, making effective communication and provision of ethically sound care a challenge. This article explores ethical issues that health service providers in the United States and Botswana encountered in their interaction with patients in HIV care. A descriptive qualitative design was used to collect data from health service providers and patients using focused group discussions. This article is based on responses from health service providers only. Participants and context: This article is based on 11 focused group discussions with a total sample of 71 service providers in seven US sites and one Botswana site. Ethical considerations: Ethical review boards at all the study sites reviewed the study protocol and approved it. Ethical review boards of the study's coordinating centers, Rutgers University and the University of California at San Francisco, also approved it. The study participants provided a written informed consent to participate. HIV service providers encountered ethical challenges in all the four Beauchamp and Childress' biomedical ethics of respect for patients' autonomy, beneficence, justice, and nonmaleficence. The finding that HIV service providers encounter ethical challenges in their interaction with patients is supported by prior studies. The ethical challenges are particularly prominent in multicultural care and resource-constrained care environments. Provision of HIV care is fraught with ethical challenges that tend to pose different issues depending on a given care environment. It is important that strong partnerships are developed among key stakeholders in HIV care. In addition, health service providers need to be provided with resources so they can provide quality and ethically sound

  14. Ethical challenges in conducting research in humanitarian crisis ...

    African Journals Online (AJOL)

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

  15. Ethics interventions for healthcare professionals and students: A systematic review.

    Science.gov (United States)

    Stolt, Minna; Leino-Kilpi, Helena; Ruokonen, Minka; Repo, Hanna; Suhonen, Riitta

    2018-03-01

    The ethics and value bases in healthcare are widely acknowledged. There is a need to improve and raise awareness of ethics in complex systems and in line with competing needs, different stakeholders and patients' rights. Evidence-based strategies and interventions for the development of procedures and practice have been used to improve care and services. However, it is not known whether and to what extent ethics can be developed using interventions. To examine ethics interventions conducted on healthcare professionals and healthcare students to achieve ethics-related outcomes. A systematic review. Five electronic databases were searched: CINAHL, the Cochrane Library, Philosopher's Index, PubMed and PsycINFO. We searched for published articles written in English without a time limit using the keywords: ethic* OR moral* AND intervention OR program OR pre-post OR quasi-experimental OR rct OR experimental AND nurse OR nursing OR health care. In the four-phased retrieval process, 23 full texts out of 4675 citations were included in the review. Data were analysed using conventional content analysis. Ethical consideration: This systematic review was conducted following good scientific practice in every phase. It is possible to affect the ethics of healthcare practices through professionals and students. All the interventions were educational in type. Many of the interventions were related to the ethical or moral sensitivity of the professionals, such as moral courage and empowerment. A few of the interventions focused on identifying ethical problems or research ethics. Patient-related outcomes followed by organisational outcomes can be improved by ethics interventions targeting professionals. Such outcomes are promising in developing ethical safety for healthcare patients and professionals.

  16. Ethical considerations for peer review in forensic neuropsychology.

    Science.gov (United States)

    Johnson-Greene, Doug; Bechtold, Kathleen T

    2002-02-01

    The role of an expert is to assist the trier of fact in weighing evidence and reaching conclusions. Critical evaluation of opposing experts is an integral part of this process. In more recent times, cross-examination has given way to critical evaluation of opposing experts outside of the courtroom, a tactic we refer to as peer review in this paper. Though neuropsychologists frequently review the work of their colleagues, we are concerned here primarily with commentary that is at best misleading, and occasionally malicious, unethical, and unprofessional. Despite a growing trend to use experts as peer reviewers in the medicolegal arena, expectations concerning ethical and professional conduct of neuropsychologists have been absent. Enforcement of appropriate conduct is further complicated by the ambiguity of existing ethical standards and state statutes, and their limited applicability to all neuropsychologists who provide forensic services. This article provides an overview of ethical and professional issues pertaining to forensic peer review and concludes with recommendations for appropriate professional conduct.

  17. 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

  18. Ethical Business Cultures: A Literature Review and Implications for HRD

    Science.gov (United States)

    Ardichvili, Alexandre; Jondle, Douglas

    2009-01-01

    This literature review identifies characteristics of ethical business cultures, describes factors, considered to be important in developing such cultures, describes current practices of developing ethical culture programs, and discusses the role of HRD in developing ethical business cultures. We argue that ethical thinking and behavior can be…

  19. Ethical Risk Management Education in Engineering: A Systematic Review.

    Science.gov (United States)

    Guntzburger, Yoann; Pauchant, Thierry C; Tanguy, Philippe A

    2017-04-01

    Risk management is certainly one of the most important professional responsibilities of an engineer. As such, this activity needs to be combined with complex ethical reflections, and this requirement should therefore be explicitly integrated in engineering education. In this article, we analyse how this nexus between ethics and risk management is expressed in the engineering education research literature. It was done by reviewing 135 articles published between 1980 and March 1, 2016. These articles have been selected from 21 major journals that specialize in engineering education, engineering ethics and ethics education. Our review suggests that risk management is mostly used as an anecdote or an example when addressing ethics issues in engineering education. Further, it is perceived as an ethical duty or requirement, achieved through rational and technical methods. However, a small number of publications do offer some critical analyses of ethics education in engineering and their implications for ethical risk and safety management. Therefore, we argue in this article that the link between risk management and ethics should be further developed in engineering education in order to promote the progressive change toward more socially and environmentally responsible engineering practices. Several research trends and issues are also identified and discussed in order to support the engineering education community in this project.

  20. A systematic review of ethics knowledge in audiology (1980-2010).

    Science.gov (United States)

    Naudé, Alida Maryna; Bornman, Juan

    2014-06-01

    The purpose of this research was to apply multiple perspectives as part of a systematic review to analyze literature regarding ethics in audiology. Audiologists are particularly vulnerable to the changing requirements of the discipline that compel them to straddle both professional obligations and business principles, creating a hybrid professional. The authors used a 2-phase mixed-method approach to analyze publications. Publications were sorted into categories, namely, ethics approach, author, decade, role of the audiologist, component of morality, and common themes. The sample consisted of peer-reviewed articles cited in MEDLINE, CINAHL, ERIC, MasterFILE Premier, E-Journals, Africa-Wide Information, and Academic Search Premier electronic databases and non-peer-reviewed articles in Seminars in Hearing. The publications were predominantly philosophical, focused on the rehabilitative role of the audiologist, and addressed the moral judgment component of moral behavior. Despite the fact that knowledge of ethics grew between 1980 and 2010, this retrospective analysis identified gaps in current knowledge. Research is needed to address the unique ethical problems commonly encountered in all 8 roles of the audiologist; patient perspectives on ethics; ethical approaches; factors affecting moral judgment, sensitivity, motivation, and courage; and cultural dimensions of ethical practice in audiology.

  1. 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.

  2. Research Ethics II: Mentoring, Collaboration, Peer Review, and Data Management and Ownership

    Science.gov (United States)

    Horner, Jennifer; Minifie, Fred D.

    2011-01-01

    Purpose: In this series of articles--"Research Ethics I", "Research Ethics II", and "Research Ethics III"--the authors provide a comprehensive review of the 9 core domains for the responsible conduct of research (RCR) as articulated by the Office of Research Integrity. In "Research Ethics II", the authors review the RCR domains of mentoring,…

  3. Ethical concerns of nursing reviewers: an international survey.

    Science.gov (United States)

    Broome, Marion; Dougherty, Molly C; Freda, Margaret C; Kearney, Margaret H; Baggs, Judith G

    2010-11-01

    Editors of scientific literature rely heavily on peer reviewers to evaluate the integrity of research conduct and validity of findings in manuscript submissions. The purpose of this study was to describe the ethical concerns of reviewers of nursing journals. This descriptive cross-sectional study was an anonymous online survey. The findings reported here were part of a larger investigation of experiences of reviewers. Fifty-two editors of nursing journals (six outside the USA) agreed to invite their review panels to participate. A 69-item forced-choice and open-ended survey developed by the authors based on the literature was pilot tested with 18 reviewers before being entered into SurveyMonkey(TM). A total of 1675 reviewers responded with useable surveys. Six questions elicited responses about ethical issues, such as conflict of interest, protection of human research participants, plagiarism, duplicate publication, misrepresentation of data and 'other'. The reviewers indicated whether they had experienced such a concern and notified the editor, and how satisfied they were with the outcome. They provided specific examples. Approximately 20% of the reviewers had experienced various ethical dilemmas. Although the majority reported their concerns to the editor, not all did so, and not all were satisfied with the outcomes. The most commonly reported concern perceived was inadequate protection of human participants. The least common was plagiarism, but this was most often reported to the editor and least often led to a satisfactory outcome. Qualitative responses at the end of the survey indicate this lack of satisfaction was most commonly related to feedback provided on resolution by the editor. The findings from this study suggest several areas that editors should note, including follow up with reviewers when they identify ethical concerns about a manuscript.

  4. Ethical aspects of registry-based research in the Nordic countries.

    Science.gov (United States)

    Ludvigsson, Jonas F; Håberg, Siri E; Knudsen, Gun Peggy; Lafolie, Pierre; Zoega, Helga; Sarkkola, Catharina; von Kraemer, Stephanie; Weiderpass, Elisabete; Nørgaard, Mette

    2015-01-01

    National health care registries in the Nordic countries share many attributes, but different legal and ethical frameworks represent a challenge to promoting effective joint research. Internationally, there is a lack of knowledge about how ethical matters are considered in Nordic registry-based research, and a lack of knowledge about how Nordic ethics committees operate and what is needed to obtain an approval. In this paper, we review ethical aspects of registry-based research, the legal framework, the role of ethics review boards in the Nordic countries, and the structure of the ethics application. We discuss the role of informed consent in registry-based research and how to safeguard the integrity of study participants, including vulnerable subjects and children. Our review also provides information on the different government agencies that contribute registry-based data, and a list of the major health registries in Denmark, Finland, Iceland, Norway, and Sweden. Both ethical values and conditions for registry-based research are similar in the Nordic countries. While Denmark, Finland, Iceland, Norway, and Sweden have chosen different legal frameworks, these differences can be resolved through mutual recognition of ethical applications and by harmonizing the different systems, likely leading to increased collaboration and enlarged studies.

  5. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

    Science.gov (United States)

    Nicholls, Stuart G; Hayes, Tavis P; Brehaut, Jamie C; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

    2015-01-01

    To date there is no established consensus of assessment criteria for evaluating research ethics review. We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

  6. 78 FR 63275 - Senior Executive Service Performance Review Boards Membership

    Science.gov (United States)

    2013-10-23

    ... DEPARTMENT OF TRANSPORTATION Office of the Secretary [Docket No. DOT-OST-2013-0184] Senior Executive Service Performance Review Boards Membership AGENCY: Office of the Secretary, Department of Transportation (DOT). ACTION: Notice of Performance Review Board (PRB) appointments. SUMMARY: DOT publishes the...

  7. 77 FR 43900 - Senior Executive Service Performance Review Boards Membership

    Science.gov (United States)

    2012-07-26

    ... DEPARTMENT OF TRANSPORTATION Office of the Secretary [Docket No. DOT-OST-2012-0111] Senior Executive Service Performance Review Boards Membership AGENCY: Office of the Secretary, Department of Transportation (DOT). ACTION: Notice of Performance Review Board (PRB) appointments. SUMMARY: DOT publishes the...

  8. 76 FR 63986 - Senior Executive Service Performance Review Boards Membership

    Science.gov (United States)

    2011-10-14

    ... DEPARTMENT OF TRANSPORTATION Office of the Secretary [Docket No. DOT-OST-2011-0188] Senior Executive Service Performance Review Boards Membership AGENCY: Office of the Secretary, Department of Transportation (DOT). ACTION: Notice of Performance Review Board (PRB) appointments. SUMMARY: DOT publishes the...

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

    Science.gov (United States)

    Rice, Todd W

    2008-10-01

    Biomedical research with human subjects has expanded outside of traditional medical centers and hospitals into other health care entities, such as rehabilitation facilities, free-standing out-patient treatment centers, and even home-health agencies. Regardless of the location, federal regulations mandate that all human-subjects research must be overseen by an institutional review board (IRB) or ethics committee to ensure the research abide by the Code of Federal Regulations. Consequently, all human-subjects research must be reviewed and approved by an IRB prior to initiation of any research procedures. Unfortunately, many of these nontraditional research facilities do not have easy access to an IRB. This does not render such research exempt from federal oversight. Clinicians at these facilities have viable options for obtaining IRB approval and legally conducting such research. This paper outlines the available options and their pros and cons.

  10. Contesting the science/ethics distinction in the review of clinical research

    Science.gov (United States)

    Dawson, Angus J; Yentis, Steve M

    2007-01-01

    Recent policy in relation to clinical research proposals in the UK has distinguished between two types of review: scientific and ethical. This distinction has been formally enshrined in the recent changes to research ethics committee (REC) structure and operating procedures, introduced as the UK response to the EU Directive on clinical trials. Recent reviews and recommendations have confirmed the place of the distinction and the separate review processes. However, serious reservations can be mounted about the science/ethics distinction and the policy of separate review that has been built upon it. We argue here that, first, the science/ethics distinction is incoherent, and, second, that RECs should not only be permitted to consider a study's science, but that they have anobligation do so. PMID:17329389

  11. Ethical Issues in Qualitative E-Learning Research

    Directory of Open Access Journals (Sweden)

    Heather Kanuka

    2007-06-01

    Full Text Available In the mid 1980s education researchers began exploring the use of the Internet within teaching and learning practices, now commonly referred to as e-learning. At the same time, many e-learning researchers were discovering that the application of existing ethical guidelines for qualitative research was resulting in confusion and uncertainty among both researchers and ethics review board members. Two decades later we continue to be plagued by these same ethical issues. On reflection on our research practices and examination of the literature on ethical issues relating to qualitative Internet- and Web-based research, the authors conclude that there are three main areas of confusion and uncertainty among researchers in the field of e-learning: (a participant consent, (b public versus private ownership, and (c confidentiality and anonymity.

  12. 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

  13. The role of national ethics commissions in Finland.

    Science.gov (United States)

    Halila, Ritva

    2003-08-01

    There are six national ethics commissions in Finland. The National Advisory Board on Research Ethics was first established in 1991, followed by the National Advisory Board on Biotechnology and the Board on Gene Technology in 1995. The National Advisory Board on Health Care Ethics was established in 1998, followed by its Sub-Committee on Medical Research Ethics in 1999. The Co-operation Group for Laboratory Animal Sciences was established in 2001. Only the Board on Gene Technology works as a national authority and gives binding opinions and recommendations about the use of genetically modified organisms. The Sub-Committee on Medical Research Ethics acts a national research ethics committee and gives opinions about research projects. Other advisory boards do not make legally binding decisions, but their expertise gives a lot of power to their opinions and statements. The commissions work in close collaboration with each other, having regular meetings. They arrange seminars and conferences, and share information with each other. The commissions also share duties and information in international collaboration. How the voice and opinions of these commissions is heard in society lies in the wide, multi-professional expertise of their members. Large commissions and wide expertise may make it difficult to find consensus in their opinions and statements, although wide expertise may, more than discussion in a small expert group, help to further process difficult ethical issues. Collaboration between different bodies is important in order to share duties, and also to add more emphasis to the statements and opinions where different bodies share interests. In our country, the interest that national commissions share is research ethics, where the advisory boards and their members have discharged collaborative activities for years.

  14. 76 FR 65503 - Performance Review Board Membership

    Science.gov (United States)

    2011-10-21

    ... CONTACT: Andrea Burckman, Director, Executive Resources Division, Human Capital and Client Services... DEPARTMENT OF EDUCATION Performance Review Board Membership AGENCY: Office of Management... of Education is composed of career and non-career senior executives. The PRB reviews and evaluates...

  15. 20 CFR 405.420 - Effect of Decision Review Board action on the right to seek judicial review.

    Science.gov (United States)

    2010-04-01

    ... § 405.420 Effect of Decision Review Board action on the right to seek judicial review. (a)(1) Subject to... must wait for the Board to take action. The appeal rights, if any, that will be available at that time... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Effect of Decision Review Board action on the...

  16. ETHICAL REVIEW OF BIOMEDICAL RESEARCH IN BELARUS: CURRENT STATUS, PROBLEMS AND PERSPECTIVES.

    Science.gov (United States)

    Famenka, Andrei

    2011-04-01

    The paper provides description of the system of ethical review for biomedical research in Belarus, with special emphasis on its historical background, legal and regulatory framework, structure and functioning. It concludes that the situation with research ethics in Belarus corresponds to the tendency of bureaucratic approach to establishment of systems of ethical review for biomedical research, observed in a number of countries of Central and Eastern Europe. Different social, economical and political factors of transition have major impact on capacities of the Belarusian RECs to ensure adequate protection of human subjects. Among the main problems identified are non-equivalent stringency of ethical review for different types of biomedical research; lack of independence, multidisciplinarity, pluralism and lay representation experienced by RECs; low level of research ethics education and transparency of RECs activities. Recommendations are made to raise the issue of research ethics on the national agenda in order to develop and maintain the research ethics system capable to effectively protect research participants and promote ethical conduct in research.

  17. A Selected Review of the Underpinnings of Ethics for Human Performance Technology Professionals--Part One: Key Ethical Theories and Research.

    Science.gov (United States)

    Dean, Peter J.

    1993-01-01

    Provides a review of the key ethical theories and relevant empirical research relating to the practice of human performance technology. Topics addressed include ethics, morals, business ethics, ethics officers, empiricism versus normative ethical theory, consequentialism, utilitarianism, nonconsequentialism, Kohlberg model of cognitive moral…

  18. 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

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

    Science.gov (United States)

    Beyrer, Chris; Kass, Nancy E

    2002-07-20

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

  20. 75 FR 68668 - Senior Executive Service; Departmental Performance Review Board

    Science.gov (United States)

    2010-11-08

    ... DEPARTMENT OF THE TREASURY Senior Executive Service; Departmental Performance Review Board AGENCY: Treasury Department. ACTION: Notice of members of the Departmental Offices Performances Review Board. SUMMARY: Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members of the...

  1. A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making

    Directory of Open Access Journals (Sweden)

    Steven P. McCulloch

    2018-06-01

    Full Text Available Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE,~foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Committee and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an “Ethics Council for Animal Policy” to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs and examine some widely used ethical frameworks (e.g., Banner’s principles and the ethical matrix. The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i Problematisation of the policy issue, (ii utilitarian analysis, (iii animal rights analysis, (iv virtue-based analysis, (v animal welfare ethic analysis, and (vi integrated ethical analysis. The~paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

  2. A Proposal for a UK Ethics Council for Animal Policy: The Case for Putting Ethics Back into Policy Making.

    Science.gov (United States)

    McCulloch, Steven P; Reiss, Michael J

    2018-06-07

    Substantial controversy is a consistent feature of UK animal health and welfare policy. BSE, foot and mouth disease, bovine TB and badger culling, large indoor dairies, and wild animals in circuses are examples. Such policy issues are inherently normative; they include a substantial moral dimension. This paper reviews UK animal welfare advisory bodies such as the Animal Health and Welfare Board of England, the Farm Animal Welfare Council and the Animals in Science Committee. These bodies play a key advisory role, but do not have adequate expertise in ethics to inform the moral dimension of policy. We propose an "Ethics Council for Animal Policy" to inform the UK government on policy that significantly impacts sentient species. We review existing Councils (e.g., the Nuffield Council on Bioethics and The Netherlands Council on Animal Affairs) and examine some widely used ethical frameworks (e.g., Banner's principles and the ethical matrix). The Ethics Council for Animal Policy should be independent from government and members should have substantial expertise in ethics and related disciplines. A pluralistic six-stage ethical framework is proposed: (i) Problematisation of the policy issue, (ii) utilitarian analysis, (iii) animal rights analysis, (iv) virtue-based analysis, (v) animal welfare ethic analysis, and (vi) integrated ethical analysis. The paper concludes that an Ethics Council for Animal Policy is necessary for just and democratic policy making in all societies that use sentient nonhuman species.

  3. Improving the Level and Quality of Ethics Review in Chinese Medicine and Integrative Medicine.

    Science.gov (United States)

    Zhang, Cheng-Bin; Li, En-Chang

    2018-04-01

    Three features of ethics review in Chinese medicine (CM) and integrative medicine (IM) were put forward in this paper. It is consistent with the principles of ethical review in Western medicine; it has to be compliant with the laws of CM and IM; emphasis should be laid on the review of clinical practice facts and experience. Three problems were pointed out. The characteristics of CM and IM are not distinctive enough, operation procedures need to be refined and effectiveness remains to be improved. Based on the mentioned above, seven measures were proposed to improve the level and quality of ethics review in CM and IM, including better brand awareness, considerable tolerance, treatment based on disease differentiation and syndrome differentiation, scientific review and toxicity and side effects of CM, perfection of the ethics review system, reasonable procedures of ethics review and more specialized ethics review workers.

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

    Science.gov (United States)

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

    2014-09-01

    Clinical ethics support mechanisms in healthcare are increasing but little is known about the specific developments in elderly care. The aim of this paper is to present a systematic literature review on the characteristics of existing ethics support mechanisms in institutional elderly care. A review was performed in three electronic databases (Pubmed, CINAHL/PsycINFO, Ethxweb). Sixty papers were included in the review. The ethics support mechanisms are classified in four categories: 'institutional bodies' (ethics committee and consultation team); 'frameworks' (analytical tools to assist care professionals); 'educational programmes and moral case deliberation'; and 'written documents and policies'. For each category the goals, methods and ways of organising are described. Ethics support often serves several goals and can be targeted at various levels: case, professional or organisation. Over the past decades a number of changes have taken place in the development of ethics support in elderly care. Considering the goals, ethics support has become more outreaching and proactive, aiming to qualify professionals to integrate ethics in daily care processes. The approaches in clinical ethics support have become more diverse, more focused on everyday ethical issues and better adapted to the concrete learning style of the nursing staff. Ethics support has become less centrally organised and more connected to local contexts and primary process within the organisation. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  5. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review.

    Directory of Open Access Journals (Sweden)

    Stuart G Nicholls

    Full Text Available To date there is no established consensus of assessment criteria for evaluating research ethics review.We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction.Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial--randomised or otherwise--of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review.Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review.

  6. A Scoping Review of Empirical Research Relating to Quality and Effectiveness of Research Ethics Review

    Science.gov (United States)

    Nicholls, Stuart G.; Hayes, Tavis P.; Brehaut, Jamie C.; McDonald, Michael; Weijer, Charles; Saginur, Raphael; Fergusson, Dean

    2015-01-01

    Background To date there is no established consensus of assessment criteria for evaluating research ethics review. Methods We conducted a scoping review of empirical research assessing ethics review processes in order to identify common elements assessed, research foci, and research gaps to aid in the development of assessment criteria. Electronic searches of Ovid Medline, PsychInfo, and the Cochrane DSR, ACP Journal Club, DARE, CCTR, CMR, HTA, and NHSEED, were conducted. After de-duplication, 4234 titles and abstracts were reviewed. Altogether 4036 articles were excluded following screening of titles, abstracts and full text. A total of 198 articles included for final data extraction. Results Few studies originated from outside North America and Europe. No study reported using an underlying theory or framework of quality/effectiveness to guide study design or analyses. We did not identify any studies that had involved a controlled trial - randomised or otherwise – of ethics review procedures or processes. Studies varied substantially with respect to outcomes assessed, although tended to focus on structure and timeliness of ethics review. Discussion Our findings indicate a lack of consensus on appropriate assessment criteria, exemplified by the varied study outcomes identified, but also a fragmented body of research. To date research has been largely quantitative, with little attention given to stakeholder experiences, and is largely cross sectional. A lack of longitudinal research to date precludes analyses of change or assessment of quality improvement in ethics review. PMID:26225553

  7. 75 FR 55816 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2010-09-14

    ... DEPARTMENT OF THE INTERIOR Council of the Inspectors General on Integrity and Efficiency Senior..., each agency is required to establish one or more Senior Executive Service (SES) performance review boards. The purpose of these boards is to review and evaluate the initial appraisal of a senior executive...

  8. 78 FR 52995 - Senior Executive Service: Performance Review Board Members

    Science.gov (United States)

    2013-08-27

    ... SMALL BUSINESS ADMINISTRATION Senior Executive Service: Performance Review Board Members AGENCY: U. S. Small Business Administration. ACTION: Notice of Members for the FY 2014 Performance Review Board. SUMMARY: Title 5 U.S.C. 4314(c)(4) requires each agency to publish notification of the appointment of...

  9. 78 FR 75447 - Senior Executive Service; Departmental Performance Review Board

    Science.gov (United States)

    2013-12-11

    ... DEPARTMENT OF THE TREASURY Senior Executive Service; Departmental Performance Review Board AGENCY: Treasury Department. ACTION: Notice of members of the Departmental Performance Review Board (PRB). SUMMARY: Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members of the Departmental PRB...

  10. 77 FR 51523 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2012-08-24

    ... COUNCIL OF THE INSPECTORS GENERAL ON INTEGRITY AND EFFICIENCY Senior Executive Service Performance... required to establish one or more Senior Executive Service (SES) performance review boards. The purpose of these boards is to review and evaluate the initial appraisal of a senior executive's performance by the...

  11. 76 FR 64421 - Senior Executive Service: Performance Review Board Members

    Science.gov (United States)

    2011-10-18

    ... SMALL BUSINESS ADMINISTRATION Senior Executive Service: Performance Review Board Members AGENCY: U.S. Small Business Administration. ACTION: Notice of Members for the FY 2011 Performance Review Board. SUMMARY: Title 5 U.S.C. 4314(c)(4) requires each agency to publish notification of the appointment of...

  12. 77 FR 70204 - Senior Executive Service: Performance Review Board Members

    Science.gov (United States)

    2012-11-23

    ... SMALL BUSINESS ADMINISTRATION Senior Executive Service: Performance Review Board Members AGENCY: U.S. Small Business Administration. ACTION: Notice of Members for the FY 2012 Performance Review Board. SUMMARY: Title 5 U.S.C. 4314(c)(4) requires each agency to publish notification of the appointment of...

  13. 75 FR 71785 - Senior Executive Service: Performance Review Board Members

    Science.gov (United States)

    2010-11-24

    ... SMALL BUSINESS ADMINISTRATION Senior Executive Service: Performance Review Board Members AGENCY: U.S. Small Business Administration. ACTION: Notice of Members for the FY 2010 Performance Review Board. SUMMARY: Title 5 U.S.C. 4314(c)(4) requires each agency to publish notification of the appointment of...

  14. 78 FR 52513 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2013-08-23

    ... COUNCIL OF THE INSPECTORS GENERAL ON INTEGRITY AND EFFICIENCY Senior Executive Service Performance... Management, each agency is required to establish one or more Senior Executive Service (SES) performance review boards. The purpose of these boards is to review and evaluate the initial appraisal of a senior...

  15. 76 FR 69798 - Senior Executive Service; Departmental Performance Review Board

    Science.gov (United States)

    2011-11-09

    ... DEPARTMENT OF THE TREASURY Senior Executive Service; Departmental Performance Review Board AGENCY: Treasury Department. ACTION: Notice of members of the Departmental Performance Review Board (PRB). SUMMARY: Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members of the Departmental PRB...

  16. Ethics Requirement Score: new tool for evaluating ethics in publications

    Science.gov (United States)

    dos Santos, Lígia Gabrielle; Fonseca, Ana Carolina da Costa e; Bica, Claudia Giuliano

    2014-01-01

    Objective To analyze ethical standards considered by health-related scientific journals, and to prepare the Ethics Requirement Score, a bibliometric index to be applied to scientific healthcare journals in order to evaluate criteria for ethics in scientific publication. Methods Journals related to healthcare selected by the Journal of Citation Reports™ 2010 database were considered as experimental units. Parameters related to publication ethics were analyzed for each journal. These parameters were acquired by analyzing the author’s guidelines or instructions in each journal website. The parameters considered were approval by an Internal Review Board, Declaration of Helsinki or Resolution 196/96, recommendations on plagiarism, need for application of Informed Consent Forms with the volunteers, declaration of confidentiality of patients, record in the database for clinical trials (if applicable), conflict of interest disclosure, and funding sources statement. Each item was analyzed considering their presence or absence. Result The foreign journals had a significantly higher Impact Factor than the Brazilian journals, however, no significant results were observed in relation to the Ethics Requirement Score. There was no correlation between the Ethics Requirement Score and the Impact Factor. Conclusion Although the Impact Factor of foreigner journals was considerably higher than that of the Brazilian publications, the results showed that the Impact Factor has no correlation with the proposed score. This allows us to state that the ethical requirements for publication in biomedical journals are not related to the comprehensiveness or scope of the journal. PMID:25628189

  17. Ethics Requirement Score: new tool for evaluating ethics in publications.

    Science.gov (United States)

    Santos, Lígia Gabrielle dos; Costa e Fonseca, Ana Carolina da; Bica, Claudia Giuliano

    2014-01-01

    To analyze ethical standards considered by health-related scientific journals, and to prepare the Ethics Requirement Score, a bibliometric index to be applied to scientific healthcare journals in order to evaluate criteria for ethics in scientific publication. Journals related to healthcare selected by the Journal of Citation Reports™ 2010 database were considered as experimental units. Parameters related to publication ethics were analyzed for each journal. These parameters were acquired by analyzing the author's guidelines or instructions in each journal website. The parameters considered were approval by an Internal Review Board, Declaration of Helsinki or Resolution 196/96, recommendations on plagiarism, need for application of Informed Consent Forms with the volunteers, declaration of confidentiality of patients, record in the database for clinical trials (if applicable), conflict of interest disclosure, and funding sources statement. Each item was analyzed considering their presence or absence. The foreign journals had a significantly higher Impact Factor than the Brazilian journals, however, no significant results were observed in relation to the Ethics Requirement Score. There was no correlation between the Ethics Requirement Score and the Impact Factor. Although the Impact Factor of foreigner journals was considerably higher than that of the Brazilian publications, the results showed that the Impact Factor has no correlation with the proposed score. This allows us to state that the ethical requirements for publication in biomedical journals are not related to the comprehensiveness or scope of the journal.

  18. Will the new code help researchers to be more ethical?

    Science.gov (United States)

    Sieber, J E

    1994-11-01

    A code of ethics has 2 largely incompatible objectives: to set forth enforceable minimal standards of conduct and to teach about or invoke ethical conduct. The section of the new American Psychological Association code dealing with research ethics achieves the former to some degree. However, it neither provides needed education in the ethics of research nor states where the reader might turn for such information. The code is particularly deficient in the following areas: privacy and confidentiality; institutional review boards; deception; debriefing; data sharing; and research on marginal populations, on children and adolescents, and in organizational contexts. Suggestions are offered for providing a bibliographic resource, in hard copy and on-line, that would stimulate independent interest, scholarship, education, and research on research ethics.

  19. 78 FR 55244 - Senior Executive Service Performance Review Board; Membership

    Science.gov (United States)

    2013-09-10

    ... DEFENSE NUCLEAR FACILITIES SAFETY BOARD Senior Executive Service Performance Review Board... the membership of the Defense Nuclear Facilities Safety Board (DNFSB) Senior Executive Service (SES... rating of a senior executive's performance, the executive's response, and the higher level official's...

  20. 78 FR 63310 - Senior Executive Service; Fiscal Service Performance Review Board

    Science.gov (United States)

    2013-10-23

    ... Performance Review Board AGENCY: Bureau of the Fiscal Service, Treasury. ACTION: Notice. SUMMARY: This notice announces the appointment of the members of the Fiscal Service Performance Review Board (PRB) for the Bureau of the Fiscal Service (Fiscal Service). The PRB reviews the performance appraisals of career senior...

  1. Engineering Ethics Education : Its Necessity, Objectives, Methods, Current State, and Challenges

    Science.gov (United States)

    Fudano, Jun

    The importance of engineering ethics education has become widely recognized in the industrialized countries including Japan. This paper examines the background against which engineering ethics education is required, and reviews its objectives, methods, and challenges, as well as its current state. In pointing out important issues associated with the apparent acceptance and quantitative development of ethics education, especially after the establishment of the Japan Accreditation Board for Engineering Education in 1999, the author stresses that the most serious problem is the lack of common understanding on the objectives of engineering ethics education. As a strategy to improve the situation, the so-called “Ethics-across-the-Curriculum” approach is introduced. The author also claims that business/organization ethics which is consistent with engineering ethics should be promoted in Japan.

  2. Factors influencing the effectiveness of research ethics committees.

    Science.gov (United States)

    Schuppli, C A; Fraser, D

    2007-05-01

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

  3. Impact of ethical factors on job satisfaction among Korean nurses.

    Science.gov (United States)

    Jang, Yujin; Oh, Younjae

    2017-01-01

    Although numerous studies on job satisfaction among nurses have been conducted, there is a lack of research considering the ethical perspectives of leadership and organizational climate in job satisfaction. The purpose of this study was to clarify the impact of the ethical climate and ethical leadership as perceived by nurses on job satisfaction in South Korea. A descriptive and correlational study was conducted with a convenience sample of 263 nurses from four general hospitals in South Korea. Ethical considerations: This study was approved by the Institute Review Board of Hallym University before data collection. Job satisfaction was positively correlated with ethical climate and ethical leadership. The ethical climate in relationship with hospitals and people orientation leadership were influential factors in the level of job satisfaction among nurses. Organizations in the nursing environment should pay attention to improving the ethical climate with acceptable ethical norms in the workplace and nurse leaders should respect, support and genuinely care about their nurses in ethical concerns.

  4. 77 FR 65248 - Senior Executive Service; Public Debt Performance Review Board

    Science.gov (United States)

    2012-10-25

    ... Performance Review Board AGENCY: Bureau of the Public Debt, Treasury. ACTION: Notice. SUMMARY: This notice announces the appointment of the members of the Public Debt Performance Review Board (PRB) for the Bureau of the Public Debt (BPD). The PRB reviews the performance appraisals of career senior executives who are...

  5. 78 FR 73586 - Senior Executive Service Performance Review Board (PRB) and Executive Resources Board (ERB...

    Science.gov (United States)

    2013-12-06

    ...: Performance Review Board Leland L. Gardner, Chairman Rachel D. Campbell, Member Craig M. Keats, Member Lucille Marvin, Alternate Member Executive Resources Board Rachel D. Campbell, Chairman Lucille Marvin, Member Joseph H. Dettmar, Alternate Member These changes to the PRB and ERB membership are due to the departure...

  6. 77 FR 26790 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2012-05-07

    ... Safety Officer Medal of Valor Review Board AGENCY: Office of Justice Programs (OJP), Bureau of Justice... meeting (via conference call-in) of the Public Safety Officer Medal of Valor Review Board (``Board'') to... INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out those advisory functions...

  7. 14 CFR 21.125 - Production inspection system: Materials Review Board.

    Science.gov (United States)

    2010-01-01

    ... § 21.125 Production inspection system: Materials Review Board. Link to an amendment published at 74 FR... Materials Review Board action for at least two years. (b) The production inspection system required in § 21... 14 Aeronautics and Space 1 2010-01-01 2010-01-01 false Production inspection system: Materials...

  8. How not to argue against mandatory ethics review.

    Science.gov (United States)

    Hunter, David

    2013-08-01

    There is considerable controversy about the mandatory ethics review of research. This paper engages with the arguments offered by Murray Dyck and Gary Allen against mandatory review, namely, that this regulation fails to reach the standards that research ethics committees apply to research since it is harmful to the ethics of researchers, has little positive evidence base, leads to significant harms (through delaying valuable research) and distorts the nature of research. As these are commonplace arguments offered by researchers against regulation it is useful to assess their strength and the conclusion that they are taken to support, namely, that we ought to move back to a system of trust in researchers without compulsory regulation. Unfortunately, these arguments are at best weak and to some degree come into conflict in terms of supporting the desired conclusion.

  9. Ethical review boards are poor advocates for patient perspectives

    DEFF Research Database (Denmark)

    Masterton, Malin; Renberg, Tobias; Hansson, Mats G

    2014-01-01

    is to evaluate the risk−benefits of research, which are ultimately grounded in attitudes and values. From focus-group interviews with patients suffering from chronic inflammatory diseases, a postal questionnaire was developed and sent to patient members of the Swedish Rheumatism Association (n = 1195) and to all...... ERB board members in Sweden (N = 583). Response rates were 65 percent and the surveys were conducted in Jan−May 2011. Agreement across the groups included priority for medical research on diagnostic and early detection of disease. A key difference was expert and lay ERB members giving higher priority...... to basic research/research on lifestyle and prevention (primarily benefiting future patients), whereas patients prioritized research on daily function. On this significant point, lay members did not share the opinion of this patient group, indicating that they may be poor representatives for patients...

  10. Innovations in research ethics governance in humanitarian settings.

    Science.gov (United States)

    Schopper, Doris; Dawson, Angus; Upshur, Ross; Ahmad, Aasim; Jesani, Amar; Ravinetto, Raffaella; Segelid, Michael J; Sheel, Sunita; Singh, Jerome

    2015-02-26

    Médecins Sans Frontières (MSF) is one of the world's leading humanitarian medical organizations. The increased emphasis in MSF on research led to the creation of an ethics review board (ERB) in 2001. The ERB has encouraged innovation in the review of proposals and the interaction between the ERB and the organization. This has led to some of the advances in ethics governance described in this paper. We first update our previous work from 2009 describing ERB performance and then highlight five innovative practices: • A new framework to guide ethics review • The introduction of a policy exempting a posteriori analysis of routinely collected data • The preapproval of "emergency" protocols • General ethical approval of "routine surveys" • Evaluating the impact of approved studies. The new framework encourages a conversation about ethical issues, rather than imposing quasi-legalistic rules, is more engaged with the specific MSF research context and gives greater prominence to certain values and principles. Some of the innovations implemented by the ERB, such as review exemption or approval of generic protocols, may run counter to many standard operating procedures. We argue that much standard practice in research ethics review ought to be open to challenge and revision. Continued interaction between MSF researchers and independent ERB members has allowed for progressive innovations based on a trustful and respectful partnership between the ERB and the researchers. In the future, three areas merit particular attention. First, the impact of the new framework should be assessed. Second, the impact of research needs to be defined more precisely as a first step towards being meaningfully assessed, including changes of impact over time. Finally, the dialogue between the MSF ERB and the ethics committees in the study countries should be enhanced. We hope that the innovations in research ethics governance described may be relevant for other organisations carrying out

  11. The full spectrum of ethical issues in dementia care: systematic qualitative review.

    Science.gov (United States)

    Strech, Daniel; Mertz, Marcel; Knüppel, Hannes; Neitzke, Gerald; Schmidhuber, Martina

    2013-06-01

    Integrating ethical issues in dementia-specific training material, clinical guidelines and national strategy plans requires an unbiased awareness of all the relevant ethical issues. To determine systematically and transparently the full spectrum of ethical issues in clinical dementia care. We conducted a systematic review in Medline (restricted to English and German literature published between 2000 and 2011) and Google books (with no restrictions). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in clinical dementia care. The literature review retrieved 92 references that together mentioned a spectrum of 56 ethical issues in clinical dementia care. The spectrum was structured into seven major categories that consist of first- and second-order categories for ethical issues. The systematically derived spectrum of ethical issues in clinical dementia care presented in this paper can be used as training material for healthcare professionals, students and the public for raising awareness and understanding of the complexity of ethical issues in dementia care. It can also be used to identify ethical issues that should be addressed in dementia-specific training programmes, national strategy plans and clinical practice guidelines. Further research should evaluate whether this new genre of systematic reviews can be applied to the identification of ethical issues in other cognitive and somatic diseases. Also, the practical challenges in addressing ethical issues in training material, guidelines and policies need to be evaluated.

  12. Nurses' perception of ethical climate at a large academic medical center.

    Science.gov (United States)

    Lemmenes, Donna; Valentine, Pamela; Gwizdalski, Patricia; Vincent, Catherine; Liao, Chuanhong

    2016-09-07

    Nurses are confronted daily with ethical issues while providing patient care. Hospital ethical climates can affect nurses' job satisfaction, organizational commitment, retention, and physician collaboration. At a metropolitan academic medical center, we examined nurses' perceptions of the ethical climate and relationships among ethical climate factors and nurse characteristics. We used a descriptive correlational design and nurses (N = 475) completed Olson's Hospital Ethical Climate Survey. Data were analyzed using STATA. Approvals by the Nursing Research Council and Institutional Review Board were obtained; participants' rights were protected. Nurses reported an ethical climate total mean score of 3.22 ± 0.65 that varied across factors; significant differences were found for ethical climate scores by nurses' age, race, and specialty area. These findings contribute to what is known about ethical climate and nurses' characteristics and provides the foundation to develop strategies to improve the ethical climate in work settings. © The Author(s) 2016.

  13. Philosophy of organ donation: Review of ethical facets.

    Science.gov (United States)

    Dalal, Aparna R

    2015-06-24

    Transplantation ethics is a philosophy that incorporates systematizing, defending and advocating concepts of right and wrong conduct related to organ donation. As the demand for organs increases, it is essential to ensure that new and innovative laws, policies and strategies of increasing organ supply are bioethical and are founded on the principles of altruism and utilitarianism. In the field of organ transplantation, role of altruism and medical ethics values are significant to the welfare of the society. This article reviews several fundamental ethical principles, prevailing organ donation consent laws, incentives and policies related to the field of transplantation. The Ethical and Policy Considerations in Organ Donation after Circulatory Determination of Death outline criteria for death and organ retrieval. Presumed consent laws prevalent mostly in European countries maintain that the default choice of an individual would be to donate organs unless opted otherwise. Explicit consent laws require organ donation to be proactively affirmed with state registries. The Declaration of Istanbul outlines principles against organ trafficking and transplant tourism. World Health Organization's Guiding Principles on Human Cell, Tissue and Organ Transplantation aim at ensuring transparency in organ procurement and allocation. The ethics of financial incentives and non-financial incentives such as incorporation of non-medical criteria in organ priority allocation have also been reviewed in detail.

  14. 76 FR 67402 - Performance Review Board Appointments

    Science.gov (United States)

    2011-11-01

    ... Executive Service (SES), Senior Level (SL), and Scientific or Professional (ST) Performance Review Boards...; White, Dave. Research, Education and Economics (REE) Bartuska, Ann; Jacobs-Young, Chavonda; Woteki...

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

    Science.gov (United States)

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-03-01

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

  16. 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

  17. 77 FR 66793 - Senior Executive Service: Membership of Performance Review Board

    Science.gov (United States)

    2012-11-07

    ... AGENCY FOR INTERNATIONAL DEVELOPMENT Senior Executive Service: Membership of Performance Review Board ACTION: Notice. SUMMARY: This notice lists approved candidates who will comprise a standing roster for service on the Agency's 2012 and 2013 SES Performance Review Boards. The Agency will use this...

  18. Research Ethics Review and Aboriginal Community Values: Can the Two be Reconciled?

    Science.gov (United States)

    Glass, Kathleen Cranley; Kaufert, Joseph

    2007-06-01

    CONTEMPORARY RESEARCH ETHICS REVIEW COMMITTEES (RECs) are heavily influenced by the established academic or health care institutional frameworks in which they operate, sharing a cultural, methodological and ethical perspective on the conduct of research involving humans. The principle of autonomous choice carries great weight in what is a highly individualistic decision-making process in medical practice and research. This assumes that the best protection lies in the ability of patients or research participants to make competent, voluntary, informed choices, evaluating the risks and benefits from a personal perspective. Over the past two decades, North American and international indigenous researchers, policy makers and communities have identified key issues of relevance to them, but ignored by most institutional or university-based RECs. They critique the current research review structure, and propose changes on a variety of levels in an attempt to develop more community sensitive research ethics review processes. In doing so, they have emphasized recognition of collective rights including community consent. Critics see alternative policy guidelines and community-based review bodies as challenging the current system of ethics review. Some view them as reflecting a fundamental difference in values. In this paper, we explore these developments in the context of the political, legal and ethical frameworks that have informed REC review. We examine the process and content of these frameworks and ask how this contrasts with emerging Aboriginal proposals for community-based research ethics review. We follow this with recommendations on how current REC review models might accommodate the requirements of both communities and RECs.

  19. 76 FR 60473 - Membership of the Performance Review Board

    Science.gov (United States)

    2011-09-29

    ... Services Agency, Defense Logistics Agency, Defense Threat Reduction Agency, Missile Defense Agency, and... DEPARTMENT OF DEFENSE Office of the Secretary Membership of the Performance Review Board AGENCY: Office of the Secretary (OSD), Department of Defense (DoD). ACTION: Notice of board membership. SUMMARY...

  20. A Critical Review of Theories and Measures of Ethics-Related Leadership.

    Science.gov (United States)

    Zhu, Weichun; Zheng, Xiaoming; Riggio, Ronald E; Zhang, Xi

    2015-01-01

    This chapter reviews the different theoretical perspectives and measurements of ethics-related leadership models, including ethical leadership, transformational leadership, authentic leadership, servant leadership, spiritual leadership, and a virtues-based approach to leadership ethics. The similarities and differences among these theoretical models and measures to ethics-related leadership are discussed. © 2015 Wiley Periodicals, Inc., A Wiley Company.

  1. Enhancing professionalism using ethics education as part of a dental licensure board's disciplinary action. Part 2. Evidence of the process.

    Science.gov (United States)

    Bebeau, Muriel J

    2009-01-01

    Pretest scores were analyzed for 41 professionals referred for ethics assessment by a dental licensing board. Two were exempt from instruction based on pretest performance on five well-validated measures; 38 completed an individualized course designed to remediate deficiencies in ethical abilities. Statistically significant change (effect sizes ranging from .55 to 5.0) was observed for ethical sensitivity (DEST scores), moral reasoning (DIT scores), and role concept (essays and PROI scores). Analysis of the relationships between ability deficiencies and disciplinary actions supports the explanatory power of Rest's Four Component Model of Morality. Of particular interest is the way the model helped referred professionals deconstruct summary judgments about character and see them as capacities that can be further developed. The performance-based assessments, especially the DEST, were particularly useful in identifying shortcomings in ethical implementation. Referred practitioners highly valued the emphasis on ethical implementation, suggesting the importance of addressing what to do and say in ethically challenging cases. Finally, the required self-assessments of learning confirm the value of the process for professional renewal (i.e., a renewed commitment to professional ideals) and of enhanced abilities not only to reason about moral problems, but to implement actions.

  2. 76 FR 69797 - Senior Executive Service Departmental Offices Performance Review Board.

    Science.gov (United States)

    2011-11-09

    ... DEPARTMENT OF THE TREASURY Senior Executive Service Departmental Offices Performance Review Board. AGENCY: Treasury Department. ACTION: Notice of members of the Departmental Offices Performances Review Board. SUMMARY: Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members of the...

  3. A Systematic Literature Review of US Engineering Ethics Interventions.

    Science.gov (United States)

    Hess, Justin L; Fore, Grant

    2018-04-01

    Promoting the ethical formation of engineering students through the cultivation of their discipline-specific knowledge, sensitivity, imagination, and reasoning skills has become a goal for many engineering education programs throughout the United States. However, there is neither a consensus throughout the engineering education community regarding which strategies are most effective towards which ends, nor which ends are most important. This study provides an overview of engineering ethics interventions within the U.S. through the systematic analysis of articles that featured ethical interventions in engineering, published in select peer-reviewed journals, and published between 2000 and 2015. As a core criterion, each journal article reviewed must have provided an overview of the course as well as how the authors evaluated course-learning goals. In sum, 26 articles were analyzed with a coding scheme that included 56 binary items. The results indicate that the most common methods for integrating ethics into engineering involved exposing students to codes/standards, utilizing case studies, and discussion activities. Nearly half of the articles had students engage with ethical heuristics or philosophical ethics. Following the presentation of the results, this study describes in detail four articles to highlight less common but intriguing pedagogical methods and evaluation techniques. The findings indicate that there is limited empirical work on ethics education within engineering across the United States. Furthermore, due to the large variation in goals, approaches, and evaluation methods described across interventions, this study does not detail "best" practices for integrating ethics into engineering. The science and engineering education community should continue exploring the relative merits of different approaches to ethics education in engineering.

  4. 77 FR 49440 - Membership of the Performance Review Board

    Science.gov (United States)

    2012-08-16

    ..., Defense Security Cooperation Agency, Defense Threat Reduction Agency, Missile Defense Agency, and Pentagon... DEPARTMENT OF DEFENSE Office of the Secretary Membership of the Performance Review Board AGENCY: Office of the Secretary of Defense (OSD), DoD. ACTION: Notice of board membership. SUMMARY: This notice...

  5. 78 FR 52517 - Membership of the Performance Review Board

    Science.gov (United States)

    2013-08-23

    ..., Defense Security Cooperation Agency, Defense Threat Reduction Agency, Missile Defense Agency, and Pentagon... DEPARTMENT OF DEFENSE Office of the Secretary Membership of the Performance Review Board AGENCY: Office of the Secretary of Defense (OSD), DoD. ACTION: Notice of board membership. SUMMARY: This notice...

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

    Science.gov (United States)

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

    2011-07-01

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

  7. Controversies in nursing ethics: a historical review.

    Science.gov (United States)

    Olsen, D P

    1992-09-01

    The author critiques the dialectic between justice-based ethics and an ethic of caring from a historical perspective (by analogy with the dialectic between agape and friendship). Justice-based ethics have been problematic for nursing because of the decontextualized approach. The ethic of caring is problematic because caring, being contextual, is particularistic and therefore can be based on morally irrelevant factors, such as liking. There is a tradition of writing which seeks to reconcile the particularistic obligations of friendship with the moral duty to all others equally. Ideas from the following authors are reviewed for relevance to nursing: Aristotle, Aelred of Rievaulx, Augustine, John Cassian, Cicero, George Berkeley, Immanuel Kant, Michel de Montaigne, Jeremy Taylor and Max Weber. The authors concludes by noting that both sides of the dialectic are synthesized in the lived experience of individuals. A synthesis in thought is called for on this basis.

  8. Ethics and regulation in organ procurement research.

    Science.gov (United States)

    Ackerman, Terrence F; Winsett, Rebecca P

    2002-12-01

    This article explores the role of ethics and regulation in human research conducted by organ procurement agencies; basic ethical principles for human research are outlined. Organ procurement agencies are not required to observe federal regulations; however, voluntary adherence will ensure that procurement research is conducted according to current standards of ethical practice. Although most organ procurement research will qualify for exempt status, this determination should be made by an institutional review board. Even if studies qualify for exempt status, there is a moral presumption that informed consent should be sought, unless certain narrow conditions for waiver of consent are satisfied. Finally, when future research utilizing organ procurement records is anticipated, procurement coordinators should provide sufficiently detailed information to families about such plans to permit their advance informed consent to research activities.

  9. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    NARCIS (Netherlands)

    Hem, M.H.; Pedersen, R.; Norvoll, R.; Molewijk, A.C.

    2015-01-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five

  10. Progress in centralised ethics review processes: Implications for multi-site health evaluations.

    Science.gov (United States)

    Prosser, Brenton; Davey, Rachel; Gibson, Diane

    2015-04-01

    Increasingly, public sector programmes respond to complex social problems that intersect specific fields and individual disciplines. Such responses result in multi-site initiatives that can span nations, jurisdictions, sectors and organisations. The rigorous evaluation of public sector programmes is now a baseline expectation. For evaluations of large and complex multi-site programme initiatives, the processes of ethics review can present a significant challenge. However in recent years, there have been new developments in centralised ethics review processes in many nations. This paper provides the case study of an evaluation of a national, inter-jurisdictional, cross-sector, aged care health initiative and its encounters with Australian centralised ethics review processes. Specifically, the paper considers progress against the key themes of a previous five-year, five nation study (Fitzgerald and Phillips, 2006), which found that centralised ethics review processes would save time, money and effort, as well as contribute to more equitable workloads for researchers and evaluators. The paper concludes with insights for those charged with refining centralised ethics review processes, as well as recommendations for future evaluators of complex multi-site programme initiatives. Copyright © 2015 Elsevier Ltd. All rights reserved.

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

    Science.gov (United States)

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

    2011-06-01

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

  12. Ethical considerations in the study of online illness narratives: a qualitative review.

    Science.gov (United States)

    Heilferty, Catherine McGeehin

    2011-05-01

    This aim of the review was to describe differences in ethical approaches to research on Internet communication during illness and to report conclusions drawn relevant to a proposed narrative analysis of parent blogs of childhood illness. As the study of the online expression of illness experiences becomes more expansive, discussion of related ethical issues is central to promoting research trustworthiness and rigour. Ethical considerations are central to the patient-provider relationship. The EBSCO Host, CINAHL, Medline, Communication & Mass Media Complete, and Google Scholar databases were searched from January 1990 to September 2009 using the terms 'Internet research and ethics', 'Internet research, illness and ethics' and 'blog, Internet research and ethics'. Of the 4114 references found, 21 met the inclusion criteria for the review. The review was designed to be a comprehensive assessment of the concepts analysed and the qualitative research measures taken concerning ethics in Internet research across formats. Three main approaches to ethical conduct in Internet research on illness experiences were found: human subjects, representation and open source approaches. The personal and sensitive nature of online illness narratives demand their consideration in health care as 'human subjects' research. The best hope for ethical treatment of author-participants is the creation of a comprehensive plan for addressing any and all potential ethical conflicts that may arise in the collection, analysis and reporting of data, taking into consideration rapid changes in technology. © 2011 Blackwell Publishing Ltd.

  13. 78 FR 25476 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2013-05-01

    ... Safety Officer Medal of Valor Review Board AGENCY: Bureau of Justice Assistance (BJA), Department of...) of the Public Safety Officer Medal of Valor Review Board to consider a range of issues of [email protected] . SUPPLEMENTARY INFORMATION: The Public Safety Officer Medal of Valor Review Board carries out...

  14. 75 FR 54915 - Meeting of the Public Safety Officer Medal of Valor Review Board

    Science.gov (United States)

    2010-09-09

    ... Safety Officer Medal of Valor Review Board AGENCY: Office of Justice Programs (OJP), Justice. ACTION... Officer Medal of Valor Review Board to vote on recommendations for the 2009-2010 Medal of Valor... Public Safety Officer Medal of Valor Review Board carries out those advisory functions specified in 42 U...

  15. Ethical aspects of brain computer interfaces: a scoping review.

    Science.gov (United States)

    Burwell, Sasha; Sample, Matthew; Racine, Eric

    2017-11-09

    Brain-Computer Interface (BCI) is a set of technologies that are of increasing interest to researchers. BCI has been proposed as assistive technology for individuals who are non-communicative or paralyzed, such as those with amyotrophic lateral sclerosis or spinal cord injury. The technology has also been suggested for enhancement and entertainment uses, and there are companies currently marketing BCI devices for those purposes (e.g., gaming) as well as health-related purposes (e.g., communication). The unprecedented direct connection created by BCI between human brains and computer hardware raises various ethical, social, and legal challenges that merit further examination and discussion. To identify and characterize the key issues associated with BCI use, we performed a scoping review of biomedical ethics literature, analyzing the ethics concerns cited across multiple disciplines, including philosophy and medicine. Based on this investigation, we report that BCI research and its potential translation to therapeutic intervention generate significant ethical, legal, and social concerns, notably with regards to personhood, stigma, autonomy, privacy, research ethics, safety, responsibility, and justice. Our review of the literature determined, furthermore, that while these issues have been enumerated extensively, few concrete recommendations have been expressed. We conclude that future research should focus on remedying a lack of practical solutions to the ethical challenges of BCI, alongside the collection of empirical data on the perspectives of the public, BCI users, and BCI researchers.

  16. Ethics education for pediatric residents: a review of the literature

    Directory of Open Access Journals (Sweden)

    Raywat Deonandan

    2015-04-01

    Full Text Available Background: Ethics education and research on medical residents is needed because, unlike medical students or experienced doctors, medical residents have to perform multiple roles simultaneously – student, teacher and clinician – thus exposing them to unique ethical stressors.  In this paper we reviewed the literature concerning ethics education in postgraduate pediatrics training programs.  Our goal was not to simply describe educational strategies and programs, but also to explore measurements and experiences of current practices to address gaps in ethics education during residency. Method: We conducted a structured literature review to explore the extent of ethics education in pediatric residency programs.  Results:  Twelve relevant studies were found.  The studies suggest that existing training regimens are insufficient to meet the real life ethical challenges experienced in actual practice, particularly with respect to palliative care and the commission of clinical errors.  Conclusions: The increasing diversity of culture and beliefs in the clinical workplace is also serving to complicate educational needs. An interdisciplinary approach, spread over the entirety of a physician’s training, is a proposed solution worthy of more attention.

  17. 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

  18. Variability in research ethics review of cluster randomized trials: a scenario-based survey in three countries

    Science.gov (United States)

    2014-01-01

    Background Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently. Methods A web-based survey with closed- and open-ended questions was administered to research ethics chairs in Canada, the United States, and the United Kingdom. The survey presented three scenarios of CRTs involving cluster-level, professional-level, and individual-level interventions. For each scenario, a series of questions was posed with respect to the type of review required (full, expedited, or no review) and the identification of research subjects at cluster and individual levels. Results A total of 189 (35%) of 542 chairs responded. Overall, 144 (84%, 95% CI 79 to 90%) agreed or strongly agreed that there is a need for ethics guidelines for CRTs and 158 (92%, 95% CI 88 to 96%) agreed or strongly agreed that research ethics committees could be better informed about distinct ethical issues surrounding CRTs. There was considerable variability among research ethics chairs with respect to the type of review required, as well as the identification of research subjects. The cluster-cluster and professional-cluster scenarios produced the most disagreement. Conclusions Research ethics committees

  19. Where Hospital Boards Often Fail: Auditing Leadership Performance.

    Science.gov (United States)

    Friedman, Susan Y; Rabkin, Mitchell T

    2018-03-06

    Hospital boards address quality of care and patient safety as well as financial performance through long-accepted practices. By contrast, a hospital's administrative operations and institutional culture are not usually subject to such detailed scrutiny. Yet, despite a healthy bottom line and patient commendations, hospital personnel can be underperforming, burdened with poor morale, and suffering from less than optimal leadership, unwarranted inefficiency, and ethically questionable management practices. The resulting employee dissatisfaction or disengagement can affect productivity, quality, turnover, innovation, patient and donor attraction and retention, public image, etc., and can be missed by an unsuspecting board. While boards do not scrutinize most administrative operations, they do examine financial performance, through review of the independent auditor's Management Letter. Designed to help the chief financial officer (CFO) improve the efficiency and integrity of the hospital's financial systems and to recommend improvements to the board for implementation (rather than to assess the CFO's performance), the Management Letter has no equal with respect to a comparable evaluation of the hospital's administrative performance and workplace culture. When, as is often the case, there is only superficial review of the chief executive officer, the board has no source of analysis or recommendations to improve the hospital's institutional environment. In this Invited Commentary, the authors suggest a methodology to provide such a review, leading to a Leadership Letter, and discuss its utility for both non-profit and for-profit organizations.

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

    Science.gov (United States)

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

    2017-10-01

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

  1. 12 CFR 265.3 - Board review of delegated actions.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Board review of delegated actions. 265.3 Section 265.3 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL... for determination if the delegee considers it appropriate because of the importance or complexity of...

  2. Ethical aspects on rare diseases.

    Science.gov (United States)

    Barrera, Luis A; Galindo, Gilberto Cely

    2010-01-01

    In this chapter we discuss several of the most relevant subjects related to ethics on Rare Diseases. Some general aspects are discussed such as the socio-psychological problems that confront the patients and their families that finally lead to marginalization and exclusion of patients affected by these diseases from the health programs, even in wealthy countries. Then we address problems related to diagnosis and some ethical aspects of newborn screening, prenatal, pre-implantation diagnosis and reference centers, as well as some conditions that should be met by the persons and institutions performing such tasks. Alternatives of solutions for the most critical situations are proposed. Subsequently the orphan drugs subject is discussed not only from the availability point of view, prizes, industrial practices, and purchasing power in developed and developing societies. The research related to rare disease in children and other especially vulnerable conditions, the need for informed consent, review boards or ethics comities, confidentiality of the information, biobanks and pharmacogenetics are discussed.

  3. ISPOR Code of Ethics 2017 (4th Edition).

    Science.gov (United States)

    Santos, Jessica; Palumbo, Francis; Molsen-David, Elizabeth; Willke, Richard J; Binder, Louise; Drummond, Michael; Ho, Anita; Marder, William D; Parmenter, Louise; Sandhu, Gurmit; Shafie, Asrul A; Thompson, David

    2017-12-01

    As the leading health economics and outcomes research (HEOR) professional society, ISPOR has a responsibility to establish a uniform, harmonized international code for ethical conduct. ISPOR has updated its 2008 Code of Ethics to reflect the current research environment. This code addresses what is acceptable and unacceptable in research, from inception to the dissemination of its results. There are nine chapters: 1 - Introduction; 2 - Ethical Principles respect, beneficence and justice with reference to a non-exhaustive compilation of international, regional, and country-specific guidelines and standards; 3 - Scope HEOR definitions and how HEOR and the Code relate to other research fields; 4 - Research Design Considerations primary and secondary data related issues, e.g., participant recruitment, population and research setting, sample size/site selection, incentive/honorarium, administration databases, registration of retrospective observational studies and modeling studies; 5 - Data Considerations privacy and data protection, combining, verification and transparency of research data, scientific misconduct, etc.; 6 - Sponsorship and Relationships with Others (roles of researchers, sponsors, key opinion leaders and advisory board members, research participants and institutional review boards (IRBs) / independent ethics committees (IECs) approval and responsibilities); 7 - Patient Centricity and Patient Engagement new addition, with explanation and guidance; 8 - Publication and Dissemination; and 9 - Conclusion and Limitations. Copyright © 2017 International Society for Pharmacoeconomics and Outcomes Research (ISPOR). Published by Elsevier Inc. All rights reserved.

  4. Board monitoring of the chief financial officer: A review and research agenda

    OpenAIRE

    Uhde, David Alexander; Klarner, Patricia; Tuschke, Anja

    2017-01-01

    markdownabstract__Research Question/Issue:__ Research on how boards govern individual top management team (TMT) members, i.e., senior executives aside from the CEO, is still scarce and fragmented. In this study, we review extant research on board monitoring of the Chief Financial Officer (CFO) - an increasingly influential actor at the top of the firm - synthesize it, and propose an integrative future research agenda on board governing of the CFO. __Research Findings/Insights:__ Our review of...

  5. Ethics of health policy and systems research: a scoping review of the literature.

    Science.gov (United States)

    Pratt, Bridget; Paul, Amy; Hyder, Adnan A; Ali, Joseph

    2017-07-01

    Health policy and systems research (HPSR) is increasingly funded and undertaken as part of health system strengthening efforts worldwide. HPSR ethics is also a relatively new and emerging field, with numerous normative and descriptive questions that have largely not been considered. Normative questions include what ethical principles and values should guide HPSR. Descriptive questions include what ethical concerns arise when conducting HPSR. A small but growing body of scholarly work characterizes the various ethics issues inherent in HPSR. Towards informing the future development of ethics guidance for HPSR, a scoping review was undertaken to: (1) identify the range of ethics issues relevant to the conduct of HPSR-with a deliberate (though not exclusive) focus on low- and middle-income country settings and (2) describe existing guidance on key ethics issues relevant to HPSR. Using the Cochrane methods as a basis, the review identified formal and informal literature on HPSR ethics by searching the following databases: PubMed's Medline, Embase, Global Health, Scopus, WHO Global Health Regional Libraries, LILACs, OpenDOAR and Bielefeld Academic Search Engine. In total, 11 062 documents were identified from the formal (10 519) and informal (543) literature. One hundred and seven of these documents (formal 99 and informal 8) met at least one inclusion criterion and underwent thematic analysis. Ethical issues in four main categories were identified: upholding autonomy, identifying and balancing risks and benefits, justice and determination of ethical review requirements. The review indicated that the ethical values behind HPSR place an emphasis on its contributing to the reduction of health disparities. Unsurprisingly then, numerous ethical concerns relating to justice arise in HPSR. However, the majority of existing guidance focuses on obtaining or waiving informed consent and, thus, appears to be insufficient for HPSR. A list of priority ethics issues in HPSR in

  6. The ethical desirability of moral bioenhancement: A review of reasons

    NARCIS (Netherlands)

    J. Specker (Jona); F. Focquaert (Farah); K. Raus (Kasper); S. Sterckx (Sigrid); M.H.N. Schermer (Maartje)

    2014-01-01

    textabstractBackground: The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and

  7. Ethical issues in pragmatic randomized controlled trials: a review of the recent literature identifies gaps in ethical argumentation.

    Science.gov (United States)

    Goldstein, Cory E; Weijer, Charles; Brehaut, Jamie C; Fergusson, Dean A; Grimshaw, Jeremy M; Horn, Austin R; Taljaard, Monica

    2018-02-27

    Pragmatic randomized controlled trials (RCTs) are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question

  8. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Science.gov (United States)

    2010-04-01

    ... report by the Ethics Law Division. 4.34 Section 4.34 Housing and Urban Development Office of the... Funding Decisions § 4.34 Review of Inspector General's report by the Ethics Law Division. After receipt of the Inspector General's report, the Ethics Law Division shall review the facts and circumstances of...

  9. Conflict of interest - serious issue on publication ethics for Indian medical journals.

    Science.gov (United States)

    Das, Kusal K; Vallabha, Tejaswini; Ray, Jaydeb; Murthy, P S N

    2013-01-01

    There are several vested interest lies on research publication hence the editorial policy is the sole important factor to control and regulate ethical publications in medical sciences especially on 'conflict of interest' issue. The study was aimed to assess on awareness of 'conflict of interest' issue in medical research and publication among the editorial staff, peer reviewers and authors of Indian medical journals. Total 61 authors who have published research articles recently in Indian medical journals from 2008-2012, 56 peer reviewers who reviewed the manuscripts during same period and 35 editorial board members of various Indian medical journals were assessed by questionnaire and telephone interview regarding their understanding and knowledge on 'conflict of interest' issue for ethical publication. Only seven (12%) of the authors knew about the 'conflict of interest' issue and 11 (19%) of the medical authors have just heard about it. Out of 12% of authors who knew 'conflict of interest' issue only 15% provided that statement to the journals. Among the peer reviewers only 17 (30%) knew about 'conflict of interest' of which 51 (91.5%) stated that they do not bother about this issue while reviewing the manuscripts. But interestingly 42 (75%) of the peer reviewers confessed that they had a bias on the topics written by their friends or students. Among the editorial board members of Indian medical journals only 14 (25%) have any idea on 'conflict of interest issue'. Results clearly shows poor understanding of 'conflict of interest' like important ethical issue among Indian medical scientists or journals.

  10. Academic ethical awareness among undergraduate nursing students.

    Science.gov (United States)

    Cho, Ok-Hee; Hwang, Kyung-Hye

    2017-01-01

    Academic ethical awareness is an important aspect especially for nursing students who will provide ethical nursing care to patients in future or try to tread the path of learning toward professional acknowledgement in nursing scholarship. The purpose of this study was to explore academic ethical awareness and its related characteristics among undergraduate nursing students. This study commenced the survey with cross-sectional, descriptive questions and enrolled convenient samples of 581 undergraduate nursing students from three universities in South Korea. It was investigated with structured questionnaires including general characteristics and academic ethical awareness related. Ethical considerations: This study was reviewed and approved by the Institutional Review Board at National University. Academic ethical awareness was the highest regarding behaviors violating the respect or confidentiality of patients and cheating on exams, while it was the lowest for inappropriate behaviors in class. From the result of general characteristics difference, male students showed higher score than female students in relative; first-year students showed higher score than other year students; the higher score was rated from students who were highly satisfied with their major than the other not satisfied with their major; and students with low academic stress showed higher ethical awareness score than persons with higher stress. Personal behaviors were rated with low ethical awareness in relative, but items related to public rules and actual effects on patients or others were rated with higher score. Nursing satisfaction and academic stress are main factors on ethical awareness. To improve overall ethical awareness level of nursing students, it is required to provide more education about the importance of personal behaviors in class and need to improve the understanding of how it will be connected with future situation and effect.

  11. 77 FR 60116 - Human Studies Review Board; Notification of a Public Meeting

    Science.gov (United States)

    2012-10-02

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0718; FRL-9736-4] Human Studies Review Board; Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to...

  12. 77 FR 74004 - Human Studies Review Board; Notification of a Public Meeting

    Science.gov (United States)

    2012-12-12

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0892; FRL-9761-4] Human Studies Review Board; Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to...

  13. Celebrating 25 years of Syncrude`s Geotechnical Review Board

    Energy Technology Data Exchange (ETDEWEB)

    McKenna, G.

    1998-09-01

    An historical review of Syncrude`s Geotechnical Review Board (GRB) was presented, relating some of the successes of the Board over the past 25 years since its establishment. A list of the type of challenges faced by Syncrude where the GRB`s guidance and counselling proved to be critical, is also included. The GRB was established in the 1970s to help Syncrude manage its geotechnical-based risks and to enhance its long-range chances to be successful in oil sands mining. Mining oil sands was breaking new ground back then, consequently, the geotechnical risks were largely unknown and the potential of heavy financial losses were great. Under such circumstances making the right decisions in dealing with geotechnical risks was vital to success. The fact that 25 years later Syncrude is still operating on the basis of those earlier decisions and still relies heavily on the expertise of the Board for recommendations and guidance is a testimony to the value of the GRB to Syncrude`s operations. The GRB`s success is credited to the Board`s world-wide expertise, objectivity, focus on the big issues, risk-based approach and its excellent working partnership with Syncrude employees. Dragline mining and tailings management are the areas that benefited the most from the Board`s involvement, but the Board has been involved in every facet of geotechnical-based risk management. Some of the geotechnical challenges that the GRB has helped Syncrude to overcome include dam construction of muskeg foundation, heavy foundations on gassy and temperature-sensitive soils, coring and testing of gassy/expansive oil sands and haul roads, highwall design utilizing locked sands, winter construction of large fluid retaining embankments and characterization and management of fluid fine tailings. 3 refs., 1 graph, 3 figs.

  14. Ethical responsibilities of pharmacists when selling complementary medicines: a systematic review.

    Science.gov (United States)

    Salman Popattia, Amber; Winch, Sarah; La Caze, Adam

    2018-04-01

    The widespread sale of complementary medicines in community pharmacy raises important questions regarding the responsibilities of pharmacists when selling complementary medicines. This study reviews the academic literature that explores a pharmacist's responsibilities when selling complementary medicines. International Pharmaceutical Abstracts, Embase, PubMed, Cinahl, PsycINFO and Philosopher's index databases were searched for articles written in English and published between 1995 and 2017. Empirical studies discussing pharmacists' practices or perceptions, consumers' expectations and normative studies discussing ethical perspectives or proposing ethical frameworks related to pharmacists' responsibilities in selling complementary medicines were included in the review. Fifty-eight studies met the inclusion criteria. The majority of the studies discussing the responsibilities of pharmacists selling complementary medicines had an empirical focus. Pharmacists and consumers identified counselling and ensuring safe use of complementary medicines as the primary responsibilities of pharmacists. No formal ethical framework is explicitly employed to describe the responsibilities of pharmacists selling complementary medicines. To the degree any ethical framework is employed, a number of papers implicitly rely on principlism. The studies discussing the ethical perspectives of selling complementary medicines mainly describe the ethical conflict between a pharmacist's business and health professional role. No attempt is made to provide guidance on appropriate ways to resolve the conflict. There is a lack of explicit normative advice in the existing literature regarding the responsibilities of pharmacists selling complementary medicines. This review identifies the need to develop a detailed practice-specific ethical framework to guide pharmacists regarding their responsibilities when selling complementary medicines. © 2018 Royal Pharmaceutical Society.

  15. 78 FR 5516 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2013-01-25

    ... OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION Senior Executive Service Performance Review Board Membership AGENCY: Occupational Safety and Health Review Commission. ACTION: Annual notice. SUMMARY: Notice... established a Senior Executive Service PRB. The PRB reviews and evaluates the initial appraisal of a senior...

  16. 75 FR 14214 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2010-03-24

    ... OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION Senior Executive Service Performance Review Board Membership AGENCY: Occupational Safety and Health Review Commission. ACTION: Annual notice. SUMMARY: Notice... established a Senior Executive Service PRB. The PRB reviews and evaluates the initial appraisal of a senior...

  17. 76 FR 39926 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2011-07-07

    ... OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION Senior Executive Service Performance Review Board Membership AGENCY: Occupational Safety and Health Review Commission. ACTION: Annual notice. SUMMARY: Notice... established a Senior Executive Service PRB. The PRB reviews and evaluates the initial appraisal of a senior...

  18. 76 FR 81998 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2011-12-29

    ... OCCUPATIONAL SAFETY AND HEALTH REVIEW COMMISSION Senior Executive Service Performance Review Board Membership AGENCY: Occupational Safety and Health Review Commission. ACTION: Annual notice. SUMMARY: Notice... established a Senior Executive Service PRB. The PRB reviews and evaluates the initial appraisal of a senior...

  19. The Impact of Ethics Review on a Research-Led University Curriculum: Results of a Qualitative Study in Australia.

    Science.gov (United States)

    Wynn, L L

    2016-04-01

    In the human sciences, a student research-centered pedagogy is constrained by institutional ethics review, yet there is little research on the impact of ethics review on research-led teaching. This article documents a range of ways that Australian universities are responding to ethics review of undergraduate human research. Forty teachers and administrators were interviewed at 14 universities using purposive sampling to document the range of ways teachers are avoiding ethics review or incorporating it into their curriculum. Some reported halting undergraduate research or evading ethics review, regarding it as meaningless bureaucracy divorced from actual ethical thinking. Those who incorporated ethics review into student research did so by collaborating with administrators. Institutions can facilitate research-led teaching by designing dedicated forms and decentralized review procedures for student research. © The Author(s) 2016.

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

    Science.gov (United States)

    Zizzo, Natalie; Bell, Emily; Racine, Eric

    2016-01-01

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

  1. Ethical issues in using Twitter for public health surveillance and research: developing a taxonomy of ethical concepts from the research literature.

    Science.gov (United States)

    Conway, Mike

    2014-12-22

    The rise of social media and microblogging platforms in recent years, in conjunction with the development of techniques for the processing and analysis of "big data", has provided significant opportunities for public health surveillance using user-generated content. However, relatively little attention has been focused on developing ethically appropriate approaches to working with these new data sources. Based on a review of the literature, this study seeks to develop a taxonomy of public health surveillance-related ethical concepts that emerge when using Twitter data, with a view to: (1) explicitly identifying a set of potential ethical issues and concerns that may arise when researchers work with Twitter data, and (2) providing a starting point for the formation of a set of best practices for public health surveillance through the development of an empirically derived taxonomy of ethical concepts. We searched Medline, Compendex, PsycINFO, and the Philosopher's Index using a set of keywords selected to identify Twitter-related research papers that reference ethical concepts. Our initial set of queries identified 342 references across the four bibliographic databases. We screened titles and abstracts of these references using our inclusion/exclusion criteria, eliminating duplicates and unavailable papers, until 49 references remained. We then read the full text of these 49 articles and discarded 36, resulting in a final inclusion set of 13 articles. Ethical concepts were then identified in each of these 13 articles. Finally, based on a close reading of the text, a taxonomy of ethical concepts was constructed based on ethical concepts discovered in the papers. From these 13 articles, we iteratively generated a taxonomy of ethical concepts consisting of 10 top level categories: privacy, informed consent, ethical theory, institutional review board (IRB)/regulation, traditional research vs Twitter research, geographical information, researcher lurking, economic value

  2. 78 FR 57383 - Human Studies Review Board; Notification of a Public Meeting

    Science.gov (United States)

    2013-09-18

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2013-0626; FRL-9900-98-ORD] Human Studies Review Board; Notification of a Public Meeting AGENCY: U.S. Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to...

  3. 76 FR 80938 - Human Studies Review Board; Notification of a Public Meeting

    Science.gov (United States)

    2011-12-27

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0954; FRL-9611-6] Human Studies Review Board; Notification of a Public Meeting AGENCY: U.S. Environmental Protection Agency. ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the...

  4. In regard to the change of the editorial board and the advisory board of the Bosnian Journal of Basic Medical Sciences

    Directory of Open Access Journals (Sweden)

    Bakir Mehić

    2014-02-01

    Full Text Available The most vital part of a scientific journal is the Editorial board and Advisory board. So, it is never good that the composition of these boards lasts longer than 2-3 years.With the first number of BJBMS in 2014, a new composition of the Editorial board and Advisory Board of this journal was published. They consist of eminent scientists with adequate qualifications from nine countries and who can actively contribute to the good management of the journal and its further development. Their tasks will be: -Supporting and promotion of the journal (being true ambassadors of the journal,-Writing editorials, reviews and commentaries on works from the field of their expertise,-Giving opinions and suggestions on the management and policy of the journal, with the timely identification of the upcoming challenges. Commitment to upholding the ethics of publishing with impartiality and confidentiality, the fight against plagiarism and multiple or simultaneous publication of articles will remain a priority in the work of the Editorial Board and Advisory Board of BJBMS. Also, the newly appointed boards will continue to work in the way of protection of copyright for authors who were victims of plagiarism. In this sense, the editor in chief, together with the Editorial Board will take measures in accordance with the guidelines of the Committee for Ethics in publishing [1].Quality assurance in publishing and also in BJBMS is focused on the detection of forged data, images, and plagiarized articles. In its future work Editorial Board of BJBMS is obliged to pay attention to supporting academic integrity, ensuring the integrity of academic records and intellectual property. This latter implies: -Request for evidence of ethics for the approved research, that is, authors will be asked to prove that they obtained the consent of the patient for the study or in the case of experiments on animals, which methods were used so the animals would not suffer?-Ensuring that

  5. Ethical issues in obesity prevention for school children: a systematic qualitative review.

    Science.gov (United States)

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2017-12-01

    Planning and conducting preventive measures against obesity for school children is beset with ethical issues which should be known to make well-informed decisions. The goal of this study was to provide a comprehensive spectrum of these ethical issues by means of a systematic review. In this context, the study also assesses the value of different search strategies for ethical literature in public health. Literature was searched in Medline, EBSCO and others. Three different search strategies with varied scopes were applied and their output was compared. Qualitative content analysis was used for extracting and categorizing ethical issues. 109 publications (published from 1995 to 2015) were finally included. The qualitative analysis resulted in 60 potentially relevant ethical issues. The three search strategies showed substantial differences regarding their search results. The presented spectrum provides an initial evidence base for dealing with ethical issues adequately. The findings of the study further suggest that a broader scope is more fruitful for systematic reviews on ethical issues in the field of public health.

  6. Time required for institutional review board review at one Veterans Affairs medical center.

    Science.gov (United States)

    Hall, Daniel E; Hanusa, Barbara H; Stone, Roslyn A; Ling, Bruce S; Arnold, Robert M

    2015-02-01

    Despite growing concern that institutional review boards (IRBs) impose burdensome delays on research, little is known about the time required for IRB review across different types of research. To measure the overall and incremental process times for IRB review as a process of quality improvement. After developing a detailed process flowchart of the IRB review process, 2 analysts abstracted temporal data from the records pertaining to all 103 protocols newly submitted to the IRB at a large urban Veterans Affairs medical center from June 1, 2009, through May 31, 2011. Disagreements were reviewed with the principal investigator to reach consensus. We then compared the review times across review types using analysis of variance and post hoc Scheffé tests after achieving normally distributed data through logarithmic transformation. Calendar days from initial submission to final approval of research protocols. Initial IRB review took 2 to 4 months, with expedited and exempt reviews requiring less time (median [range], 85 [23-631] and 82 [16-437] days, respectively) than full board reviews (median [range], 131 [64-296] days; P = .008). The median time required for credentialing of investigators was 1 day (range, 0-74 days), and review by the research and development committee took a median of 15 days (range, 0-184 days). There were no significant differences in credentialing or research and development times across review types (exempt, expedited, or full board). Of the extreme delays in IRB review, 80.0% were due to investigators' slow responses to requested changes. There were no systematic delays attributable to the information security officer, privacy officer, or IRB chair. Measuring and analyzing review times is a critical first step in establishing a culture and process of continuous quality improvement among IRBs that govern research programs. The review times observed at this IRB are substantially longer than the 60-day target recommended by expert panels

  7. 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

  8. Ethics review of health research on human participants in South Africa.

    Science.gov (United States)

    van Wyk, Christa

    2010-06-01

    In terms of South African legislation, all health research on human participants must be submitted to an accredited research ethics committee for independent ethics review. Health research covers a broad spectrum of research, including clinical trials. This article sets out the ethical-legal framework for the functioning and composition of such committees. It also deals with the newly created National Health Research Ethics Council, which registers and audits health research ethics committees. Special attention is given to the conduct of clinical trials. In conclusion, it is submitted that the National Health Act, the Draft Regulations Relating to Research on Human Subjects, and two sets of ethical guidelines adopted by the Department of Health provide a much needed and coherent ethical-legal framework for research in South Africa.

  9. A systematic review of ethical issues in vaccine studies involving pregnant women.

    Science.gov (United States)

    Beeler, Jennifer A; Lambach, Philipp; Fulton, T Roice; Narayanan, Divya; Ortiz, Justin R; Omer, Saad B

    2016-08-02

    Immunization during pregnancy can provide protection for mother and child. However, there have been only a limited number of studies documenting the efficacy and safety of this strategy. To determine the extent and nature of subject matter related to ethics in maternal immunization by systematically documenting the spectrum of ethical issues in vaccine studies involving pregnant women. We conducted a systematic literature review of published works pertaining to vaccine and therapeutic studies involving pregnant women through searches of PubMed, EMBASE, Web of Science, the Cochrane Database, and ClinicalTrials.gov. We selected literature meeting the inclusion criteria published between 1988 and June 2014. We systematically abstracted subject matter pertaining to ethical issues in immunization studies during pregnancy. Immunization-specific ethical issues were matched and grouped into major categories and subcategories. Seventy-seven published articles met the inclusion criteria. Published articles reported findings on data that had been collected in 26 countries, the majority of which were classified as high-income or upper-middle-income nations according to World Bank criteria. Review of these publications produced 60 immunization-specific ethical issues, grouped into six major categories. Notably, many studies demonstrated limited acknowledgment of key ethical issues including the rights and welfare of participants. Additionally, there was no discussion pertaining to the ethics of program implementation, including integration of maternal immunization programs into existing routine immunization programs. This review of ethical issues in immunization studies of pregnant women can be used to help inform future vaccine trials in this important population. Consistent documentation of these ethical issues by investigators will facilitate a broader and more nuanced discussion of ethics in immunization of pregnant women - offering new and valuable insights for programs

  10. Supporting ethical competence of nurses during recruitment and performance reviews - the role of the nurse leader.

    Science.gov (United States)

    Poikkeus, Tarja; Leino-Kilpi, Helena; Katajisto, Jouko

    2014-09-01

    The aim of this study was to analyse how nurse leaders support the ethical competence of nurses during recruitment and performance reviews. Ethical competence of nurses refers to ethical behaviour and action requiring ethical knowledge and reflection. Nurse leaders have a key role in supporting the ethical competence of nurses, but little is known about just how this should be done. The data were collected using a structured questionnaire and analysed statistically. The target sample consisted of nurse leaders (n = 198) from two university hospitals in two healthcare districts in Finland. Nurse leaders support the ethical competence of nurses more often during performance reviews than during recruitment. During recruitment, nurse leaders ensure the ethical behaviour and knowledge of nurses to varying degrees. During performance reviews, nurse leaders ensure that nurses meet the requirements for collegiality and comply with ethical guidelines and that they do so according to nursing values and principles. There seems to be a need to examine and improve support for the ethical competence of nurses, both during recruitment and performance reviews. Future priorities should include a focus on supporting the ethical knowledge, reflection and behaviour of nurses. An important aspect in terms of supporting the ethical competence of nurses has to do with the ethical knowledge and education of nurse leaders and organisational policies or recommendations for ethical support. © 2013 John Wiley & Sons Ltd.

  11. Book Review: CFP Board Financial Planning Competency Handbook

    Directory of Open Access Journals (Sweden)

    Jorge Ruiz-Menjivar

    2015-07-01

    Full Text Available The CFP Board Financial Planning Competency Handbook (2013 is reviewed as a resource that extends beyond financial planning to other helping professionals who work with money related issues.

  12. Ethical issues in the use of in-depth interviews: literature review and discussion

    OpenAIRE

    Allmark, Peter; Boote, Jonathan; Chambers, E.; Clarke, Amanda; McDonnell, A.; Thompson, Andrew; Tod, Angela

    2009-01-01

    This paper reports a literature review on the topic of ethical issues in in-depth interviews. The review returned three types of article: general discussion, issues in particular studies, and studies of interview-based research ethics. Whilst many of the issues discussed in these articles are generic to research ethics, such as confidentiality, they often had particular manifestations in this type of research. For example, privacy was a significant problem as interviews sometimes probe unexpe...

  13. From global bioethics to ethical governance of biomedical research collaborations.

    Science.gov (United States)

    Wahlberg, Ayo; Rehmann-Sutter, Christoph; Sleeboom-Faulkner, Margaret; Lu, Guangxiu; Döring, Ole; Cong, Yali; Laska-Formejster, Alicja; He, Jing; Chen, Haidan; Gottweis, Herbert; Rose, Nikolas

    2013-12-01

    One of the features of advanced life sciences research in recent years has been its internationalisation, with countries such as China and South Korea considered 'emerging biotech' locations. As a result, cross-continental collaborations are becoming common generating moves towards ethical and legal standardisation under the rubric of 'global bioethics'. Such a 'global', 'Western' or 'universal' bioethics has in turn been critiqued as an imposition upon resource-poor, non-Western or local medical settings. In this article, we propose that a different tack is necessary if we are to come to grips with the ethical challenges that inter-continental biomedical research collaborations generate. In particular we ask how national systems of ethical governance of life science research might cope with increasingly global research collaborations with a focus on Sino-European collaboration. We propose four 'spheres' - deliberation, regulation, oversight and interaction - as a helpful way to conceptualise national systems of ethical governance. Using a workshop-based mapping methodology (workshops held in Beijing, Shanghai, Changsha, Xian, Shenzen and London) we identified three specific ethical challenges arising from cross-continental research collaborations: (1) ambiguity as to which regulations are applicable; (2) lack of ethical review capacity not only among ethical review board members but also collaborating scientists; (3) already complex, researcher-research subject interaction is further complicated when many nationalities are involved. Copyright © 2013 Elsevier Ltd. All rights reserved.

  14. 39 CFR 3.7 - Information furnished to Board-program review.

    Science.gov (United States)

    2010-07-01

    ...) To enable the Board to review the effectiveness of the Postal Service's equal employment opportunity... service or reducing the cost of postal operations. (d) Management shall furnish to the Board: information... directly to the core business function of the Postal Service. This information shall be provided to the...

  15. 76 FR 63351 - Senior Executive Service; Financial Management Service Performance Review Board (PRB)

    Science.gov (United States)

    2011-10-12

    ... DEPARTMENT OF THE TREASURY Senior Executive Service; Financial Management Service Performance Review Board (PRB) AGENCY: Financial Management Service, Treasury. ACTION: Notice. SUMMARY: This notice announces the appointment of members to the Financial Management Service (FMS) Performance Review Board (PRB...

  16. 77 FR 60177 - Senior Executive Service; Financial Management Service Performance Review Board (PRB)

    Science.gov (United States)

    2012-10-02

    ... DEPARTMENT OF THE TREASURY Senior Executive Service; Financial Management Service Performance Review Board (PRB) AGENCY: Financial Management Service, Treasury. ACTION: Notice. SUMMARY: This notice announces the appointment of members to the Financial Management Service (FMS) Performance Review Board (PRB...

  17. Ethics a la Dilbert.

    Science.gov (United States)

    Hager, Elizabeth A.

    1998-01-01

    Describes the Ethics Challenge Game (developed by Lockheed Martin Corp. and free to educators), which is a board game based on the Dilbert comic strip character that provides realistic scenarios for discussion of ethical behavior in various business/workplace situations. Describes the game, offers comments on faculty reactions after playing the…

  18. A narrative review of undergraduate peer-based healthcare ethics teaching.

    Science.gov (United States)

    Hindmarch, Thomas; Allikmets, Silvia; Knights, Felicity

    2015-12-12

    This study explores the literature in establishing the value of undergraduate peer-based healthcare ethics teaching as an educational methodology. A narrative review of the literature concerning peer-based ethics teaching was conducted. MEDLINE, EMBASE, CINAHL, SCOPUS databases, and the Cochrane Library, were systematically searched for studies of peer-based ethics or professionalism teaching. Selected studies related peer-based teaching to ethics education outcomes. Ten publications were identified. Selected studies were varied in their chosen intervention methodology and analysis. Collectively, the identified studies suggest peer-based ethics education is an effective and valued educational methodology in training healthcare professionals. One paper suggests peer-based ethics teaching has advantages over traditional didactic methods. Peer-based ethics teaching also receives positive feedback from student participants. However, the limited literature base demonstrates a clear need for more evaluation of this pedagogy. The current literature base suggests that undergraduate peer based healthcare ethics teaching is valuable in terms of efficacy and student satisfaction. We conclude that the medical community should invest in further study in order to capitalise upon the potential of peer-based ethics teaching in undergraduate healthcare education.

  19. 76 FR 59697 - Human Studies Review Board (HSRB); Notification of a Public Meeting

    Science.gov (United States)

    2011-09-27

    ... public meeting of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0693; FRL-9472-4] Human Studies Review Board (HSRB); Notification of a Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice...

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

    Science.gov (United States)

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

    2017-01-01

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

  1. 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)

    2013-01-01

    Background 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. Methods 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. Results 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. Conclusion Delays in the approval or non

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

    Science.gov (United States)

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

    2016-04-01

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

  3. Non-equivalent stringency of ethical review in the Baltic States: a sign of a systematic problem in Europe?

    Science.gov (United States)

    Gefenas, E; Dranseika, V; Cekanauskaite, A; Hug, K; Mezinska, S; Peicius, E; Silis, V; Soosaar, A; Strosberg, M

    2011-01-01

    We analyse the system of ethical review of human research in the Baltic States by introducing the principle of equivalent stringency of ethical review, that is, research projects imposing equal risks and inconveniences on research participants should be subjected to equally stringent review procedures. We examine several examples of non-equivalence or asymmetry in the system of ethical review of human research: (1) the asymmetry between rather strict regulations of clinical drug trials and relatively weaker regulations of other types of clinical biomedical research and (2) gaps in ethical review in the area of non-biomedical human research where some sensitive research projects are not reviewed by research ethics committees at all. We conclude that non-equivalent stringency of ethical review is at least partly linked to the differences in scope and binding character of various international legal instruments that have been shaping the system of ethical review in the Baltic States. Therefore, the Baltic example could also serve as an object lesson to other European countries which might be experiencing similar problems. PMID:20606000

  4. Ethical issues in public health surveillance: a systematic qualitative review.

    Science.gov (United States)

    Klingler, Corinna; Silva, Diego Steven; Schuermann, Christopher; Reis, Andreas Alois; Saxena, Abha; Strech, Daniel

    2017-04-04

    Public health surveillance is not ethically neutral and yet, ethics guidance and training for surveillance programmes is sparse. Development of ethics guidance should be based on comprehensive and transparently derived overviews of ethical issues and arguments. However, existing overviews on surveillance ethics are limited in scope and in how transparently they derived their results. Our objective was accordingly to provide an overview of ethical issues in public health surveillance; in addition, to list the arguments put forward with regards to arguably the most contested issue in surveillance, that is whether to obtain informed consent. Ethical issues were defined based on principlism. We assumed an ethical issue to arise in surveillance when a relevant normative principle is not adequately considered or two principles come into conflict. We searched Pubmed and Google Books for relevant publications. We analysed and synthesized the data using qualitative content analysis. Our search strategy retrieved 525 references of which 83 were included in the analysis. We identified 86 distinct ethical issues arising in the different phases of the surveillance life-cycle. We further identified 20 distinct conditions that make it more or less justifiable to forego informed consent procedures. This is the first systematic qualitative review of ethical issues in public health surveillance resulting in a comprehensive ethics matrix that can inform guidelines, reports, strategy papers, and educational material and raise awareness among practitioners.

  5. Continuing education requirements among State Occupational Therapy Regulatory Boards in the United States of America

    Directory of Open Access Journals (Sweden)

    Savannah R. Hall

    2016-10-01

    Full Text Available Purpose The purpose of this study is to compare and contrast the contents of each state’s occupational therapy (OT regulatory board requirements regarding licensees’ acquisition of continuing education units in the United States of America. Methods Data related to continuing education requirements from each OT regulatory board of all 50 states and the District of Columbia in the United States were reviewed and categorized by two reviewers. Analysis was conducted based on the categorization of the continuing education requirements and activities required, allowed, and not allowed/not mentioned for continuing education units. Results Findings revealed non-uniformity and inconsistency of continuing education requirements for licensure renewal between OT regulatory boards and was coupled with lack of specific criteria for various continuing education activities. Continuing education requirements were not tailored to meet the needs of individual licensee’s current and anticipated professional role and job responsibilities, with a negative bias towards presentation and publication allowed for continuing education units. Few boards mandated continuing education topics on ethics related to OT practice within each renewal cycle. Conclusion OT regulatory boards should move towards unifying the reporting format of continuing education requirements across all states to reduce ambiguity and to ensure licensees are equipped to provide ethical and competent practice. Efforts could be made to enact continuing education requirements specific to the primary role of a particular licensee. Finally, assigning the amount of continuing education credits to be awarded for different activities should be based on research evidence rather than arbitrary determination.

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

    Science.gov (United States)

    Farajkhoda, Tahmineh

    2017-01-01

    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

  7. 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

  8. 76 FR 17970 - Board Meeting: April 27, 2011-Amherst, New York; the U.S. Nuclear Waste Technical Review Board...

    Science.gov (United States)

    2011-03-31

    ... the 2008-9 study on Quantitative Risk Assessment of the State Licensed Radioactive Waste Disposal Area... of vitrified high-level radioactive waste (HLW); determination of waste classification of the melter... NUCLEAR WASTE TECHNICAL REVIEW BOARD Board Meeting: April 27, 2011--Amherst, New York; the U.S...

  9. Pediatric clinical drug trials in low-income countries: key ethical issues.

    Science.gov (United States)

    MacLeod, S M; Knoppert, D C; Stanton-Jean, M; Avard, D

    2015-02-01

    Potential child participants in clinical research trials in low-income countries are often vulnerable because of poverty, high morbidity and mortality, inadequate education, and varied local cultural norms. However, vulnerability by itself must not be accepted as an obstacle blocking children from the health benefits that may accrue as an outcome of sound clinical research. As greater emphasis is placed on evidence-based treatment of children, it should be anticipated that there will be a growing call for agreement on principles to guide clinical investigations in low-income countries. There is now general acceptance of the view that children must be protected from non-evidence-based interventions and from substandard treatments. The questions remaining relate to how best to stimulate clinical research activity that will serve the needs of infants, children, and youth in developing countries and how best to assign priority to ethically sound research that will meet their clinical requirements. In low-income countries, 39 % of citizens are 13 years of age or younger, and consequently it is certain that clinical investigations of some new therapeutic products will be conducted there more frequently. This review offers some suggestions for approaches that will help to achieve more effective ethical consideration, including (1) improving the quality of research ethics boards; (2) fostering collaborative partnerships among important stakeholders; (3) making concerted efforts to build capacity; (4) improving the quality of the consent and waiver process; and (5) developing improved governance for harmonized ethics platforms. Continuing support by international organizations is required to sustain the establishment and maintenance of stronger research ethics boards to protect children enrolled in clinical trials. This review underscores the importance of developing a culture of solidarity and true partnership between developed and low-income country organizations, which

  10. What methods do reviews of normative ethics literature use for search, selection, analysis, and synthesis? In-depth results from a systematic review of reviews.

    Science.gov (United States)

    Mertz, Marcel; Strech, Daniel; Kahrass, Hannes

    2017-12-19

    (Semi-)systematic approaches to finding, analysing, and synthesising ethics literature on medical topics are still in their infancy. However, our recent systematic review showed that the rate of publication of such (semi-)systematic reviews has increased in the last two decades. This is not only true for reviews of empirical ethics literature, but also for reviews of normative ethics literature. In the latter case, there is currently little in the way of standards and guidance available. Therefore, the methods and reporting strategies of such reviews vary greatly. The purpose of the follow-up study we present was to obtain deeper methodological insight into the ways reviews of normative literature are actually conducted and to analyse the methods used. Our search in the PubMed, PhilPapers, and Google Scholar databases led to the identification of 183 reviews of ethics literature published between 1997 and 2015, of which 84 were identified as reviews of normative and mixed literature. Qualitative content analysis was used to extract and synthesise descriptions of search, selection, quality appraisal, analysis, and synthesis methods. We further assessed quantitatively how often certain methods (e.g. search strategies, data analysis procedures) were used by the reviews. The overall reporting quality varies among the analysed reviews and was generally poor even for major criteria regarding the search and selection of literature. For example, only 24 (29%) used a PRISMA flowchart. Also, only 55 (66%) reviews mentioned the information unit they sought to extract, and 12 (14%) stated an ethical approach as the theoretical basis for the analysis. Interpretable information on the synthesis method was given by 47 (60%); the most common methods applied were qualitative methods commonly used in social science research (83%). Reviews which fail to provide sufficient relevant information to readers have reduced methodological transparency regardless of actual methodological

  11. Inadequacy of ethical conduct and reporting of stepped wedge cluster randomized trials: Results from a systematic review.

    Science.gov (United States)

    Taljaard, Monica; Hemming, Karla; Shah, Lena; Giraudeau, Bruno; Grimshaw, Jeremy M; Weijer, Charles

    2017-08-01

    Background/aims The use of the stepped wedge cluster randomized design is rapidly increasing. This design is commonly used to evaluate health policy and service delivery interventions. Stepped wedge cluster randomized trials have unique characteristics that complicate their ethical interpretation. The 2012 Ottawa Statement provides comprehensive guidance on the ethical design and conduct of cluster randomized trials, and the 2010 CONSORT extension for cluster randomized trials provides guidelines for reporting. Our aims were to assess the adequacy of the ethical conduct and reporting of stepped wedge trials to date, focusing on research ethics review and informed consent. Methods We conducted a systematic review of stepped wedge cluster randomized trials in health research published up to 2014 in English language journals. We extracted details of study intervention and data collection procedures, as well as reporting of research ethics review and informed consent. Two reviewers independently extracted data from each trial; discrepancies were resolved through discussion. We identified the presence of any research participants at the cluster level and the individual level. We assessed ethical conduct by tabulating reporting of research ethics review and informed consent against the presence of research participants. Results Of 32 identified stepped wedge trials, only 24 (75%) reported review by a research ethics committee, and only 16 (50%) reported informed consent from any research participants-yet, all trials included research participants at some level. In the subgroup of 20 trials with research participants at cluster level, only 4 (20%) reported informed consent from such participants; in 26 trials with individual-level research participants, only 15 (58%) reported their informed consent. Interventions (regardless of whether targeting cluster- or individual-level participants) were delivered at the group level in more than two-thirds of trials; nine trials (28

  12. 76 FR 37353 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Business Ethics Compliance...

    Science.gov (United States)

    2011-06-27

    ...; Submission for OMB Review; Contractor Business Ethics Compliance Program and Disclosure Requirements AGENCIES... contractor business ethics compliance program and disclosure requirements. Public comments are particularly... Information Collection 9000- 0164, Contractor Business Ethics Compliance Program and Disclosure Requirements...

  13. Exploring how IBCLCs manage ethical dilemmas: a qualitative study

    Directory of Open Access Journals (Sweden)

    Noel-Weiss Joy

    2012-07-01

    Full Text Available Abstract Background Professional health care practice should be based on ethical decisions and actions. When there are competing ethical standards or principles, one must choose between two or more competing options. This study explores ethical dilemmas experienced by International Board Certified Lactation Consultants. Methods The investigator interviewed seven International Board Certified Lactation Consultants and analyzed the interviews using qualitative research methods. Results "Staying Mother-Centred" emerged as the overall theme. It encompassed six categories that emerged as steps in managing ethical dilemmas: 1 recognizing the dilemma; 2 identifying context; 3 determining choices; 4 strategies used; 5 results and choices the mother made; and 6 follow-up. The category, "Strategies used", was further analyzed and six sub-themes emerged: building trust; diffusing situations; empowering mothers; finding balance; providing information; and setting priorities. Conclusions This study provides a framework for understanding how International Board Certified Lactation Consultants manage ethical dilemmas. Although the details of their stories changed, the essence of the experience remained quite constant with the participants making choices and acting to support the mothers. The framework could be the used for further research or to develop tools to support IBCLCs as they manage ethical dilemmas and to strengthen the profession with a firm ethics foundation.

  14. Exploring how IBCLCs manage ethical dilemmas: a qualitative study

    Science.gov (United States)

    2012-01-01

    Background Professional health care practice should be based on ethical decisions and actions. When there are competing ethical standards or principles, one must choose between two or more competing options. This study explores ethical dilemmas experienced by International Board Certified Lactation Consultants. Methods The investigator interviewed seven International Board Certified Lactation Consultants and analyzed the interviews using qualitative research methods. Results "Staying Mother-Centred" emerged as the overall theme. It encompassed six categories that emerged as steps in managing ethical dilemmas: 1) recognizing the dilemma; 2) identifying context; 3) determining choices; 4) strategies used; 5) results and choices the mother made; and 6) follow-up. The category, "Strategies used", was further analyzed and six sub-themes emerged: building trust; diffusing situations; empowering mothers; finding balance; providing information; and setting priorities. Conclusions This study provides a framework for understanding how International Board Certified Lactation Consultants manage ethical dilemmas. Although the details of their stories changed, the essence of the experience remained quite constant with the participants making choices and acting to support the mothers. The framework could be the used for further research or to develop tools to support IBCLCs as they manage ethical dilemmas and to strengthen the profession with a firm ethics foundation. PMID:22824376

  15. Peer Review in Controversial Topics—A Case Study of 9/11

    Directory of Open Access Journals (Sweden)

    John D. Wyndham

    2017-06-01

    Full Text Available Beginning with an historical reminiscence, this paper examines the peer review process as experienced by authors currently seeking publication of their research in a highly controversial area. A case study of research into the events of 9/11 (11 September 2001 illustrates some of the problems in peer review arising from undue influences based on financial and political considerations. The paper suggests that ethical failures, rather than flaws in the process itself, are mainly responsible for perceived problems. The way forward lies in improved ethics and a more open process. In addition, editorial review boards and peer review strategies would help to improve the ethics of peer review in general.

  16. 5 CFR 5301.105 - Restrictions applicable to Members of the National Science Board.

    Science.gov (United States)

    2010-01-01

    ... National Science Board. 5301.105 Section 5301.105 Administrative Personnel NATIONAL SCIENCE FOUNDATION SUPPLEMENTAL STANDARDS OF ETHICAL CONDUCT FOR EMPLOYEES OF THE NATIONAL SCIENCE FOUNDATION § 5301.105...) by the Chairman of the National Science Board or by the Designated Agency Ethics Official. (3) A...

  17. Nuclear medicine board review. Questions and answers for self-assessment. 2. ed.

    International Nuclear Information System (INIS)

    Goldfarb, C.R.; Ongseng, F.; Zuckier, L.S.; Karam, M.; Cooper, J.A.

    2007-01-01

    This book provides thorough preparation for certification examinations by the American Board of Radiology (Nuclear Medicine section and Special Competency), the American Board of Nuclear Medicine, and the America Board of Nuclear Cardiology. More than 1,780 questions test the reader's knowledge of the diagnostic and therapeutic uses of radionuclides, single-photon applications, and positron emission tomography (PET). Features: - A convenient question and answer format, in which questions appear on the left and answers on the right, allowing the reader to rapidly quiz and review. - New chapters addressing the emergence of PET/CT. - Measurements provided in both American standard and SI metric units. Ideal for board exam preparation, this concise text is an up-to-date question and answer review for the most important topics in nuclear medicine. (orig.)

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

    Science.gov (United States)

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

    2007-05-01

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

  19. Recommendations for the ethical use and design of artificial intelligent care providers.

    Science.gov (United States)

    Luxton, David D

    2014-09-01

    This paper identifies and reviews ethical issues associated with artificial intelligent care providers (AICPs) in mental health care and other helping professions. Specific recommendations are made for the development of ethical codes, guidelines, and the design of AICPs. Current developments in the application of AICPs and associated technologies are reviewed and a foundational overview of applicable ethical principles in mental health care is provided. Emerging ethical issues regarding the use of AICPs are then reviewed in detail. Recommendations for ethical codes and guidelines as well as for the development of semi-autonomous and autonomous AICP systems are described. The benefits of AICPs and implications for the helping professions are discussed in order to weigh the pros and cons of their use. Existing ethics codes and practice guidelines do not presently consider the current or the future use of interactive artificial intelligent agents to assist and to potentially replace mental health care professionals. AICPs present new ethical issues that will have significant ramifications for the mental health care and other helping professions. Primary issues involve the therapeutic relationship, competence, liability, trust, privacy, and patient safety. Many of the same ethical and philosophical considerations are applicable to use and design of AICPs in medicine, nursing, social work, education, and ministry. The ethical and moral aspects regarding the use of AICP systems must be well thought-out today as this will help to guide the use and development of these systems in the future. Topics presented are relevant to end users, AI developers, and researchers, as well as policy makers and regulatory boards. Published by Elsevier B.V.

  20. 75 FR 70002 - Senior Executive Service Performance Review Board; Membership

    Science.gov (United States)

    2010-11-16

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9227-3] Senior Executive Service Performance Review Board... review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior...

  1. 76 FR 70131 - Senior Executive Service Performance Review Board; Membership

    Science.gov (United States)

    2011-11-10

    ... ENVIRONMENTAL PROTECTION AGENCY [FRL-9489-5] Senior Executive Service Performance Review Board... review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any recommendations to the appointment authority relative to the performance of the senior...

  2. Ethical Challenges when Interviewing Close Relatives Together – An Integrative Review

    DEFF Research Database (Denmark)

    Voltelen, Barbara; Konradsen, Hanne; Østergaard, Birte

    and search terms. Results In total 17 articles were located, 9 containing relevant information about dyadic interviewing, only dealing subtly with questions of ethics. Another 8 articles addressed both dyadic interviewing and ethical considerations. Findings were divided into three different themes......Background and purpose Interviewing two interrelated persons (or more) simultaneously might pose different ethical considerations than interviewing just one person. Such ethical considerations, however, remain largely undescribed in literature, challenging the researcher who wishes to conduct them....... The purpose of this study is to describe the special ethical perspectives concerning joint interviews with interrelated persons. Method An integrative review was performed. A search was conducted in Pub Med, Cinahl, Philosophers Index and Academic Search from 1980 -2014. Data corpus from the 17 articles...

  3. Ethical issues in the use of in-depth interviews: literature review and discussion\\ud

    OpenAIRE

    Allmark, P.; Boote, J.; Chambers, E.; Clarke, A.; McDonnell, A.; Thompson, A.R.; Tod, A.

    2009-01-01

    This paper reports a literature review on the topic of ethical issues in in-depth interviews. The review returned three\\ud types of article: general discussion, issues in particular studies, and studies of interview-based research ethics. Whilst\\ud many of the issues discussed in these articles are generic to research ethics, such as confidentiality, they often had particular\\ud manifestations in this type of research. For example, privacy was a significant problem as interviews sometimes\\ud ...

  4. 75 FR 70268 - Submission for OMB Review; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

    Science.gov (United States)

    2010-11-17

    ... each time the person contacts the helpdesk. Frequency of Response: Once, except for the SAE Reviewer... Statistical Reviewer Form 20 1 2 hours 40 (Attachment 6J). Board Members CIRB SAE Reviewer Worksheet 10 15 30... 4140-01-P ...

  5. 75 FR 59704 - Office of Management; Performance Review Board Membership

    Science.gov (United States)

    2010-09-28

    ... FURTHER INFORMATION CONTACT: Mary Beth Pultz, Director, Executive Resources Team, Human Resources Services... DEPARTMENT OF EDUCATION Office of Management; Performance Review Board Membership AGENCY... Department of Education for 2010 is composed of career and non-career senior executives. The PRB reviews and...

  6. 77 FR 66909 - Notification of Contact Information Change for the Benghazi Accountability Review Board

    Science.gov (United States)

    2012-11-07

    ... DEPARTMENT OF STATE [Public Notice 8080] Notification of Contact Information Change for the Benghazi Accountability Review Board SUMMARY: On October 1, 2012, the Department of State announced the formation of the Benghazi Accountability Review Board (ARB) in the Federal Register (FR Doc. 2012-24504...

  7. 5 CFR 1633.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Science.gov (United States)

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Cross-reference to employee ethical... ethical conduct standards and financial disclosure regulations. Employees of the Federal Retirement Thrift Investment Board (Board) are subject to the executive branch-wide Standards of Ethical conduct at 5 CFR part...

  8. The Full Spectrum of Clinical Ethical Issues in Kidney Failure. Findings of a Systematic Qualitative Review.

    Science.gov (United States)

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2016-01-01

    When treating patients with kidney failure, unavoidable ethical issues often arise. Current clinical practice guidelines some of them, but lack comprehensive information about the full range of relevant ethical issues in kidney failure. A systematic literature review of such ethical issues supports medical professionalism in nephrology, and offers a solid evidential base for efforts that aim to improve ethical conduct in health care. To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. A systematic review in Medline (publications in English or German between 2000 and 2014) and Google Books (with no restrictions) was conducted. Ethical issues were identified by qualitative text analysis and normative analysis. The literature review retrieved 106 references that together mentioned 27 ethical issues in clinical care of kidney failure. This set of ethical issues was structured into a matrix consisting of seven major categories and further first and second-order categories. The systematically-derived matrix helps raise awareness and understanding of the complexity of ethical issues in kidney failure. It can be used to identify ethical issues that should be addressed in specific training programs for clinicians, clinical practice guidelines, or other types of policies dealing with kidney failure.

  9. 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

  10. [Ethical problems experienced by nurses in primary health care: integrative literature review].

    Science.gov (United States)

    Nora, Carlise Rigon Dalla; Zoboli, Elma Lourdes Campos Pavone; Vieira, Margarida

    2015-03-01

    The aim of this study is to identify ethical problems experienced by nurses in primary health care and resources for coping based on publications on the subject. An integrative literature review was performed between the months of October and November 2013, using the databases: BDTD, CINAHL, LILACS, MEDLINE, Biblioteca Cochrane, PubMed, RCAAP and SciELO. Articles, dissertations and theses published in Portuguese, English and Spanish were included, totalling 31 studies published from 1992 to 2013. This analysis resulted in four categories: ethical problems in the relationship between team members, ethical problems in the relationship with the user, ethical problems in health services management and resources for coping with ethical problems. Results showed that nurses need to be prepared to face ethical problems, emphasizing the importance of ethics education during the education process before and during professional practice to enhance the development of ethical sensitivity and competence for problem resolution.

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

    Science.gov (United States)

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

    2017-03-01

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

  12. [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.

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

    Science.gov (United States)

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

    2018-03-06

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

  14. 78 FR 44563 - Senior Executive Service (SES) Performance Review Board

    Science.gov (United States)

    2013-07-24

    ... FEDERAL LABOR RELATIONS AUTHORITY Senior Executive Service (SES) Performance Review Board AGENCY... Management, one or more PRBs. The PRB shall review and evaluate the initial appraisal of a senior executive's performance by the supervisor, along with any response by the senior executive, and make recommendations to...

  15. Ethical problems experienced by nurses in primary health care: integrative literature review

    Directory of Open Access Journals (Sweden)

    Carlise Rigon Dalla Nora

    Full Text Available The aim of this study is to identify ethical problems experienced by nurses in primary health care and resources for coping based on publications on the subject. An integrative literature review was performed between the months of October and November 2013, using the databases: BDTD, CINAHL, LILACS, MEDLINE, Biblioteca Cochrane, PubMed, RCAAP and SciELO. Articles, dissertations and theses published in Portuguese, English and Spanish were included, totalling 31 studies published from 1992 to 2013. This analysis resulted in four categories: ethical problems in the relationship between team members, ethical problems in the relationship with the user, ethical problems in health services management and resources for coping with ethical problems. Results showed that nurses need to be prepared to face ethical problems, emphasizing the importance of ethics education during the education process before and during professional practice to enhance the development of ethical sensitivity and competence for problem resolution.

  16. Evaluating clinical ethics support in mental healthcare: a systematic literature review.

    Science.gov (United States)

    Hem, Marit Helene; Pedersen, Reidar; Norvoll, Reidun; Molewijk, Bert

    2015-06-01

    A systematic literature review on evaluation of clinical ethics support services in mental healthcare is presented and discussed. The focus was on (a) forms of clinical ethics support services, (b) evaluation of clinical ethics support services, (c) contexts and participants and (d) results. Five studies were included. The ethics support activities described were moral case deliberations and ethics rounds. Different qualitative and quantitative research methods were utilized. The results show that (a) participants felt that they gained an increased insight into moral issues through systematic reflection; (b) there was improved cooperation among multidisciplinary team members; (c) it was uncertain whether clinical ethics support services led to better patient care; (d) the issue of patient and client participation is complex; and (e) the implementation process is challenging. Clinical ethics support services have mainly been studied through the experiences of the participating facilitators and healthcare professionals. Hence, there is limited knowledge of whether and how various types of clinical ethics support services influence the quality of care and how patients and relatives may evaluate clinical ethics support services. Based on the six excluded 'grey zone articles', in which there was an implicit focus on ethics reflection, other ways of working with ethical reflection in practice are discussed. Implementing and evaluating clinical ethics support services as approaches to clinical ethics support that are more integrated into the development of good practice are in focus. In order to meet some of the shortcomings of the field of clinical ethics support services, a research project that aims to strengthen ethics support in the mental health services, including patients' and caregivers' views on ethical challenges, is presented. © The Author(s) 2014.

  17. Ethical Considerations Regarding the Use of Smart Home Technologies for Older Adults: An Integrative Review.

    Science.gov (United States)

    Chung, Jane; Demiris, George; Thompson, Hilaire J

    2016-01-01

    With the wide adoption and use of smart home applications, there is a need for examining ethical issues regarding smart home use at the intersection of aging, technology, and home environment. The purpose of this review is to provide an overview of ethical considerations and the evidence on these ethical issues based on an integrative literature review with regard to the utilization of smart home technologies by older adults and their family members. REVIEW DESIGN AND METHODS: We conducted an integrative literature review of the scientific literature from indexed databases (e. g., MEDLINE, CINAHL, and PsycINFO). The framework guiding this review is derived from previous work on ethical considerations related to telehealth use for older adults and smart homes for palliative care. Key ethical issues of the framework include privacy, informed consent, autonomy, obtrusiveness, equal access, reduction in human touch, and usability. Six hundred and thirty-five candidate articles were identified between the years 1990 and 2014. Sixteen articles were included in the review. Privacy and obtrusiveness issues appear to be the most important factors that can affect smart home technology adoption. In addition, this article recommends that stigmatization and reliability and maintenance of the system are additional factors to consider. When smart home technology is used appropriately, it has the potential to improve quality of life and maintain safety among older adults, ultimately supporting the desire of older adults for aging in place. The ability to respond to potential ethical concerns will be critical to the future development and application of smart home technologies that aim to enhance safety and independence.

  18. Nurses on health care governing boards: An integrative review.

    Science.gov (United States)

    Sundean, Lisa J; Polifroni, E Carol; Libal, Kathryn; McGrath, Jacqueline M

    Nurses are key change agents in health care; yet, nurses have not been sufficiently engaged on boards to shape decision making. Without an equal voice in the boardroom, nurses cannot fulfill their professional obligation to society. The purpose of this study was to understand the progression in research focus and recommendations over time about nurses on boards (NOB), identify research gaps, and make research/practice recommendations. An integrative review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines (2009) for data evaluation and analysis. Eleven studies (six quantitative, three qualitative, and two quasi-mixed methods) were included in the review. The focus/recommendations of research about NOB have changed from passive observation to action-oriented inquiry that considers nurse expertise and value but lacks a coordinated approach to advance board appointments for nurses. A systematic approach to the research is needed to advance NOB as key agents in health care transformation and social justice. Copyright © 2017 Elsevier Inc. All rights reserved.

  19. 75 FR 68669 - Senior Executive Service; Departmental Performance Review Board

    Science.gov (United States)

    2010-11-08

    ... DEPARTMENT OF THE TREASURY Senior Executive Service; Departmental Performance Review Board AGENCY: Treasury Department. ACTION: Notice. SUMMARY: Pursuant to 5 U.S.C. 4314(c)(4), this notice announces the appointment of members of the Departmental PRB. The purpose of this PRB is to review and make recommendations...

  20. Board monitoring of the chief financial officer: A review and research agenda

    NARCIS (Netherlands)

    D.A. Uhde (David Alexander); P. Klarner (Patricia); A. Tuschke (Anja)

    2017-01-01

    markdownabstract__Research Question/Issue:__ Research on how boards govern individual top management team (TMT) members, i.e., senior executives aside from the CEO, is still scarce and fragmented. In this study, we review extant research on board monitoring of the Chief Financial Officer (CFO) - an

  1. A Review of Contemporary Ethical Decision-Making Models for Mental Health Professionals

    Science.gov (United States)

    Francis, Perry C.

    2015-01-01

    Mental health professionals are faced with increasingly complex ethical decisions that are impacted by culture, personal and professional values, and the contexts in which they and their clients inhabit. This article presents the reasons for developing and implementing multiple ethical decision making models and reviews four models that address…

  2. Ethics and Transgenic Crops: a Review

    OpenAIRE

    Robinson, Jonathan

    1999-01-01

    This article represents a review of some of the ethical dilemmas that have arisen as a result of the development and deployment of transgenic crop plants. The potential for transgenic crops to alleviate human hunger and the possible effects on human health are discussed. Risks and benefits to the environment resulting from genetic engineering of crops for resistance to biotic and abiotic stresses are considered, in addition to effects on biodiversity. The socio-economic impacts and distributi...

  3. Ethical review of research on human subjects at Unilever: reflections on governance.

    Science.gov (United States)

    Sheehan, Mark; Marti, Vernon; Roberts, Tony

    2014-07-01

    This article considers the process of ethical review of research on human subjects at a very large multinational consumer products company. The commercial context of this research throws up unique challenges and opportunities that make the ethics of the process of oversight distinct from mainstream medical research. Reflection on the justification of governance processes sheds important, contrasting light on the ethics of governance of other forms and context of research. © 2013 John Wiley & Sons Ltd.

  4. 77 FR 21109 - Senior Executive Service; Appointment of Members to the Performance Review Board

    Science.gov (United States)

    2012-04-09

    ... DEPARTMENT OF LABOR Office of the Secretary Senior Executive Service; Appointment of Members to the Performance Review Board Title 5 U.S.C. 4314(c)(4) provides that Notice of the Appointment of an individual to serve as a member of the Performance Review Board of the Senior Executive Service shall be...

  5. Ethical Issues in Radiology Journalism, Peer Review, and Research.

    Science.gov (United States)

    Katz, Douglas S; Gardner, James B; Hoffmann, Jason C; Patlas, Michael N; Bhargava, Puneet; Moshiri, Mariam; Remer, Erick M; Gould, Elaine S; Smith, Stacy

    2016-08-17

    Although some research and publication practices are clearly unethical, including fraud and plagiarism, other areas of research and publication, such as informed consent and conflicts of interest, fall into grayer areas. The purposes of this article are, therefore, to review a variety of relevant ethical issues in radiology-related journalism, peer review, and research; to review the radiology literature to date that has addressed these issues; and to present position statements and potential solutions to these problems.

  6. Effect of grade point average and enrollment in a dental hygiene National Board review course on student performance on the National Board Examination.

    Science.gov (United States)

    DeWald, Janice P; Gutmann, Marylou E; Solomon, Eric S

    2004-01-01

    Passing the National Board Dental Hygiene Examination is a requirement for licensure in all but one state. There are a number of preparation courses for the examination sponsored by corporations and dental hygiene programs. The purpose of this study was to determine if taking a board review course significantly affected student performance on the board examination. Students from the last six dental hygiene classes at Baylor College of Dentistry (n = 168) were divided into two groups depending on whether they took a particular review course. Mean entering college grade point averages (GPA), exiting dental hygiene program GPAs, and National Board scores were compared for the two groups using a t-test for independent samples (p < 0.05). No significant differences were found between the two groups for entering GPA and National Board scores. Exiting GPAs, however, were slightly higher for those not taking the course compared to those taking the course. In addition, a strong correlation (0.71, Pearson Correlation) was found between exiting GPA and National Board score. Exiting GPA was found to be a strong predictor of National Board performance. These results do not appear to support this program's participation in an external preparation course as a means of increasing students' performance on the National Board Dental Hygiene Examination.

  7. Ethics approval: responsibilities of journal editors, authors and research ethics committees.

    Science.gov (United States)

    Bain, Luchuo Engelbert

    2017-01-01

    Meaningful progress of medicine depends on research that must ultimately involve human subjects. Obtaining ethical approval therefore, especially in medical sciences, should be a moral reflex for researchers. This unfortunately is not the case, with numerous researchers bypassing the ethics approval procedure, or simply unaware of its importance. Good research involves risks taken by research participants and uses tax payers' money in the process. These mandates the research endeavor to aim at attaining the highest degree of respect for the sacrifices made by others for science. Most researchers mistake scientific clearance or approval, for ethics approval. For a study to be ethical sound, it must be scientifically sound. This is only one of the activities carried out during protocol review. It is not uncommon for sensitive ethical concerns, especially in the social sciences to be overlooked and considered not to be accompanied by any serious risks for the research participants.The researcher has the responsibility of systematically consulting the competent ethics committee for advice and consequent approvals or ethical waivers. Journal editors and reviewers have the duty to systematically evaluate the ethical soundness of manuscripts submitted for review. Capacity building in research ethics and institutional support for Research Ethics Committees to speed up protocol review could reduce the incentive of carrying out research in human subjects without ethics approvals. It is hypocritical and idle to continue to expect optimal reviews on time and of good quality, from ethics committees functioning purely on altruistic grounds. Capacity building for researchers in research ethics, and institutional reforms and support for Research Ethics Committees appear not to have received the attention they truly deserve.

  8. Ethical considerations in sexual health research: A narrative review

    Directory of Open Access Journals (Sweden)

    Maryam Shirmohammadi

    2018-01-01

    Full Text Available Background: There is an assumption that sexual health research has great influence on the quality of human life through elevating sexual health standards, and their results will eliminate the burden of sexual health challenges on family relationships. The aim of this study was to review ethical considerations in sexual health research. Materials and Methods: This narrative review was conducted between January 1990 and December 2017 based on the five-step approach of York University. The keywords used to search for the studies included ethical issues, research, sexual health, reproductive health, and sensitive topics. The language of the literatures was English and the search process was performed on PubMed, Elsevier, Ovid, Springer, Google Scholar, ResearchGate, SAGE Publishing, ProQuest, WHO website, Kinsey Confidential, and Worldsexology. Results: After assessing the quality and eligibility of 94 articles, 13 were selected. The results of the present study showed that the most important ethical considerations were protecting the confidentiality and privacy of participants, obtaining informed consent, and paying attention to vulnerable people. Conclusions: The review of literature exhibited several considerations that sexual health researchers are faced with. In order to manage these considerations, the researcher should have sufficient understanding of them. The important matter is that strategies to manage these challenges should be completely rational and practical according to each context. These strategies can also be applied in other societies with great similarities in their context.

  9. Rewind, review, reflect and fast forward: from Ethics to GeoEthics.

    Science.gov (United States)

    Marone, Eduardo

    2017-04-01

    Philosophy has as many definitions as philosophers but, at the end of the day, it is no more and no less than the science of thinking using the reason. It gives us tools for rationalizing, following logical paths and with a critical eye, to understand the material and immaterial substance of the universe. It has many branches, and a couple of them, Ethics and Epistemology, are central for the evolution of the human knowledge, among many others. Today, at the XXI Century, it seems that the lack of formal and adequate education on such important matters is making the act of "thinking" not so important when compared with the accumulation of "information", right or wrong, pasteurized or in disconnected pieces, with no much room/time for critical and logical analysis (Philosophy). If the tools to build the knowledge (Epistemology) are not usually familiar to the scientists and, worst, the need of taking the right actions with the generated new and existing knowledge (Ethics) is not a priority; the outputs cannot be the best ones. There have been several academic works and meetings looking into the causes of the scholarly illiteracy on Ethics and Epistemology in Earth Sciences. Among them, our sessions at EGU have endured showing important aspects that need to be tackled and, particularly, insisting in the fact that it is a continuous effort. However, we still need to go back (Rewind) to the main principles of Philosophy, Epistemology and Ethics, looking at them with care (Review), and think (Reflecting) returning to the present (Fast Forward) to make the world better for future generations. Geoethics consists of research and reflection on the values that underpin appropriate behaviours and practices, wherever human activities interact with the Earth system. Although more general ethical issues, which affect other/all sciences practices and behaviours, are included among the Geoethic concerns (as plagiarism, harassment, gender equity, etc.), the focus remains at the

  10. 78 FR 58383 - Senior Executive Service; Combined Performance Review Board (PRB)

    Science.gov (United States)

    2013-09-23

    ... DEPARTMENT OF THE TREASURY United States Mint Senior Executive Service; Combined Performance Review Board (PRB) AGENCY: United States Mint (USM), Treasury. ACTION: Notice of members of Combined... Trade Bureau (TTB). The Combined PRB reviews the performance appraisals of career senior executives...

  11. 76 FR 69770 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2011-11-09

    ... OFFICE OF PERSONNEL MANAGEMENT Senior Executive Service Performance Review Board AGENCY: Office of... of a senior executive's performance by the supervisor, and considers recommendations to the appointing authority regarding the performance of the senior executive. Office of Personnel Management. John...

  12. 78 FR 44577 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2013-07-24

    ... DEPARTMENT OF HOMELAND SECURITY Office of the Secretary Senior Executive Service Performance... notice announces the appointment of the members of the Senior Executive Service Performance Review Boards... other appropriate personnel actions for incumbents of Senior Executive Service, Senior Level and Senior...

  13. Nursing and euthanasia: a review of argument-based ethics literature.

    Science.gov (United States)

    Quaghebeur, Toon; Dierckx de Casterlé, Bernadette; Gastmans, Chris

    2009-07-01

    This article gives an overview of the nursing ethics arguments on euthanasia in general, and on nurses' involvement in euthanasia in particular, through an argument-based literature review. An in-depth study of these arguments in this literature will enable nurses to engage in the euthanasia debate. We critically appraised 41 publications published between January 1987 and June 2007. Nursing ethics arguments on (nurses' involvement in) euthanasia are guided primarily by the principles of respect for autonomy, nonmaleficence, beneficence and justice. Ethical arguments related to the nursing profession are described. From a care perspective, we discuss arguments that evaluate to what degree euthanasia can be considered positively or negatively as a form of good nursing care. Most arguments in the principle-, profession- and care-orientated approaches to nursing ethics are used both pro and contra euthanasia in general, and nurses' involvement in euthanasia in particular.

  14. Social and ethical aspects of forensic genetics: A critical review.

    Science.gov (United States)

    Williams, R; Wienroth, M

    2017-07-01

    This review describes the social and ethical responses to the history of innovations in forensic genetics and their application to criminal investigations. Following an outline of the three recurrent social perspectives that have informed these responses (crime management, due process, and genetic surveillance), it goes on to introduce the repertoire of ethical considerations by describing a series of key reports that have shaped subsequent commentaries on forensic DNA profiling and databasing. Four major ethical concerns form the focus of the remainder of the paper (dignity, privacy, justice, and social solidarity), and key features of forensic genetic practice are examined in the light of these concerns. The paper concludes with a discussion of the concept of "proportionality" as a resource for balancing the social and ethical risks and benefits of the use of forensic genetics in support of criminal justice. Copyright © 2017 Central Police University.

  15. National scientific literature on nursing ethics: a systematic Review

    Directory of Open Access Journals (Sweden)

    Ilka Nicéia D’Aquino Oliveira Teixeira

    2010-03-01

    Full Text Available Objective: To identify the most prevalent nursing ethical issues published in scientific Brazilian journals. Methods: A systematic literature review with the following inclusion criteria: (1 articles on Nursing Ethics written in Portuguese, English, French, and Spanish; (2 published in Brazilian journals; (3 in the period from January 1997 to February 2009. The search was carried out in four databases BDENF, LILACS, MEDLINE, and SCIELO. The key-words were ethics AND nursing. The selected studies were classified into categories. The content of the articles were analyzed using the Collective Subject Discourse. The categories generated discourses by organizing the main excerpts from the abstracts of the selected studies, which are the “key expressions”. Results: A hundred and thirty three articles that met the inclusion criteria were classified into eight categories: 1. Nursing Care; 2. Dilemmas and Controversies; 3. Education; 4. Legal Aspects; 5. Research; 6. Management; 7. Values and Beliefs; 8. Perspectives and Health Policies. The category “Nursing Care” prevailed in 36% of the selected articles, and it was classified into six subcategories. “Dilemmas and Controversies” was the second most prevalent category (15%. Conclusion: The number of theoretical papers on ethical issues is high, but there is little research on the ethical experiences in nursing practice.

  16. [Is there room for improvement in the field of dental ethics?].

    Science.gov (United States)

    Billaud, Adelin; Pirnay, Philippe

    2015-01-01

    Dental ethics, enforced by the Dental Board, are defined in the Code of Conduct for dentists included in the French Public Health Code. Dentist-patient relationships are changing, while scientific progress advances more rapidly than dental ethics. Are dental ethics still adapted to the practice of dentistry? This study was based on the Institut BVA “The French and patients’ rights” survey conducted in September 2013, together with a systematic review of the literature using the Medline, Legifrance, Lexisnexis, and Elnet.fr databases and the Paris Descartes University medical library website. Five essential principles were identified and a total of 210 articles were included. The results indicate that there is room for improvement in pain management, respect of human dignity, information and consent concerning healthcare, and free choice of a practitioner. Dental ethics have evolved, but further improvement is required to adapt the dentist-patient relationship to scientific progress and the patients’ expectations. To ensure a truly informed choice, this article shows that dental ethics cannot vary in response to surveys or fashions, as dental practice must remain essentially based on an ethical approach that cannot be rigidly defined in a code of professional conduct.

  17. Ethics policy review: a case study in quality improvement.

    Science.gov (United States)

    Frolic, Andrea Nadine; Drolet, Katherine

    2013-02-01

    Policy work is often cited as one of the primary functions of Hospital Ethics Committees (HECs), along with consultation and education. Hospital policies can have far reaching effects on a wide array of stakeholders including, care providers, patients, families, the culture of the organisation and the community at large. In comparison with the wealth of information available about the emerging practice of ethics consultation, relatively little attention has been paid to the policy work of HECs. In this paper, we hope to advance the development of best practices in HEC policy work by describing the quality improvement process that we undertook at Hamilton Health Sciences, Hamilton, Ontario, Canada. In the first section of the paper we describe the context of our HEC policy work, and the shortcomings of our historical review process. In subsequent sections, we detail the quality improvement project we undertook in 2010, the results of the project and the specific tools we developed to enhance the quality of HEC policy work. Our goal in sharing this organisational case study is to prompt other HECs to publish qualitative descriptions of their policy work, in order to generate a body of knowledge that can inform the development of best practices for ethics policy review.

  18. Pharmaceuticalisation and ethical review in South Asia: issues of scope and authority for practitioners and policy makers.

    Science.gov (United States)

    Simpson, Bob; Khatri, Rekha; Ravindran, Deapica; Udalagama, Tharindi

    2015-04-01

    Ethical review by expert committee continues to be the first line of defence when it comes to protecting human subjects recruited into clinical trials. Drawing on a large scale study of biomedical experimentation across South Asia, and specifically on interviews with 24 ethical review committee [ERC] members across India, Sri Lanka and Nepal, this article identifies some of the tensions that emerge for ERC members as the capacity to conduct credible ethical review of clinical trials is developed across the region. The article draws attention to fundamental issues of scope and authority in the operation of ethical review. On the one hand, ERC members experience a powerful pull towards harmonisation and a strong alignment with international standards deemed necessary for the global pharmaceutical assemblage to consolidate and extend. On the other hand, they must deal with what is in effect the double jeopardy of ethical review in developing world contexts. ERC members must undertake review but are frequently made aware of their responsibility to protect interests that go beyond the 'human subject' and into the realms of development and national interest [for example, in relation to literacy and informed consent]. These dilemmas are indicative of broader questions about where ethical review sits in institutional terms and how it might develop to best ensure improved human subject protection given growth of industry-led research. Crown Copyright © 2014. Published by Elsevier Ltd. All rights reserved.

  19. 76 FR 61346 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2011-10-04

    ... DEPARTMENT OF DEFENSE Office of the Secretary Senior Executive Service Performance Review Board AGENCY: Department of Defense Office of Inspector General, Department of Defense (DoD). ACTION: Notice. SUMMARY: This notice announces the appointment of the members of the Senior Executive Service (SES...

  20. 77 FR 60450 - Senior Executive Service Performance Review Board

    Science.gov (United States)

    2012-10-03

    ... DEPARTMENT OF HOMELAND SECURITY Office of the Secretary Senior Executive Service Performance... announces the appointment of the members of the Senior Executive Service Performance Review Boards for the... appropriate personnel actions for incumbents of Senior Executive Service, Senior Level and Senior Professional...

  1. Coverage: An Ethical Dilemma.

    Science.gov (United States)

    Feldman, Brenda J.

    1994-01-01

    Discusses how a high school journalism advisor dealt with ethical issues (including source attribution) surrounding the publication of a story about violation of school board policies by representatives of a nationally recognized ring company. (RS)

  2. Ethical Design of Intelligent Assistive Technologies for Dementia: A Descriptive Review.

    Science.gov (United States)

    Ienca, Marcello; Wangmo, Tenzin; Jotterand, Fabrice; Kressig, Reto W; Elger, Bernice

    2017-09-22

    The use of Intelligent Assistive Technology (IAT) in dementia care opens the prospects of reducing the global burden of dementia and enabling novel opportunities to improve the lives of dementia patients. However, with current adoption rates being reportedly low, the potential of IATs might remain under-expressed as long as the reasons for suboptimal adoption remain unaddressed. Among these, ethical and social considerations are critical. This article reviews the spectrum of IATs for dementia and investigates the prevalence of ethical considerations in the design of current IATs. Our screening shows that a significant portion of current IATs is designed in the absence of explicit ethical considerations. These results suggest that the lack of ethical consideration might be a codeterminant of current structural limitations in the translation of IATs from designing labs to bedside. Based on these data, we call for a coordinated effort to proactively incorporate ethical considerations early in the design and development of new products.

  3. Ethics, equality and evidence in health promotion

    DEFF Research Database (Denmark)

    Vallgårda, Signild

    2014-01-01

    Abstract Aim: The Danish National Board of Health has expressed its commitment to social equality in health, evidence-informed health promotion and public health ethics, and has issued guidelines for municipalities on health promotion, in Danish named prevention packages.The aim of this article...... is to analyse whether the Board of Health adheres to ideals of equality, evidence and ethics in these guidelines. Methods: An analysis to detect statements about equity, evidence and ethics in 10 health promotion packages directed at municipalities with the aim of guiding the municipalities towards evidence......-informed disease prevention and health promotion. Results: Despite declared intentions of prioritizing social equality in health, these intentions are largely absent from most of the packages.When health inequalities are mentioned, focus is on the disadvantaged or the marginalized. Several interventions...

  4. An algorithm for evaluating the ethics of a placebo-controlled trial.

    Science.gov (United States)

    Amdur, R J; Biddle, C J

    2001-10-20

    The purpose of this article is to clarify the decision points that are important to consider when evaluating the ethics of a placebo-controlled trial. The ethical requirements for research involving human subjects are reviewed, and the rationale for and potential problems with concomitant placebo control are explained. A series of case discussions are used to illustrate each decision point. The critical decision points in the evaluation of the ethics of a placebo-controlled trial are as follows: (i) Is placebo being used in place of standard therapy? (ii) Is standard therapy likely to be effective? (iii) Is the toxicity of standard therapy such that patients routinely refuse this treatment? (iv) Could the use of placebo result in severe suffering or irreversible harm? (v) Is the variability in the placebo response such that it is reasonable to consider other options for the control group? (vi) Would a reasonable person with an average degree of altruism and risk aversiveness agree to participate in this study? The algorithm presented in this article gives researchers and research monitors (such as Institutional Review Board members) the tools they need to evaluate the ethics of a study that uses concomitant placebo control. Copyright 2001 Wiley-Liss, Inc.

  5. Activities of an ethics consultation service in a Tertiary Military Medical Center.

    Science.gov (United States)

    Waisel, D B; Vanscoy, S E; Tice, L H; Bulger, K L; Schmelz, J O; Perucca, P J

    2000-07-01

    The Joint Commission on Accreditation of Healthcare Organizations requires hospitals to have a mechanism to address issues of medical ethics. Most hospitals, especially those in the military, have an ethics committee composed solely of members who serve as an additional duty. To enhance the ethics consultation service, the 59th Medical Wing created a position under the chief of the medical staff for a full-time, fellowship-trained, medical ethicist. After establishment of this position, the number of consultations increased, a systematic program for caregiver education was developed and delivered, and an organizational presence was achieved by instituting positions on the institutional review board, the executive committee of the medical staff, and the credentials committee. Issues in medical care are becoming increasingly complicated, due in large part to financial stresses and technological advancements. Ethics consultation can help prevent and resolve many of these problems. This report discusses the activities of the first year of a full-time ethicist in a tertiary military medical center.

  6. Preparing students for the ethical challenges on international health electives: A systematic review of the literature on educational interventions.

    Science.gov (United States)

    Rahim, Anika; Knights Née Jones, Felicity; Fyfe, Molly; Alagarajah, Janagan; Baraitser, Paula

    2016-09-01

    International health electives pose specific ethical challenges for students travelling from to low and middle income countries. We undertook a systematic review of the literature on interventions to prepare students to identify ethical issues addressed, educational approaches and to collate evidence on the effectiveness of different strategies. We searched nine electronic databases of peer-reviewed literature and identified grey literature through key word searches; supplemented through citation mapping and expert consultation. Articles that described ethical training conducted by universities or professional bodies were included for review. We reviewed forty-four full text articles. Ten sources of published literature and seven sources of grey literature met our inclusion criteria. We identified thirteen ethical situations that students should be prepared to manage and eight generic skills to support this process. Most interventions were delivered before the elective, used case studies or guidelines. Some suggested ethical principles or a framework for analysis of ethical issues. Only two papers evaluated the intervention described. Our paper collates a small but growing body of work on education to prepare students to manage ethical issues. Ethical training should have elements that are delivered before, during and after the elective. Interventions should include case studies covering thirteen ethical issues identified here, linked to ethical principles and a process for responding to ethical issues. We suggest that evaluations of interventions are an important area for future research.

  7. Forensic psychiatry, one subspecialty with two ethics? A systematic review.

    Science.gov (United States)

    Niveau, Gérard; Welle, Ida

    2018-04-10

    Forensic psychiatry is a particular subspecialty within psychiatry, dedicated in applying psychiatric knowledge and psychiatric training for particular legal purposes. Given that within the scope of forensic psychiatry, a third party usually intervenes in the patient-doctor relationship, an amendment of the traditional ethical principles seems justified. Thus, 47 articles, two book chapters and the guidelines produced by the World Psychiatric Association, the American Association of Psychiatry and the Law, as well as by the Royal Australian and New Zealand College of psychiatrists, were analyzed. The review revealed that the ethics of correctional forensic psychiatry and those of legal forensic psychiatry do not markedly differ from each other, but they are incongruent in terms of implementation. In an effort to better understand which ethical principles apply to forensic psychiatry, a chronological review of the literature published from 1950 to 2015 was carried out. The ethics of correctional forensic psychiatry are primarily deontological. The principle of justice translates into the principle of health care equivalence, the principle of beneficence into providing the best possible care to patients, and the principle of respect of autonomy into ensuring confidentiality and informed consent. The ethics of legal forensic psychiatry are rather consequentialist. In this latter setting, the principle of justice is mainly characterized by professionalism, the principle of beneficence by objectivity and impartiality, and the principle of respect of autonomy by informed consent. However, these two distinct fields of forensic psychiatry share in common the principle of non maleficence, defined as the non collaboration of the psychiatrist in any activity leading to inhuman and degrading treatment or to the death penalty.

  8. 12 CFR 1710.14 - Code of conduct and ethics.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 7 2010-01-01 2010-01-01 false Code of conduct and ethics. 1710.14 Section... Code of conduct and ethics. (a) General. An Enterprise shall establish and administer a written code of conduct and ethics that is reasonably designed to assure the ability of board members, executive officers...

  9. 75 FR 67696 - Membership of the Performance Review Board

    Science.gov (United States)

    2010-11-03

    ...: Defense Finance and Accounting Service, DoD. ACTION: Notice. SUMMARY: This notice announces the appointment of the members of the Performance Review Board (PRB) of the Defense Finance and Accounting Service.... FOR FURTHER INFORMATION CONTACT: Denise Thornburg, DFAS SES Program Manager, Defense Finance and...

  10. “Just Chatting”: Research Ethics and Cyberspace

    Directory of Open Access Journals (Sweden)

    Ellen Whiteman

    2007-06-01

    Full Text Available Research conducted through computer-mediated communication is challenging traditional definitions of what is ethical research. In this article the author examines the changing role of assent/consent, confidentiality, and participant observation in qualitative research conducted in cyberspace. She concludes that REBs (research ethic boards might be becoming more conservative in their decisions at the very moment that Internet research requires more flexibility and broader ethical definitions.

  11. 78 FR 50144 - Rehabilitation Research and Development Service Scientific Merit Review Board; Notice of Meetings

    Science.gov (United States)

    2013-08-16

    ... Review Board; Notice of Meetings The Department of Veterans Affairs (VA) gives notice under the Federal... Development Service Scientific Merit Review Board will meet from 8 a.m. to 5 p.m. on the dates indicated below: Subcommittee Date(s) Location Career Development Award Program.... August 6, 2013........ VHA National...

  12. An author's guide to publication ethics: a review of emerging standards in biomedical journals.

    Science.gov (United States)

    Roberts, Jason

    2009-04-01

    Universal definitions of ethical issues related to medical publishing have remained somewhat elusive. Training in the art of writing for medical journals is inconsistent and most commonly informal, involving collaborative efforts between mentors and students. This approach inadvertently may perpetuate erroneous assumptions as to what constitutes acceptable behavior. In contrast to instruction on composition, ethical considerations related to the publication of a paper are likely to receive little attention. Even so, consequent to the ever-increasing scrutiny from the media and government agencies, journals are recognizing the need for greater transparency in peer review and are thus more inclined to enforce ethical standards. Understanding that some apparent ethical contraventions are the result of confusion or a lack of knowledge, some journals are assuming the responsibility of educating their community about ethical issues in publishing. This paper reviews the key ethical issues (eg, authorship criteria, conflicts of interest, redundant publication, data access and biases in data reporting, image manipulation) that authors should consider before submitting a manuscript. It also surveys some of the policies of the most highly cited clinical medical journals. In the future, authors can anticipate that their submissions will be required to meet an expanding array of ethical standards.

  13. 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...

  14. A scoping review of reporting 'Ethical Research Practices' in research conducted among refugees and war-affected populations in the Arab world.

    Science.gov (United States)

    Makhoul, Jihad; Chehab, Rana F; Shaito, Zahraa; Sibai, Abla M

    2018-05-15

    Ethical research conduct is a cornerstone of research practice particularly when research participants include vulnerable populations. This study mapped the extent of reporting ethical research practices in studies conducted among refugees and war-affected populations in the Arab World, and assessed variations by time, country of study, and study characteristics. An electronic search of eight databases resulted in 5668 unique records published between 2000 and 2013. Scoping review yielded 164 eligible articles for analyses. Ethical research practices, including obtaining institutional approval, access to the community/research site, and informed consent/assent from the research participants, were reported in 48.2, 54.9, and 53.7% of the publications, respectively. Institutional approval was significantly more likely to be reported when the research was biomedical in nature compared to public health and social (91.7% vs. 54.4 and 32.4%), when the study employed quantitative compared to qualitative or mixed methodologies (61.7% vs. 26.8 and 42.9%), and when the journal required a statement on ethical declarations (57.4% vs. 27.1%). Institutional approval was least likely to be reported in papers that were sole-authored (9.5%), when these did not mention a funding source (29.6%), or when published in national journals (0%). Similar results were obtained for access to the community site and for seeking informed consent/assent from study participants. The responsibility of inadequacies in adherence to ethical research conduct in crisis settings is born by a multitude of stakeholders including funding agencies, institutional research boards, researchers and international relief organizations involved in research, as well as journal editors, all of whom need to play a more proactive role for enhancing the practice of ethical research conduct in conflict settings.

  15. Readiness of ethics review systems for a changing public health landscape in the WHO African Region.

    Science.gov (United States)

    Motari, Marion; Ota, Martin Okechukwu; Kirigia, Joses Muthuri

    2015-12-02

    The increasing emphasis on research, development and innovation for health in providing solutions to the high burden of diseases in the African Region has warranted a proliferation of studies including clinical trials. This changing public health landscape requires that countries develop adequate ethics review capacities to protect and minimize risks to study participants. Therefore, this study assessed the readiness of national ethics committees to respond to challenges posed by a globalized biomedical research system which is constantly challenged by new public health threats, rapid scientific and technological advancements affecting biomedical research and development, delivery and manufacture of vaccines and therapies, and health technology transfer. This is a descriptive study, which used a questionnaire structured to elicit information on the existence of relevant national legal frameworks, mechanisms for ethical review; as well as capacity requirements for national ethics committees. The questionnaire was available in English and French and was sent to 41 of the then 46 Member States of the WHO African Region, excluding the five Lusophone Member States. Information was gathered from senior officials in ministries of health, who by virtue of their offices were considered to have expert knowledge of research ethics review systems in their respective countries. Thirty three of the 41 countries (80.5 %) responded. Thirty (90.9 %) of respondent countries had a national ethics review committee (NEC); 79 % of which were established by law. Twenty-five (83.3 %) NECs had secretarial and administrative support. Over 50 % of countries with NECs indicated a need for capacity strengthening through periodic training on international guidelines for health research (including clinical trials) ethics; and allocation of funds for administrative and secretariat support. Despite the existing training initiatives, the Region still experiences a shortage of professionals

  16. Ethics Management: How to Achieve Ethical Organizations and Management?

    Directory of Open Access Journals (Sweden)

    Carita Lilian Snellman

    2015-12-01

    Full Text Available The last decades’ serious organizational scandals that mainly stem from corruption and conflicting interests but also from bribery, favoritism and other wrongdoings have ac-centuated the need for finding instruments for achieving more ethical organizations and management. Ethics management is particularly important in the public sector because public employees and holders of public office are responsible for increasing wellbeing and providing common good for all citizens. Only accountable management striving for integrity through ethical practices and decision making will guarantee ethical organiza-tional behavior. In spite of increasing research on ethics in general and ethics manage-ment in particular, increase in organizational scandals indicates that there is knowledge gap concerning ethical instruments that help to solve ethical problems. The aim of this paper is to shed light on ethical theories and instruments, and wrongdoings in public sec-tor organizations. The main questions are; why is there so much wrongdoing; how can it be reduced; and how can more ethical organization and management be achieved. This is a review paper aiming to provide a review of ethical theories and instruments and dis-cuss serious wrongdoings and the role of ethics in the public sector. The paper contrib-utes to the fields of management and organization, ethics, and public management.

  17. 75 FR 68385 - Senior Executive Service-Performance Review Board

    Science.gov (United States)

    2010-11-05

    ... OPM Performance Review Board. FOR FURTHER INFORMATION CONTACT: Tammy Van Keuren, OPM Human Resources, Recruitment and Staffing, Office of Personnel Management, 1900 E Street NW., Washington, DC 20415, (202) 606... Associate Director for Human Resources--Executive Secretariat. [FR Doc. 2010-28171 Filed 11-4-10; 8:45 am...

  18. Teaching Medical Ethics in Graduate and Undergraduate Medical Education: A Systematic Review of Effectiveness.

    Science.gov (United States)

    de la Garza, Santiago; Phuoc, Vania; Throneberry, Steven; Blumenthal-Barby, Jennifer; McCullough, Laurence; Coverdale, John

    2017-08-01

    One objective was to identify and review studies on teaching medical ethics to psychiatry residents. In order to gain insights from other disciplines that have published research in this area, a second objective was to identify and review studies on teaching medical ethics to residents across all other specialties of training and on teaching medical students. PubMed, EMBASE, and PsycINFO were searched for controlled trials on teaching medical ethics with quantitative outcomes. Search terms included ethics, bioethics, medical ethics, medical students, residents/registrars, teaching, education, outcomes, and controlled trials. Nine studies were found that met inclusion criteria, including five randomized controlled trails and four controlled non-randomized trials. Subjects included medical students (5 studies), surgical residents (2 studies), internal medicine house officers (1 study), and family medicine preceptors and their medical students (1 study). Teaching methods, course content, and outcome measures varied considerably across studies. Common methodological issues included a lack of concealment of allocation, a lack of blinding, and generally low numbers of subjects as learners. One randomized controlled trial which taught surgical residents using a standardized patient was judged to be especially methodologically rigorous. None of the trials incorporated psychiatry residents. Ethics educators should undertake additional rigorously controlled trials in order to secure a strong evidence base for the design of medical ethics curricula. Psychiatry ethics educators can also benefit from the findings of trials in other disciplines and in undergraduate medical education.

  19. Professional Ethics Education for Future Teachers: A Narrative Review of the Scholarly Writings

    Science.gov (United States)

    Maxwell, Bruce; Schwimmer, Marina

    2016-01-01

    This article provides a narrative review of the scholarly writings on professional ethics education for future teachers. Against the background of a widespread belief among scholars working in this area that longstanding and sustained research and reflection on the ethics of teaching have had little impact on the teacher education curriculum, the…

  20. Enabling Ethical Code Embeddedness in Construction Organizations: A Review of Process Assessment Approach.

    Science.gov (United States)

    Oladinrin, Olugbenga Timo; Ho, Christabel Man-Fong

    2016-08-01

    Several researchers have identified codes of ethics (CoEs) as tools that stimulate positive ethical behavior by shaping the organisational decision-making process, but few have considered the information needed for code implementation. Beyond being a legal and moral responsibility, ethical behavior needs to become an organisational priority, which requires an alignment process that integrates employee behavior with the organisation's ethical standards. This paper discusses processes for the responsible implementation of CoEs based on an extensive review of the literature. The internationally recognized European Foundation for Quality Management Excellence Model (EFQM model) is proposed as a suitable framework for assessing an organisation's ethical performance, including CoE embeddedness. The findings presented herein have both practical and research implications. They will encourage construction practitioners to shift their attention from ethical policies to possible enablers of CoE implementation and serve as a foundation for further research on ethical performance evaluation using the EFQM model. This is the first paper to discuss the model's use in the context of ethics in construction practice.

  1. 78 FR 28243 - Senior Executive Service; Performance Review Board; Members

    Science.gov (United States)

    2013-05-14

    ... NATIONAL CAPITAL PLANNING COMMISSION Senior Executive Service; Performance Review Board; Members AGENCY: National Capital Planning Commission. ACTION: Notice of Members of Senior Executive Service... Senior Executive Service. The PRB established for the National Capital Planning Commission also makes...

  2. 76 FR 29013 - Senior Executive Service; Performance Review Board; Members

    Science.gov (United States)

    2011-05-19

    ... NATIONAL CAPITAL PLANNING COMMISSION Senior Executive Service; Performance Review Board; Members AGENCY: National Capital Planning Commission. ACTION: Notice of Members of Senior Executive Service... Senior Executive Service. The PRB established for the National Capital Planning Commission also makes...

  3. Ethical sensitivity, burnout, and job satisfaction in emergency nurses.

    Science.gov (United States)

    Palazoğlu, Cansu Atmaca; Koç, Zeliha

    2017-01-01

    Rising levels of burnout and decreasing job satisfaction can inhibit healthcare professionals from providing high-quality care due to a corresponding decrease in their ethical sensitivity. This study aimed to determine the relationship between the level of ethical sensitivity in emergency service nurses and their levels of burnout and job satisfaction. This research employed a descriptive and cross-sectional design. Participants and research context: This study was conducted with a sample of 236 nurses, all of whom worked in emergency service between 24 July 2015 and 28 April 2016. Data were collected using the Moral Sensitivity Questionnaire, Maslach Burnout Inventory, and Minnesota Job Satisfaction Scale. Ethical considerations: This study was approved by the Institutional Ethics Review Board of Ondokuz Mayıs University. There was a weak and negative correlation (r = -0.158, p = 0.015) between Moral Sensitivity Questionnaire and Maslach Burnout Inventory scores. There was also a weak and negative correlation (r = -0.335, p Burnout Inventory and Minnesota Job Satisfaction Scale scores. Decreased job satisfaction and increased burnout levels among emergency service nurses might result in them indulging in improper practices, frequently facing ethical problems, and a decrease in the overall quality of service in hospitals. In order for emergency service nurses to recognize ethical problems and make the most accurate decisions, a high level of ethical sensitivity is critical. In this respect, it is suggested that continuing education after graduation and training programs should be organized.

  4. Can Neuroscience Contribute to Practical Ethics? A Critical Review and Discussion of the Methodological and Translational Challenges of the Neuroscience of Ethics.

    Science.gov (United States)

    Racine, Eric; Dubljević, Veljko; Jox, Ralf J; Baertschi, Bernard; Christensen, Julia F; Farisco, Michele; Jotterand, Fabrice; Kahane, Guy; Müller, Sabine

    2017-06-01

    Neuroethics is an interdisciplinary field that arose in response to novel ethical challenges posed by advances in neuroscience. Historically, neuroethics has provided an opportunity to synergize different disciplines, notably proposing a two-way dialogue between an 'ethics of neuroscience' and a 'neuroscience of ethics'. However, questions surface as to whether a 'neuroscience of ethics' is a useful and unified branch of research and whether it can actually inform or lead to theoretical insights and transferable practical knowledge to help resolve ethical questions. In this article, we examine why the neuroscience of ethics is a promising area of research and summarize what we have learned so far regarding its most promising goals and contributions. We then review some of the key methodological challenges which may have hindered the use of results generated thus far by the neuroscience of ethics. Strategies are suggested to address these challenges and improve the quality of research and increase neuroscience's usefulness for applied ethics and society at large. Finally, we reflect on potential outcomes of a neuroscience of ethics and discuss the different strategies that could be used to support knowledge transfer to help different stakeholders integrate knowledge from the neuroscience of ethics. © 2017 John Wiley & Sons Ltd.

  5. Teaching medical students to discern ethical problems in human clinical research studies.

    Science.gov (United States)

    Roberts, Laura Weiss; Warner, Teddy D; Green Hammond, Katherine A; Brody, Janet L; Kaminsky, Alexis; Roberts, Brian B

    2005-10-01

    Investigators and institutional review boards are entrusted with ensuring the conduct of ethically sound human studies. Assessing ethical aspects of research protocols is a key skill in fulfilling this duty, yet no empirically validated method exists for preparing professionals to attain this skill. The authors performed a randomized controlled educational intervention, comparing a criteria-based learning method, a clinical-research- and experience-based learning method, and a control group. All 300 medical students enrolled at the University of New Mexico School of Medicine in 2001 were invited to participate. After a single half-hour educational session, a written posttest of ability to detect ethical problems in hypothetical protocol vignettes was administered. The authors analyzed responses to ten protocol vignettes that had been evaluated independently by experts. For each vignette, a global assessment of the perceived significance of ethical problems and the identification of specific ethical problems were evaluated. Eighty-three medical students (27%) volunteered: 50 (60%) were women and 55 (66%) were first- and second-year students. On global assessments, the criteria-focused group perceived ethical problems as more significant than did the other two groups (p evaluation skills. This work supports the potential value of empirically derived methods for preparing professionals to discern ethical aspects of human studies.

  6. Palliative Sedation for Existential Suffering: A Systematic Review of Argument-Based Ethics Literature.

    Science.gov (United States)

    Rodrigues, Paulo; Crokaert, Jasper; Gastmans, Chris

    2018-06-01

    Although unanimity exists on using palliative sedation (PS) for controlling refractory physical suffering in end-of-life situations, using it for controlling refractory existential suffering (PS-ES) is controversial. Complicating the debate is that definitions and terminology for existential suffering are unclear, ambiguous, and imprecise, leading to a lack of consensus for clinical practice. To systematically identify, describe, analyze, and discuss ethical arguments and concepts underpinning the argument-based bioethics literature on PS-ES. We conducted a systematic search of the argument-based bioethics literature in PubMed, CINAHL, Embase ® , The Philosopher's Index, PsycINFO ® , PsycARTICLES ® , Scopus, ScienceDirect, Web of Science, Pascal-Francis, and Cairn. We included articles published in peer-reviewed journals till December 31, 2016, written in English or French, which focused on ethical arguments related to PS-ES. We used Peer Review of Electronic Search Strategies protocol, Preferred Reporting Items for Systematic Reviews and Meta-Analyses, and The Qualitative Analysis Guide of Leuven for data extraction and synthesis of themes. We identified 18 articles that met the inclusion criteria. Our analysis revealed mind-body dualism, existential suffering, refractoriness, terminal condition, and imminent death as relevant concepts in the ethical debate on PS-ES. The ethical principles of double effect, proportionality, and the four principles of biomedical ethics were used in argumentations in the PS-ES debate. There is a clear need to better define the terminology used in discussions of PS-ES and to ground ethical arguments in a more effective way. Anthropological presuppositions such as mind-body dualism underpin the debate and need to be more clearly elucidated using an interdisciplinary approach. Copyright © 2018 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  7. Ethical Challenges of Medicine and Health on the Internet: A Review

    Science.gov (United States)

    2001-01-01

    Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role

  8. Ethical challenges of medicine and health on the Internet: a review.

    Science.gov (United States)

    Dyer, K A

    2001-01-01

    Knowledge and capabilities, particularly of a new technology or in a new area of study, frequently develop faster than the guidelines and principles needed for practitioners to practice ethically in the new arena; this is particularly true in medicine. The blending of medicine and healthcare with e-commerce and the Internet raises many questions involving what sort of ethical conduct should be expected by practitioners and developers of the medical Internet. Some of the early pioneers in medical and healthcare Web sites pushed the ethical boundaries with questionable, even unethical, practices. Many involved with the medical Internet are now working to reestablish patient and consumer trust by establishing guidelines to determine how the fundamentals of the medical code of ethical conduct can best be adapted for the medical/healthcare Internet. Ultimately, all those involved in the creation, maintenance, and marketing of medical and healthcare Web sites should be required to adhere to a strict code of ethical conduct, one that has been fairly determined by an impartial international organization with reasonable power to regulate the code. This code could also serve as a desirable, recognizable label-of-distinction for ethical Web sites within the medical and healthcare Internet community. One challenge for those involved with the medical and healthcare Internet will be to determine what constitutes "Medical Internet Ethics" or "Healthcare Internet Ethics," since the definition of medical ethics can vary from country to country. Therefore, the emerging field of Medical/ Healthcare Internet Ethics will require careful thought and insights from an international collection of ethicists in many contributing areas. This paper is a review of the current status of the evolving field of Medical/Healthcare Internet Ethics, including proposed definitions and identification of many diverse areas that may ultimately contribute to this multidisciplinary field. The current role

  9. Factors that impact on emergency nurses' ethical decision-making ability.

    Science.gov (United States)

    Alba, Barbara

    2016-11-10

    Reliance on moral principles and professional codes has given nurses direction for ethical decision-making. However, rational models do not capture the emotion and reality of human choice. Intuitive response must be considered. Supporting intuition as an important ethical decision-making tool for nurses, the aim of this study was to determine relationships between intuition, years of worked nursing experience, and perceived ethical decision-making ability. A secondary aim explored the relationships between rational thought to years of worked nursing experience and perceived ethical decision-making ability. A non-experimental, correlational research design was used. The Rational Experiential Inventory measured intuition and rational thought. The Clinical Decision Making in Nursing Scale measured perceived ethical decision-making ability. Pearson's r was the statistical method used to analyze three primary and two secondary research questions. A sample of 182 emergency nurses was recruited electronically through the Emergency Nurses Association. Participants were self-selected. Approval to conduct this study was obtained by the Adelphi University Institutional Review Board. A relationship between intuition and perceived ethical decision-making ability (r = .252, p = .001) was a significant finding in this study. This study is one of the first of this nature to make a connection between intuition and nurses' ethical decision-making ability. This investigation contributes to a broader understanding of the different thought processes used by emergency nurses to make ethical decisions. © The Author(s) 2016.

  10. Clarifying perspectives: Ethics case reflection sessions in childhood cancer care.

    Science.gov (United States)

    Bartholdson, Cecilia; Lützén, Kim; Blomgren, Klas; Pergert, Pernilla

    2016-06-01

    Childhood cancer care involves many ethical concerns. Deciding on treatment levels and providing care that infringes on the child's growing autonomy are known ethical concerns that involve the whole professional team around the child's care. The purpose of this study was to explore healthcare professionals' experiences of participating in ethics case reflection sessions in childhood cancer care. Data collection by observations, individual interviews, and individual encounters. Data analysis were conducted following grounded theory methodology. Healthcare professionals working at a publicly funded children's hospital in Sweden participated in ethics case reflection sessions in which ethical issues concerning clinical cases were reflected on. The children's and their parents' integrity was preserved through measures taken to protect patient identity during ethics case reflection sessions. The study was approved by a regional ethical review board. Consolidating care by clarifying perspectives emerged. Consolidating care entails striving for common care goals and creating a shared view of care and the ethical concern in the specific case. The inter-professional perspectives on the ethical aspects of care are clarified by the participants' articulated views on the case. Different approaches for deliberating ethics are used during the sessions including raising values and making sense, leading to unifying interactions. The findings indicate that ethical concerns could be eased by implementing ethics case reflection sessions. Conflicting perspectives can be turned into unifying interactions in the healthcare professional team with the common aim to achieve good pediatric care. Ethics case reflection sessions is valuable as it permits the discussion of values in healthcare-related issues in childhood cancer care. Clarifying perspectives, on the ethical concerns, enables healthcare professionals to reflect on the most reasonable and ethically defensible care for the child

  11. 76 FR 80902 - Senior Executive Service; Performance Review Board; Members

    Science.gov (United States)

    2011-12-27

    ... COURT SERVICES AND OFFENDER SUPERVISION AGENCY FOR THE DISTRICT OF COLUMBIA Senior Executive Service; Performance Review Board; Members AGENCY: Court Services and Offender Supervision Agency for the... agency's Senior Executive Service. The PRB established for the Court Services and Offender Supervision...

  12. 76 FR 55677 - Senior Executive Service (SES) Performance Review Board

    Science.gov (United States)

    2011-09-08

    ... GENERAL SERVICES ADMINISTRATION [Notice-CPO-2011-01; Docket 2011-0006; Sequence 15] Senior Executive Service (SES) Performance Review Board AGENCY: General Services Administration. ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of new members to the General Services Administration...

  13. Code of Ethics for the American Association of Physicists in Medicine: report of Task Group 109.

    Science.gov (United States)

    Serago, Christopher F; Adnani, Nabil; Bank, Morris I; BenComo, Jose A; Duan, Jun; Fairobent, Lynne; Freedman, D Jay; Halvorsen, Per H; Hendee, William R; Herman, Michael G; Morse, Richard K; Mower, Herbert W; Pfeiffer, Douglas E; Root, William J; Sherouse, George W; Vossler, Matthew K; Wallace, Robert E; Walters, Barbara

    2009-01-01

    A comprehensive Code of Ethics for the members of the American Association of Physicists in Medicine (AAPM) is presented as the report of Task Group 109 which consolidates previous AAPM ethics policies into a unified document. The membership of the AAPM is increasingly diverse. Prior existing AAPM ethics polices were applicable specifically to medical physicists, and did not encompass other types of members such as health physicists, regulators, corporate affiliates, physicians, scientists, engineers, those in training, or other health care professionals. Prior AAPM ethics policies did not specifically address research, education, or business ethics. The Ethics Guidelines of this new Code of Ethics have four major sections: professional conduct, research ethics, education ethics, and business ethics. Some elements of each major section may be duplicated in other sections, so that readers interested in a particular aspect of the code do not need to read the entire document for all relevant information. The prior Complaint Procedure has also been incorporated into this Code of Ethics. This Code of Ethics (PP 24-A) replaces the following AAPM policies: Ethical Guidelines for Vacating a Position (PP 4-B); Ethical Guidelines for Reviewing the Work of Another Physicist (PP 5-C); Guidelines for Ethical Practice for Medical Physicists (PP 8-D); and Ethics Complaint Procedure (PP 21-A). The AAPM Board of Directors approved this Code or Ethics on July 31, 2008.

  14. Surgical innovation: the ethical agenda: A systematic review.

    Science.gov (United States)

    Broekman, Marike L; Carrière, Michelle E; Bredenoord, Annelien L

    2016-06-01

    The aim of the present article was to systematically review the ethics of surgical innovation and introduce the components of the learning health care system to guide future research and debate on surgical innovation.Although the call for evidence-based practice in surgery is increasingly high on the agenda, most surgeons feel that the format of the randomized controlled trial is not suitable for surgery. Innovation in surgery has aspects of, but should be distinguished from both research and clinical care and raises its own ethical challenges.To answer the question "What are the main ethical aspects of surgical innovation?", we systematically searched PubMed and Embase. Papers expressing an opinion, point of view, or position were included, that is, normative ethical papers.We included 59 studies discussing ethical aspects of surgical innovation. These studies discussed 4 major themes: oversight, informed consent, learning curve, and vulnerable patient groups. Although all papers addressed the ethical challenges raised by surgical innovation, surgeons hold no uniform view of surgical innovation, and there is no agreement on the distinction between innovation and research. Even though most agree to some sort of oversight, they offer different alternatives ranging from the formation of new surgical innovation committees to establishing national registries. Most agree that informed consent is necessary for innovative procedures and that surgeons should be adequately trained to assure their competence to tackle the learning curve problem. All papers agree that in case of vulnerable patients, alternatives must be found for the informed consent procedure.We suggest that the concept of the learning health care system might provide guidance for thinking about surgical innovation. The underlying rationale of the learning health care system is to improve the quality of health care by embedding research within clinical care. Two aspects of a learning health care system might

  15. 75 FR 48683 - Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft Final...

    Science.gov (United States)

    2010-08-11

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0617; FRL-9188-3] Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft Final Report From the June 23, 2010 HSRB Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Human Studies...

  16. 75 FR 73078 - Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft Report...

    Science.gov (United States)

    2010-11-29

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0919; FRL-9232-5] Human Studies Review Board (HSRB); Notification of a Public Teleconference To Review Draft Report From the October 27-28, 2010 HSRB Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Human Studies...

  17. 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/

  18. The exceptional ethics of the investigator-subject relationship.

    Science.gov (United States)

    Sachs, Benjamin

    2010-02-01

    This article concerns the validity of six canonical rules that institutional review boards use to constrain the behavior of investigators. These rules require investigators to design their studies in a scientifically valid way, not pay their subjects to take risks, minimize risks to their subjects, secure for their subjects access to effective interventions post-trial, not pay their subjects too much and allow their subjects to withdraw from the study unconditionally. Enforcement of these rules is problematic because there are other relationships that seem to be like the investigator-subject relationship in all ethically relevant respects, such as the employer-employee and volunteer organizer-volunteer relationships, to which we would not dream of applying these same rules. Applying these rules in one context but not the others is a violation of ethical consistency I label "exceptionalism." We should conclude that it is time to reexamine the validity of the six rules.

  19. 76 FR 64429 - Senior Executive Service; Public Debt Performance Review Board (PRB)

    Science.gov (United States)

    2011-10-18

    ... DEPARTMENT OF THE TREASURY Bureau of the Public Debt Senior Executive Service; Public Debt Performance Review Board (PRB) AGENCY: Bureau of the Public Debt, Treasury. ACTION: Notice of Members of... reviews the performance appraisals of career senior executives who are below the level of Assistant...

  20. Minors and euthanasia: a systematic review of argument-based ethics literature.

    Science.gov (United States)

    Cuman, Giulia; Gastmans, Chris

    2017-07-01

    Euthanasia was first legalised in the Netherlands in 2002, followed by similar legislation in Belgium the same year. Since the beginning, however, only the Netherlands included the possibility for minors older than 12 years to request euthanasia. In 2014, the Belgian Act legalising euthanasia was amended to include requests by minors who possess the capacity of discernment. This amendment sparked great debate, and raised difficult ethical questions about when and how a minor can be deemed competent. We conducted a systematic review of argument-based literature on euthanasia in minors. The search process followed PRISMA guidelines. Thirteen publications were included. The four-principle approach of medical ethics was used to organise the ethical arguments underlying this debate. The justification for allowing euthanasia in minors is buttressed mostly by the principles of beneficence and respect for autonomy. Somewhat paradoxically, both principles are also used in the literature to argue against the extension of legislation to minors. Opponents of euthanasia generally rely on the principle of non-maleficence. The present analysis reveals that the debate surrounding euthanasia in minors is at an early stage. In order to allow a more in-depth ethical discussion, we suggest enriching the four-principle approach by including a care-ethics approach. What is Known: • The Netherlands and Belgium are the only two countries in the world with euthanasia legislation making it possible for minors to receive euthanasia. • This legislation provoked great debate globally, with ethical arguments for and against this legislation. What is New: • A systematic description of the ethical concepts and arguments grounding the debate on euthanasia in minors, as reported in the argument-based ethics literature. • A need has been identified to enrich the debate with a care-ethics approach to avoid oversimplifying the ethical decision-making process.

  1. 76 FR 57947 - Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2011-09-19

    ... AND EFFICIENCY Senior Executive Service Performance Review Board Membership AGENCY: Council of the... of Personnel Management, each agency is required to establish one or more Senior Executive Service... appraisal of a senior executive's performance by the supervisor, along with any recommendations to the...

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

    Science.gov (United States)

    Agnew Cochran, Elizabeth; Fozard Weaver, Darlene

    2017-01-01

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

  3. 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

  4. Healthcare professionals' perceptions of the ethical climate in paediatric cancer care.

    Science.gov (United States)

    Bartholdson, Cecilia; Sandeberg, Margareta Af; Lützén, Kim; Blomgren, Klas; Pergert, Pernilla

    2016-12-01

    How well ethical concerns are handled in healthcare is influenced by the ethical climate of the workplace, which in this study is described as workplace factors that contribute to healthcare professionals' ability to identify and deal with ethical issues in order to provide the patient with ethically good care. The overall aim of the study was to describe perceptions of the paediatric hospital ethical climate among healthcare professionals who treat/care for children with cancer. Data were collected using the Hospital Ethical Climate Survey developed by Olsson as a separate section in a questionnaire. Descriptive statistics were used to analyse perceptions of the ethical climate. Participants and research context: Physicians, nurses and nurse-aides (n = 89) from three paediatric units participated in this study: haematology/oncology, chronic diseases and neurology. Ethical considerations: The study was approved by the regional ethical review board. Different perceptions of the ethical climate were rated as positive or negative/neutral. Nurses' ratings were less positive than physicians on all items. One-third of the participants perceived that they were able to practice ethically good care as they believed it should be practised. Differences in professional roles, involving more or less power and influence, might explain why physicians and nurses rated items differently. A positive perception of the possibility to practice ethically good care seems to be related to inter-professional trust and listening to guardians/parents. A negative/neutral perception of the possibility to practice ethically good care appears to be influenced by experiences of ethical conflicts as well as a lack of ethical support, for example, time for reflection and discussion. The two-thirds of participants who had a negative/neutral perception of the possibility to practice ethically good care are at risk of developing moral stress. Clinical ethics support needs to be implemented in care

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

    Science.gov (United States)

    Langat, Simon K

    2005-10-01

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

  6. Qualitative Evaluation Methods in Ethics Education: A Systematic Review and Analysis of Best Practices.

    Science.gov (United States)

    Watts, Logan L; Todd, E Michelle; Mulhearn, Tyler J; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

    2017-01-01

    Although qualitative research offers some unique advantages over quantitative research, qualitative methods are rarely employed in the evaluation of ethics education programs and are often criticized for a lack of rigor. This systematic review investigated the use of qualitative methods in studies of ethics education. Following a review of the literature in which 24 studies were identified, each study was coded based on 16 best practices characteristics in qualitative research. General thematic analysis and grounded theory were found to be the dominant approaches used. Researchers are effectively executing a number of best practices, such as using direct data sources, structured data collection instruments, non-leading questioning, and expert raters. However, other best practices were rarely present in the courses reviewed, such as collecting data using multiple sources, methods, raters, and timepoints, evaluating reliability, and employing triangulation analyses to assess convergence. Recommendations are presented for improving future qualitative research studies in ethics education.

  7. What makes public health studies ethical? Dissolving the boundary between research and practice

    Science.gov (United States)

    2014-01-01

    Background The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary – whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants – have been unsatisfactory. Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle – from initial planning through to knowledge exchange. Discussion The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives. The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services

  8. What makes public health studies ethical? Dissolving the boundary between research and practice.

    Science.gov (United States)

    Willison, Donald J; Ondrusek, Nancy; Dawson, Angus; Emerson, Claudia; Ferris, Lorraine E; Saginur, Raphael; Sampson, Heather; Upshur, Ross

    2014-08-08

    The generation of evidence is integral to the work of public health and health service providers. Traditionally, ethics has been addressed differently in research projects, compared with other forms of evidence generation, such as quality improvement, program evaluation, and surveillance, with review of non-research activities falling outside the purview of the research ethics board. However, the boundaries between research and these other evaluative activities are not distinct. Efforts to delineate a boundary - whether on grounds of primary purpose, temporality, underlying legal authority, departure from usual practice, or direct benefits to participants - have been unsatisfactory.Public Health Ontario has eschewed this distinction between research and other evaluative activities, choosing to adopt a common framework and process to guide ethical reflection on all public health evaluative projects throughout their lifecycle - from initial planning through to knowledge exchange. The Public Health Ontario framework was developed by a working group of public health and ethics professionals and scholars, in consultation with individuals representing a wide range of public health roles. The first part of the framework interprets the existing Canadian research ethics policy statement (commonly known as the TCPS 2) through a public health lens. The second part consists of ten questions that guide the investigator in the application of the core ethical principles to public health initiatives.The framework is intended for use by those designing and executing public health evaluations, as well as those charged with ethics review of projects. The goal is to move toward a culture of ethical integrity among investigators, reviewers and decision-makers, rather than mere compliance with rules. The framework is consonant with the perspective of the learning organization and is generalizable to other public health organizations, to health services organizations, and beyond. Public

  9. 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...

  10. 43 CFR 4.478 - Appeals to the Board of Land Appeals; judicial review.

    Science.gov (United States)

    2010-10-01

    ... appeal to the Board from an order of an administrative law judge granting or denying a petition for a... judicial review under 5 U.S.C. 704 of a final BLM grazing decision if the administrative law judge denies a... decide the appeal promptly. (d) Unless the Board or a court orders otherwise, an appeal under paragraph...

  11. 76 FR 7623 - Department of State Performance Review Board Members

    Science.gov (United States)

    2011-02-10

    ...: February 2, 2011. Nancy J. Powell, Director General of the Foreign Service and Director of Human Resources... following individuals to the Department of State Performance Review Board for Non-Career Senior Executive Service members: Jeanne-Marie Smith, Chairperson, Senior Advisor, Deputy Secretary for Management and...

  12. (Un)ethical behavior in organizations.

    Science.gov (United States)

    Treviño, Linda Klebe; den Nieuwenboer, Niki A; Kish-Gephart, Jennifer J

    2014-01-01

    This review spotlights research related to ethical and unethical behavior in organizations. It builds on previous reviews and meta-analyses of the literature on (un)ethical behavior in organizations and discusses recent advances in the field. The review emphasizes how this research speaks to the influence of the organizational context on (un)ethical behavior, proceeding from a more macro to a more micro view on (un)ethical behavior and covering ethical infrastructures, interpersonal influences, individual differences, and cognitive and affective processes. The conclusion highlights opportunities for future research.

  13. A new prescription for empirical ethics research in pharmacy: a critical review of the literature

    OpenAIRE

    Cooper, R J; Bissell, P; Wingfield, J

    2007-01-01

    Empirical ethics research is increasingly valued in bioethics and healthcare more generally, but there remain as yet under-researched areas such as pharmacy, despite the increasingly visible attempts by the profession to embrace additional roles beyond the supply of medicines. A descriptive and critical review of the extant empirical pharmacy ethics literature is provided here. A chronological change from quantitative to qualitative approaches is highlighted in this review, as well as differi...

  14. 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

  15. Qualitative Study to improve integrity of NET : Perspectives of Peer review and Authorship in research ethics

    International Nuclear Information System (INIS)

    Kwon, Hyuk; Min, Byung Joo

    2007-01-01

    After Dr. Hwang's Human embryonic stem cell scandal, research ethics stood out as the hot issue in both Korean scientific circles and general public. Science Publishing Group referred the limitation of peer review system and the absence of responsibility of author to one of the causes for the scandal. In order to prevent a similar fraud, Ministry of Science and Technology(MOST) established guidelines for research ethics and integrity in 2006. The guidelines included fabrication, falsification, and plagiarism(FFP) and unfair authorship. MOST committed the authority of administration and supervision to the society and the institutes of research to preserve the research integrity. The society and institute are charged with overseeing the implementation of enacted ethics guidelines. SCI(Scientific Citation Index) holds the guideline of research ethics and canon of the society which were crafted in order to guaranty the integrity and quality of the research. The publication policy pertains submission of articles, authorship and responsibilities of a reviewer. Societies pay attention to the peer review policy because the quality of articles is strongly dependent on the peer review. Nuclear Engineering and Technology (NET) is the journal of Korea Nuclear Society(KNS). NET is registered with SCIE(Science Citation Index Expanded), recently. In addition to the growth in external circulation, the improvement of quality requires the effort of the society to establish a strict peer review system and a fair authorship. The qualitative study on peer review and authorship of NET was put into force to improve the quality of NET. Based on studies and suggestions, the policy focuses on research ethics to improve the integrity of NET

  16. Qualitative Study to improve integrity of NET : Perspectives of Peer review and Authorship in research ethics

    Energy Technology Data Exchange (ETDEWEB)

    Kwon, Hyuk; Min, Byung Joo [Korea Atomic Energy Research Institute, Daejeon (Korea, Republic of)

    2007-10-15

    After Dr. Hwang's Human embryonic stem cell scandal, research ethics stood out as the hot issue in both Korean scientific circles and general public. Science Publishing Group referred the limitation of peer review system and the absence of responsibility of author to one of the causes for the scandal. In order to prevent a similar fraud, Ministry of Science and Technology(MOST) established guidelines for research ethics and integrity in 2006. The guidelines included fabrication, falsification, and plagiarism(FFP) and unfair authorship. MOST committed the authority of administration and supervision to the society and the institutes of research to preserve the research integrity. The society and institute are charged with overseeing the implementation of enacted ethics guidelines. SCI(Scientific Citation Index) holds the guideline of research ethics and canon of the society which were crafted in order to guaranty the integrity and quality of the research. The publication policy pertains submission of articles, authorship and responsibilities of a reviewer. Societies pay attention to the peer review policy because the quality of articles is strongly dependent on the peer review. Nuclear Engineering and Technology (NET) is the journal of Korea Nuclear Society(KNS). NET is registered with SCIE(Science Citation Index Expanded), recently. In addition to the growth in external circulation, the improvement of quality requires the effort of the society to establish a strict peer review system and a fair authorship. The qualitative study on peer review and authorship of NET was put into force to improve the quality of NET. Based on studies and suggestions, the policy focuses on research ethics to improve the integrity of NET.

  17. ETHICS OF SMART HOUSE WELFARE TECHNOLOGY FOR OLDER ADULTS: A SYSTEMATIC LITERATURE REVIEW.

    Science.gov (United States)

    Sánchez, Veralia Gabriela; Taylor, Ingrid; Bing-Jonsson, Pia Cecilie

    2017-01-01

    The University College of Southeast Norway has an on-going project to develop a smart house welfare system to allow older adults and people with disabilities to remain in their homes for as long as they wish in safe, dignified, living conditions. This article reviews reported ethical challenges to implementing smart houses for older adults. A systematic literature review identified twenty-four articles in English, French, Spanish, and Norwegian, which were analyzed and synthesized using Hofmann's question list to investigate the reported ethical challenges. Smart houses offer a promising way to improve access to home care for older adults and people with disabilities. However, important ethical challenges arise when implementing smart houses, including cost-effectiveness, privacy, autonomy, informed consent, dignity, safety, and trust. The identified ethical challenges are important to consider when developing smart house systems. Due to the limitations of smart house technology, designers and users should be mindful that smart houses can achieve a safer and more dignified life-style but cannot solve all the challenges related to ageing, disabilities, and disease. At some point, smart houses can no longer help persons as they develop needs that smart houses cannot meet.

  18. Areva - Press release from the Supervisory Board

    International Nuclear Information System (INIS)

    Marie, Patricia; Briand, Pauline; Floquet-Daubigeon, Fleur; Michaut, Maxime; Scorbiac, Marie de; Repaire, Philippine du

    2012-01-01

    During its meeting held on December 12, 2011, devoted in particular to the examination of the 2011 closing estimates, the AREVA Executive Board indicated that it expected to book a provision of 1.46 billion euros (2.025 billion US dollars) in the company's accounts for fiscal year 2011 for impairment of assets for the reporting entity UraMin, a mining company acquired by AREVA in 2007, which, given the provision booked in 2010 (426 million euros), brings the value of these assets on the AREVA balance sheet down to 410 million euros. Given the size of these provisions, the Supervisory Board decided to make three of its members, meeting as an ad hoc committee, in charge of analyzing the terms of acquisition of this company, as well as the key decisions made in this reporting entity up to 2011 and, based on the outcome of these analyses, to recommend to it any appropriate measures in AREVA's interest. This committee reported on its work during the Supervisory Board meeting held on February 14, 2012. In light of this report, the Supervisory Board found that the fairness and reliability of the financial statements of previous years were not in question. Nevertheless, considering the malfunctions raised, the Board considers it appropriate to thoroughly review AREVA's governance in order to ensure that decisions concerning large acquisitions or investments be reviewed and validated in the future under conditions ensuring better legal and financial security and enabling a more transparent dialogue between management and the Supervisory Board. It thus asked the Executive Board to recommend, at the next General Meeting of Shareholders, that the by-laws of the company be modified to make the Supervisory Board's prior approval of investments, stake acquisitions and acquisitions mandatory above a threshold of 20 million euros. It also decided to set up a business ethics committee within the Supervisory Board responsible for ensuring that rules of conduct are properly applied

  19. Review Article: Ethical Issues in the Study of Second Language Acquisition--Resources for Researchers

    Science.gov (United States)

    Thomas, Margaret

    2009-01-01

    Two recent books provide varied resources for exploring ethical issues in the social sciences. Reflection on ethical issues aims to sensitize scholars to a range of consequences of their research, and to scholars' responsibilities to their discipline, their colleagues, and the public. This review article assesses the utility of these texts (and of…

  20. The spectrum of ethical issues in a Learning Health Care System: a systematic qualitative review.

    Science.gov (United States)

    McLennan, Stuart; Kahrass, Hannes; Wieschowski, Susanne; Strech, Daniel; Langhof, Holger

    2018-04-01

    To determine systematically the spectrum of ethical issues that is raised for stakeholders in a 'Learning Health Care System' (LHCS). The systematic review was conducted in PubMed and Google Books between the years 2007 and 2015. The literature search retrieved 1258 publications. Each publication was independently screened by two reviewers for eligibility for inclusion. Ethical issues were defined as arising when a relevant normative principle is not adequately considered or two principles come into conflict. A total of 65 publications were included in the final analysis and were analysed using an adapted version of qualitative content analysis. A coding frame was developed inductively from the data, only the highest-level categories were generated deductively for a life-cycle perspective. A total of 67 distinct ethical issues could be categorized under different phases of the LHCS life-cycle. An overarching theme that was repeatedly raised was the conflict between the current regulatory system and learning health care. The implementation of a LHCS can help realize the ethical imperative to continuously improve the quality of health care. However, the implementation of a LHCS can also raise a number of important ethical issues itself. This review highlights the importance for health care leaders and policy makers to balance the need to protect and respect individual participants involved in learning health care activities with the social value of improving health care.

  1. Ethics and health promotion practice: exploring attitudes and practices in Western Australian health organisations.

    Science.gov (United States)

    Reilly, T; Crawford, G; Lobo, R; Leavy, J; Jancey, J

    2016-04-01

    Issue addressed Evidence-informed practice underpinned by ethics is fundamental to developing the science of health promotion. Knowledge and application of ethical principles are competencies required for health promotion practice. However, these competencies are often inconsistently understood and applied. This research explored attitudes, practices, enablers and barriers related to ethics in practice in Western Australian health organisations. Methods Semistructured, in-depth interviews were conducted with 10 health promotion practitioners, purposefully selected to provide a cross-section of government and non-government organisations. Interviews were recorded, transcribed and then themed. Results The majority of participants reported consideration of ethics in their practice; however, only half reported seeking Human Research Ethics Committee (HREC) approval for projects in the past 12 months. Enablers identified as supporting ethics in practice and disseminating findings included: support preparing ethics applications; resources and training about ethical practice; ability to access HRECs for ethics approval; and a supportive organisational culture. Barriers included: limited time; insufficient resourcing and capacity; ethics approval not seen as part of core business; and concerns about academic writing. Conclusion The majority of participants were aware of the importance of ethics in practice and the dissemination of findings. However, participants reported barriers to engaging in formal ethics processes and to publishing findings. So what? Alignment of evidence-informed and ethics-based practice is critical. Resources and information about ethics may be required to support practice and encourage dissemination of findings, including in the peer-reviewed literature. Investigating the role of community-based ethics boards may be valuable to bridging the ethics-evidence gap.

  2. The full spectrum of ethical issues in the care of patients with ALS: a systematic qualitative review.

    Science.gov (United States)

    Seitzer, F; Kahrass, H; Neitzke, G; Strech, D

    2016-02-01

    Dealing systematically with ethical issues in amyotrophic lateral sclerosis (ALS) care requires an unbiased awareness of all the relevant ethical issues. The aim of the study was to determine systematically and transparently the full spectrum of ethical issues in ALS care. We conducted a systematic review in Medline and Google Books (restricted to English and German literature published between 1993 and 2014). We applied qualitative text analysis and normative analysis to categorise the spectrum of ethical issues in ALS care. The literature review retrieved 56 references that together mentioned a spectrum of 103 ethical issues in ALS care. The spectrum was structured into six major categories that consist of first and second-order categories of ethical issues. The systematically derived spectrum of ethical issues in ALS care presented in this paper raises awareness and understanding of the complexity of ethical issues in ALS care. It also offers a basis for the systematic development of informational and training materials for health professionals, patients and their relatives, and society as a whole. Finally, it supports a rational and fair selection of all those ethical issues that should be addressed in health policies, position papers and clinical practice guidelines. Further research is needed to identify ways to systematically select the most relevant ethical issues not only in the clinical environment, but also for the development of clinical practice guidelines.

  3. Methods for Practising Ethics in Research and Innovation : A Literature Review, Critical Analysis and Recommendations

    NARCIS (Netherlands)

    Reijers, Wessel; Wright, David; Brey, Philip; Weber, Karsten; Rodrigues, Rowena; O’Sullivan, Declan; Gordijn, Bert

    2017-01-01

    This paper provides a systematic literature review, analysis and discussion of methods that are proposed to practise ethics in research and innovation (R&I). Ethical considerations concerning the impacts of R&I are increasingly important, due to the quickening pace of technological innovation and

  4. 78 FR 69426 - Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board...

    Science.gov (United States)

    2013-11-19

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

  5. A Case for Limiting the Reach of Institutional Review Boards

    Science.gov (United States)

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

    2011-01-01

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

  6. Ethics, equality and evidence in health promotion Danish guidelines for municipalities.

    Science.gov (United States)

    Vallgårda, Signild

    2014-06-01

    The Danish National Board of Health has expressed its commitment to social equality in health, evidence-informed health promotion and public health ethics, and has issued guidelines for municipalities on health promotion, in Danish named prevention packages. The aim of this article is to analyse whether the Board of Health adheres to ideals of equality, evidence and ethics in these guidelines. An analysis to detect statements about equity, evidence and ethics in 10 health promotion packages directed at municipalities with the aim of guiding the municipalities towards evidence-informed disease prevention and health promotion. Despite declared intentions of prioritizing social equality in health, these intentions are largely absent from most of the packages. When health inequalities are mentioned, focus is on the disadvantaged or the marginalized. Several interventions are recommended, where there is no evidence to support them, notwithstanding the ambition of interventions being evidence-informed. Ethical considerations are scanty, scattered and unsystematically integrated. Further, although some packages mention the importance of avoiding stigmatization, there is little indicating how this could be done. Including reduction of health inequalities and evidence-informed and ethically defendable interventions in health promotion is a challenge, which is not yet fully met by the National Board of Health. When judged from liberal ethical principles, only few of the suggested interventions are acceptable, i.e., those concerning information, but from a paternalistic view, all interventions that may actually benefit the citizens are justified. © 2014 the Nordic Societies of Public Health.

  7. Guidelines for the Ethical Publication of Facial Photographs and Review of the Literature.

    Science.gov (United States)

    Bennett, Katelyn G; Bonawitz, Steven C; Vercler, Christian J

    2018-01-01

    Facial photography presents a unique ethical dilemma, as faces are difficult to deidentify for publication. We performed a review of the literature to examine current guidelines for the publication of facial photographs. We also reviewed societies' websites, journal requirements, and ethical and legal aspects of confidentiality. Most articles emphasized the importance of consent for photography and publication. Masking is not appropriate, but some journals continue to allow masking. Most legislation allows patients to restrict the uses of photographs. In the end, it is imperative to protect patient privacy by obtaining consent for photograph publication after full disclosure of risks, and specific recommendations are provided regarding a comprehensive consent process.

  8. Board of Directors or Supervisory Board

    DEFF Research Database (Denmark)

    Werlauff, Erik

    2009-01-01

    The article analyses the legal consequences of the choice now available to Danish public limited companies, which can now opt for a two-tier management structure, in which the management board undertakes both the day-to-day and the overall management, while a supervisory board exercises control...... over the management board, including its appointment and dismissal. The article considers which companies a two-tier structure may be relevant for, and reviews the consequences for the composition, election and functioning of the company organs....

  9. Business ethics education

    Directory of Open Access Journals (Sweden)

    Isaias Rivera

    2015-11-01

    Full Text Available This paper makes the review of the literature dedicated to relevant social issues that have been addressed by business practices and the business ethics literature, especially during the past century. The review of practical literature is undertaken from the perspective of the practitioner and demonstrates that the business ethics literature has been lax in the sense that it mostly addresses specific managerial problems and personal ethics within the business environment.

  10. 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.

  11. Ethics of social media research: common concerns and practical considerations.

    Science.gov (United States)

    Moreno, Megan A; Goniu, Natalie; Moreno, Peter S; Diekema, Douglas

    2013-09-01

    Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols.

  12. Ethics of Social Media Research: Common Concerns and Practical Considerations

    Science.gov (United States)

    Goniu, Natalie; Moreno, Peter S.; Diekema, Douglas

    2013-01-01

    Abstract Social media Websites (SMWs) are increasingly popular research tools. These sites provide new opportunities for researchers, but raise new challenges for Institutional Review Boards (IRBs) that review these research protocols. As of yet, there is little-to-no guidance regarding how an IRB should review the studies involving SMWs. The purpose of this article was to review the common risks inherent in social media research and consider how researchers can consider these risks when writing research protocols. We focused this article on three common research approaches: observational research, interactive research, and survey/interview research. Concomitant with these research approaches, we gave particular attention to the issues pertinent to SMW research, including privacy, consent, and confidentiality. After considering these challenges, we outlined key considerations for both researchers and reviewers when creating or reviewing SMW IRB protocols. Our goal in this article was to provide a detailed examination of relevant ethics and regulatory issues for both researchers and those who review their protocols. PMID:23679571

  13. Public health accreditation and metrics for ethics: a case study on environmental health and community engagement.

    Science.gov (United States)

    Bernheim, Ruth Gaare; Stefanak, Matthew; Brandenburg, Terry; Pannone, Aaron; Melnick, Alan

    2013-01-01

    As public health departments around the country undergo accreditation using the Public Health Accreditation Board standards, the process provides a new opportunity to integrate ethics metrics into day-to-day public health practice. While the accreditation standards do not explicitly address ethics, ethical tools and considerations can enrich the accreditation process by helping health departments and their communities understand what ethical principles underlie the accreditation standards and how to use metrics based on these ethical principles to support decision making in public health practice. We provide a crosswalk between a public health essential service, Public Health Accreditation Board community engagement domain standards, and the relevant ethical principles in the Public Health Code of Ethics (Code). A case study illustrates how the accreditation standards and the ethical principles in the Code together can enhance the practice of engaging the community in decision making in the local health department.

  14. The nature and scope of psychiatric ethics: review article | Radden ...

    African Journals Online (AJOL)

    Both the professional code of conduct required in the practice of psychiatry, and the broader set of moral and ethical problems distinctive to, or at least magnified by, the mental health care setting are reviewed here. Some perennial aspects of mental disorder and its cultural history are introduced, together with problems ...

  15. Report of Apollo 204 Review Board to the Administrator, National Aeronautics and Space Administration . Appendix F ; Schedule of Physical Evidence

    Science.gov (United States)

    1967-01-01

    Immediately following the Apollo 204 accident of January 27, 1961. all associated equipment and material were impounded. Release of this equipment and material for normal use was under the close control of the Apollo 204 Review Board. Apollo Review Board Administrative Procedure No. 11, February 11, 1961, established the Apollo 204 Review Board Material Release Record (MRR). This MRR was the official form used to release material from full impoundment and was valid only after being approved by the Board and signed by a Member. The form was used as the authority to place any impounded item into one of the three Categories defined in Administrative Procedure No. 11. This appendix contains all of the authorized MRR's. Each item submitted on an MRR was given a control number; a description, including the part number and serial number; the relevance and location to the accident; any constraints before release; and the control category. The categories placed on the equipment were as follows: Category A - Items which may have a significant influence or bearing on the results or findings of the Apollo 204 Review Board; Category B - All material other than Category A which is considered relevant to the Apollo 204 Review Board investigation; Category C - Material released from Board jurisdiction. Several classes of equipment were released by special Board action prior to the establishment of the MRR system. The operating procedure for release of these classes is Enclosure F-l to this appendix.

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

    Science.gov (United States)

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

    2016-07-01

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

  17. Auditing the process of ethics approval for Master’s degrees at a South African university

    Directory of Open Access Journals (Sweden)

    Damian Clarke

    2014-04-01

    Full Text Available Introduction. This study audited the process of ethics approval for Master’s research at the Nelson R Mandela School of Medicine, Durban, KwaZulu-Natal, South Africa.Methods. After obtaining the appropriate ethical approval, all the correspondence surrounding each Master’s proposal for the year 2010 was reviewed. Results. A total of 53 proposals for Master’s degrees were available for review. All the proposals were for low-risk studies, and all were subjected to expedited review. It took an average of 15 weeks (range 3 - 32 for the institutional ethics review board (the Biomedical Research Ethics Committee (BREC to respond to each of the 53 proposals. Twenty-three studies (43.4% received provisional approval on the first response, 2 proposals (3.8% were rejected, and 28 proposals (52.8% were sent back with major queries. For the 28 proposals that required major revisions, 11 responses had been submitted by the time the data were collected. The average length of time to receive a response from the applicants to BREC queries was 4 weeks.Conclusion. This study suggests that there is a potential cumulative delay of over 4 months before data collection for low-risk clinical audits can be commenced. Any system designed to improve this situation must ensure that high standards of vigilance are maintained, but must be flexible enough to allow for a faster review and approval process.

  18. Should School Boards Discontinue Support for High School Football?

    Science.gov (United States)

    Margolis, Lewis H; Canty, Greg; Halstead, Mark; Lantos, John D

    2017-01-01

    A pediatrician is asked by her local school board to help them decide whether to discontinue their high school football program. She reviews the available evidence on the risks of football and finds it hopelessly contradictory. Some scholars claim that football is clearly more dangerous than other sports. Others suggest that the risks of football are comparable to other sports, such as lacrosse, ice hockey, or soccer. She finds very little data on the long-term sequelae of concussions. She sees claims that good coaching and a school culture that prioritizes the health of athletes over winning can reduce morbidity from sports injuries. In this paper, 3 experts also review the evidence about sports risks and discuss what is known and not known about the science and the ethics of high school football. Copyright © 2017 by the American Academy of Pediatrics.

  19. Cell-based interventions for neurologic conditions: ethical challenges for early human trials.

    Science.gov (United States)

    Mathews, D J H; Sugarman, J; Bok, H; Blass, D M; Coyle, J T; Duggan, P; Finkel, J; Greely, H T; Hillis, A; Hoke, A; Johnson, R; Johnston, M; Kahn, J; Kerr, D; Kurtzberg, J; Liao, S M; McDonald, J W; McKhann, G; Nelson, K B; Rao, M; Regenberg, A; Siegel, A W; Smith, K; Solter, D; Song, H; Vescovi, A; Young, W; Gearhart, J D; Faden, R

    2008-07-22

    Attempts to translate basic stem cell research into treatments for neurologic diseases and injury are well under way. With a clinical trial for one such treatment approved and in progress in the United States, and additional proposals under review, we must begin to address the ethical issues raised by such early forays into human clinical trials for cell-based interventions for neurologic conditions. An interdisciplinary working group composed of experts in neuroscience, cell biology, bioethics, law, and transplantation, along with leading disease researchers, was convened twice over 2 years to identify and deliberate on the scientific and ethical issues raised by the transition from preclinical to clinical research of cell-based interventions for neurologic conditions. While the relevant ethical issues are in many respects standard challenges of human subjects research, they are heightened in complexity by the novelty of the science, the focus on the CNS, and the political climate in which the science is proceeding. Distinctive challenges confronting US scientists, administrators, institutional review boards, stem cell research oversight committees, and others who will need to make decisions about work involving stem cells and their derivatives and evaluate the ethics of early human trials include evaluating the risks, safety, and benefits of these trials, determining and evaluating cell line provenance, and determining inclusion criteria, informed consent, and the ethics of conducting early human trials in the public spotlight. Further study and deliberation by stakeholders is required to move toward professional and institutional policies and practices governing this research.

  20. Goals of clinical ethics support: perceptions of dutch healthcare institutions

    NARCIS (Netherlands)

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

    2013-01-01

    In previous literature, ethicists mention several goals of Clinical Ethics Support (CES). It is unknown what key persons in healthcare institutions see as main- - and sub-goals of CES. This article presents the goals of CES as perceived by board members and members of ethics support staff. This is

  1. Molecular Tumor Boards: Ethical Issues in the New Era of Data Medicine.

    Science.gov (United States)

    Stoeklé, Henri-Corto; Mamzer-Bruneel, Marie-France; Frouart, Charles-Henry; Le Tourneau, Christophe; Laurent-Puig, Pierre; Vogt, Guillaume; Hervé, Christian

    2018-02-01

    The practice and development of modern medicine requires large amounts of data, particularly in the domain of cancer. The future of personalized medicine lies neither with "genomic medicine" nor with "precision medicine", but with "data medicine" (DM) (big data, data mining). The establishment of this DM has required far-reaching changes, to establish four essential elements connecting patients and doctors: biobanks, databases, bioinformatic platforms and genomic platforms. The "transformation" of scientific research areas, such as genetics, bioinformatics and biostatistics, into clinical specialties has generated a new vision of care. Molecular tumor boards (MTB) are one response to these changes and are now providing better access to next-generation sequencing (NGS) and new cancer treatments to patients with inoperable or metastatic cancers, and those for whom the usual treatment has failed. However, MTB face a crucial ethical challenge: maintaining and improving the trust of patients, clinicians, researchers and industry in academic medical centers supported by private or public funding rather than providing genetic data directly to private companies. We believe that, in this era of DM, appropriate modern digital communication networks will be required to maintain this trust and to improve the organization and effectiveness of the system. There is, therefore, a need to reconsider the form and content of informed consent (IC) documents at all academic medical centers and to introduce dynamic and electronic informed consent (e-IC).

  2. 75 FR 60864 - Senior Executive Service Combined Performance Review Board (PRB)

    Science.gov (United States)

    2010-10-01

    ... DEPARTMENT OF THE TREASURY United States Mint Senior Executive Service Combined Performance Review Board (PRB) AGENCY: United States Mint, Department of the Treasury. ACTION: Notice. SUMMARY: Pursuant to... career senior executives below the level of bureau head and principal deputy in the bureaus, except for...

  3. Ethical Gifts?: An Analysis of Soap-for-data Transactions in Malawian Survey Research Worlds.

    Science.gov (United States)

    Biruk, Crystal

    2017-09-01

    In 2008, thousands of Malawians received soap from an American research project as a gift for survey participation. Soap was deemed an ethical, non-coercive gift by researchers and ethics boards, but took on meanings that expressed recipients' grievances and aspirations. Research participants reframed soap and research benefits as "rights" they are entitled to, wages for "work," and a symbol of exploitation. Enlisting the perspectives of Malawi's ethics board, demographers, Malawian fieldworkers, and research participants, I describe how soap is spoken about and operates in research worlds. I suggest that neither a prescriptive nor a situated frame for ethics-with their investments in standardization and attention to context, respectively-provides answers about how to compensate Malawian research participants. The conclusion gestures toward a reparative framework for thinking ethics that is responsive not just to project-based parameters but also to the histories and political economy in which projects (and ethics) are situated. © 2017 by the American Anthropological Association.

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

    Science.gov (United States)

    Klitzman, Robert

    2014-03-01

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

  5. 76 FR 2107 - Human Studies Review Board; Notice of Public Meeting

    Science.gov (United States)

    2011-01-12

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0970; FRL-9252-3] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting...

  6. 75 FR 32461 - Human Studies Review Board; Notice of Public Meeting

    Science.gov (United States)

    2010-06-08

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0381; FRL-9159-9] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency's (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting...

  7. 75 FR 61748 - Human Studies Review Board; Notice of Public Meeting

    Science.gov (United States)

    2010-10-06

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0797' FRL-9211-1] Human Studies Review Board; Notice of Public Meeting AGENCY: Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The U.S. Environmental Protection Agency (EPA or Agency) Office of the Science Advisor (OSA) announces a public meeting...

  8. DEVELOPING ETHICAL BEHAVIOURS AT BPK THROUGH HUMAN RESOURCE MANAGEMENT PRACTICES

    Directory of Open Access Journals (Sweden)

    Yusuf Setiawan Syukur

    2015-12-01

    Full Text Available According to the 1945 Constitution, the Audit Board of the Republic of Indonesia (BPK has an important role in fostering good governance and combating corruption in Indonesia’s public sector through its audit works. To be successful, BPK must implement and enforce ethical behaviours within the organisation. There are laws and regulations (e.g., civil servants’ code of ethics and employee discipline and systems, policies, and practices set up by authorities at BPK (e.g., BPK’s code of ethics, whistle-blowing procedure, the Honourary Council of BPK’s Code of Ethics (MKKE, and ethics training that regulate and influence behaviours of employees and members of the board. When reviewing literature, this paper attempts to understand the antecedents of ethical/unethical behaviours in organisations and look for best practices (including human resource management practices in developing ethical behaviours in organisations. It turns out that the ethical frameworks within BPK have a strong theoretical support. Despite the strong theoretical support from the literature, this study attempts to identify gaps between the best practices and ethical frameworks within BPK. In response to the gaps, this study attempts to offer recommendations so as to close the gaps and improve the ethical frameworks within BPK. In the end, this study produces seventeen recommendations. KEYWORDS code of ethics, ethical behaviours, human resource management, ethics audit, and ethical climate survey. ABSTRAK Berdasarkan Undang-undang Dasar 1945, Badan Pemeriksa Keuangan Republik Indonesia (BPK mempunyai peran penting dalam meningkatkan tata kelola pemerintahan yang baik dan memberantas korupsi di sektor publik di Indonesia melalui kegiatan pemeriksaannya. Agar sukses dalam mencapai tujuan tersebut, BPK harus menerapkan dan menegakkan perilaku etis di dalam organisasi. Ada undang-undang dan peraturan peraturan (contoh: kode etik Pegawai Negeri Sipil (PNS dan peraturan disiplin

  9. 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

  10. Technology and its ethics in nursing and caring journals: An integrative literature review.

    Science.gov (United States)

    Korhonen, Eila-Sisko; Nordman, Tina; Eriksson, Katie

    2015-08-01

    Over the past 20 years, the impact of technology has increased significantly in health care. The diversity of technology is growing and its knowledge scattered. The concept of technology is ambiguous in caring and nursing sciences and its ethics remains unidentified. To find evidence on how the concept of technology and its ethics are defined in caring and nursing sciences and practice. The purpose of this study is to describe and summarize the concept of technology and its ethics in the past nursing and caring literature. The integrative literature review of the past nursing and caring literature. The data were collected from caring and nursing journal articles from 2000 to 2013 focusing on technology and its ethics.The results were summarized and themed. Technology as a concept has three implications. First, technology is devices and products, including ICT and advanced, simple and assistive technology. Second, technology refers to a process consisting of methods for helping people. Third, technology as a service indicates the production of care by technology. The ethics of technology has not been established as a guiding principle. Some studies excluded ethical reflection completely. Many studies discussed the ethics of technology as benefits such as improved communication and symptoms management, and the simple use of e-health services whilst others remained critical presenting ethical problems such as unwillingness and the inability to use technology, or conflicts with human aspects or questions of inequality. In conclusion, this study indicates that technology as a concept is described diversely. The relation between technology and ethics is not a truism. Despite some evidence, more is needed to promote ethical care when using technology. © The Author(s) 2014.

  11. A Review of Future and Ethical Perspectives of Robotics and AI

    Directory of Open Access Journals (Sweden)

    Jim Torresen

    2018-01-01

    Full Text Available In recent years, there has been increased attention on the possible impact of future robotics and AI systems. Prominent thinkers have publicly warned about the risk of a dystopian future when the complexity of these systems progresses further. These warnings stand in contrast to the current state-of-the-art of the robotics and AI technology. This article reviews work considering both the future potential of robotics and AI systems, and ethical considerations that need to be taken in order to avoid a dystopian future. References to recent initiatives to outline ethical guidelines for both the design of systems and how they should operate are included.

  12. Enhancing Research Ethics Review Systems in Egypt: The Focus of an International Training Program Informed by an Ecological Developmental Approach to Enhancing Research Ethics Capacity.

    Science.gov (United States)

    Edwards, Hillary Anne; Hifnawy, Tamer; Silverman, Henry

    2015-12-01

    Recently, training programs in research ethics have been established to enhance individual and institutional capacity in research ethics in the developing world. However, commentators have expressed concern that the efforts of these training programs have placed 'too great an emphasis on guidelines and research ethics review', which will have limited effect on ensuring ethical conduct in research. What is needed instead is a culture of ethical conduct supported by national and institutional commitment to ethical practices that are reinforced by upstream enabling conditions (strong civil society, public accountability, and trust in basic transactional processes), which are in turn influenced by developmental conditions (basic freedoms of political freedoms, economic facilities, social opportunities, transparency guarantees, and protective security). Examining this more inclusive understanding of the determinants of ethical conduct enhances at once both an appreciation of the limitations of current efforts of training programs in research ethics and an understanding of what additional training elements are needed to enable trainees to facilitate national and institutional policy changes that enhance research practices. We apply this developmental model to a training program focused in Egypt to describe examples of such additional training activities. © 2014 John Wiley & Sons Ltd.

  13. 76 FR 71343 - Ethics, Independence, Arm's-Length Role, Ex Parte Communications and Open Government

    Science.gov (United States)

    2011-11-17

    ... FARM CREDIT ADMINISTRATION [FCA-PS-81; NV 11-25] Ethics, Independence, Arm's-Length Role, Ex Parte...) and the public. The FCA Board also is committed to the ethics principles and laws governing all Executive Branch employees and to the Agency's strong ethics program. DATES: Effective Date: November 7...

  14. Ethical considerations for field research on fishes

    Directory of Open Access Journals (Sweden)

    Rhett H. Bennett

    2016-12-01

    Full Text Available Collection of data from animals for research purposes can negatively impact target or by-catch species if suitable animal ethics practices are not followed. This study aimed to assess the ethical requirements of peer-reviewed scientific journals that publish primary literature on fishes, and review the ethical considerations and animal care guidelines of national and international documents on the ethical treatment of animals for research, to provide an overview of the general ethical considerations for field research on fishes. A review of 250 peer-reviewed, ISI-rated journals publishing primary research on fishes revealed that nearly half (46% had no mention of ethics, treatment of animals or ethical requirements for publication in their author guidelines or publication policies. However, 18% of the journals reviewed identify a specific set of ethical guidelines to be followed before publishing research involving animals. Ethical considerations for investigators undertaking field research on fishes, common to most animal care policies, legislation and guiding documents, include adhering to relevant legislation, minimising sample sizes, reducing or mitigating pain and distress, employing the most appropriate and least invasive techniques and accurately reporting methods and findings. This information will provide potential investigators with a useful starting point for designing and conducting ethical field research. Application of ethical best practices in field sampling studies will improve the welfare of study animals and the conservation of rare and endangered species. Conservation implications: This article provides a list of ethical considerations for designing and conducting field research on fishes. By reviewing sampling techniques and processes that are frequently used in field research on fishes and by highlighting the potential negative impacts of these sampling techniques, this article is intended to assist researchers in planning

  15. What makes great boards great.

    Science.gov (United States)

    Sonnenfeld, Jeffrey A

    2002-09-01

    In the wake of meltdowns at WorldCom, Tyco, and Enron, enormous attention has been focused on the companies' boards. It seems inconceivable that business disasters of such magnitude could happen without gross or even criminal negligence on the part of board members. And yet a close examination of those boards reveals no broad pattern of incompetence or corruption. In fact, they followed most of the accepted standards for board operations: Members showed up for meetings; they had money invested in the company; audit committees, compensation committees, and codes of ethics were in place; the boards weren't too small or too big, nor were they dominated by insiders. In other words, they passed the tests that would normally be applied to determine whether a board of directors was likely to do a good job. And that's precisely what's so scary, according to corporate governance expert Jeffrey Sonnenfeld, who suggests that it's time for some new thinking about how corporate boards operate and are evaluated. He proposes thinking not only about how to structure the board's work but also about how to manage it as a social system. Good boards are, very simply, high-functioning work groups. They're distinguished by a climate of respect, trust, and candor among board members and between the board and management. Information is shared openly and on time; emergent political factions are quickly eliminated. Members feel free to challenge one another's assumptions and conclusions, and management encourages lively discussion of strategic issues. Directors feel a responsibility to contribute meaningfully to the board's performance. In addition, good boards assess their own performance, both collectively and individually.

  16. Electronic monitoring of offenders: an ethical review.

    Science.gov (United States)

    Bülow, William

    2014-06-01

    This paper considers electronic monitoring (EM) a promising alternative to imprisonment as a criminal sanction for a series of criminal offenses. However, little has been said about EM from an ethical perspective. To evaluate EM from an ethical perspective, six initial ethical challenges are addressed and discussed. It is argued that since EM is developing as a technology and a punitive means, it is urgent to discuss its ethical implications and incorporate moral values into its design and development.

  17. 49 CFR 1019.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Cross-reference to employee ethical conduct... Cross-reference to employee ethical conduct standards and financial disclosure regulations. Members and employees of the Surface Transportation Board also should refer to the executive branch Standards of Ethical...

  18. 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,…

  19. Auditing of clinical research ethics in a children's and women's academic hospital.

    Science.gov (United States)

    Bortolussi, Robert; Nicholson, Diann

    2002-06-01

    Canadian and international guidelines for research ethics practices have advocated that research ethics boards (REBs) should implement mechanisms to review and monitor human research. Despite this, few Canadian REBs fulfil this expectation. The objective of this report is to summarize the results of 6 audits of clinical research ethics conducted between 1992 and 2000 in a children's and women's academic hospital in Canada in an effort to guide other academic centres planning a similar process. Research audits were conducted by members of a research audit review committee made up of REB volunteers. With use of random and selective processes, approximately 10% of research protocols were audited through interviews with research investigators and research coordinators and by sampling research records. Predetermined criteria were used to assess evidence of good record keeping, data monitoring, adherence to protocol, consents and the recording of adverse events during the research study. An estimate of time required to undertake an audit was made by recall of participants and records. Thirty-five research studies were reviewed including 16 multicentre clinical trials and 19 single-site clinical studies. Review of record keeping and research practice revealed some deficiencies: researchers failed to maintain original authorization (7%) or renewal documentation (9%); there was 1 instance of improper storage of medication; in 5% of 174 participants for whom consent was reviewed, an outdated consent form had been used, and in 4% the signature of the enrolee was not properly shown. Other deficiencies in consent documentation occurred in less than 2% of cases. Nineteen recommendations were made with respect to deficiencies and process issues. A total of 9 to 20 person-hours are required to review each protocol in a typical audit of this type. Information from research audits has been useful to develop educational programs to correct deficiencies identified through the audits

  20. South African Research Ethics Committee Review of Standards of Prevention in HIV Vaccine Trial Protocols.

    Science.gov (United States)

    Essack, Zaynab; Wassenaar, Douglas R

    2018-04-01

    HIV prevention trials provide a prevention package to participants to help prevent HIV acquisition. As new prevention methods are proven effective, this raises ethical and scientific design complexities regarding the prevention package or standard of prevention. Given its high HIV incidence and prevalence, South Africa has become a hub for HIV prevention research. For this reason, it is critical to study the implementation of relevant ethical-legal frameworks for such research in South Africa. This qualitative study used in-depth interviews to explore the practices and perspectives of eight members of South African research ethics committees (RECs) who have reviewed protocols for HIV vaccine trials. Their practices and perspectives are compared with ethics guideline requirements for standards of prevention.

  1. Medical Ethics in Plastic Surgery: A Mini Review.

    Science.gov (United States)

    Nejadsarvari, Nasrin; Ebrahimi, Ali; Ebrahimi, Azin; Hashem-Zade, Haleh

    2016-09-01

    Currently, cosmetic surgery is spread around the world. Several factors are involved in this rapidly evolving field such as socio-economic development, changes in cultural norms, globalization and the effects of Western culture, advertising, media, and mental disorders. Nowadays the cosmetic surgery is becoming a profitable business, which deals exclusively with human appearance and less from the perspective of beauty based on physical protests and considering factors such as sex, age, and race. The morality of plastic surgery subspecialty has undergone many moral dilemmas in the past few years. The role of the patient regardless of his unrealistic dreams has questionable ethical dimension. The problem is the loss of human values and replacing them with false values, of pride and glory to a charismatic person of higher status, that may underlie some of the posed ethical dilemmas. Cosmetic surgery has huge difference with the general principle of legal liability in professional orientation, because the objective for cosmetic surgeries is different from common therapeutic purposes. To observe excellence in the medical profession, we should always keep in mind that these service providers, often as a therapist (healer) must maintain a commitment and priority for patient safety and prior to any action, a real apply for this service recipient should be present. Also, patient-physician confidentiality is the cornerstone of medical ethics. In this review, we study the issues addressed and the ways that they can be resolved.

  2. Going beyond Procedure: Engaging with the Ethical Complexities of Being an Embedded Researcher

    Science.gov (United States)

    Rowley, Harriet

    2014-01-01

    This article is a reflection upon the ethical dimension of my work and practice as an embedded researcher during my doctorate. To begin with, I describe my experiences of gaining ethical approval from The University of Manchester while also highlighting some of the concerns that were raised by the ethics board. This leads me to recognise how the…

  3. 77 FR 71793 - Notice of Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2012-12-04

    ..., Resources, and Technology, Agency for Healthcare Research and Quality, 540 Gaither Road, Suite 4010... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Notice of Senior Executive Service Performance Review Board Membership The Agency for Healthcare Research and...

  4. 76 FR 64948 - Notice of Senior Executive Service Performance Review Board Membership

    Science.gov (United States)

    2011-10-19

    ..., Accountability, Resources, and Technology, Agency for Healthcare Research and Quality, 540 Gaither Road, Suite... DEPARTMENT OF HEALTH AND HUMAN SERVICES Agency for Healthcare Research and Quality Notice of Senior Executive Service Performance Review Board Membership The Agency for Healthcare Research and...

  5. Hidden in plain view: feminists doing engineering ethics, engineers doing feminist ethics.

    Science.gov (United States)

    Riley, Donna

    2013-03-01

    How has engineering ethics addressed gender concerns to date? How have the ideas of feminist philosophers and feminist ethicists made their way into engineering ethics? What might an explicitly feminist engineering ethics look like? This paper reviews some major themes in feminist ethics and then considers three areas in which these themes have been taken up in engineering ethics to date. First, Caroline Whitbeck's work in engineering ethics integrates considerations from her own earlier writings and those of other feminist philosophers, but does not use the feminist label. Second, efforts to incorporate the Ethic of Care and principles of Social Justice into engineering have drawn on feminist scholarship and principles, but these commitments can be lost in translation to the broader engineering community. Third, the film Henry's Daughters brings gender considerations into the mainstream of engineering ethics, but does not draw on feminist ethics per se; despite the best intentions in broaching a difficult subject, the film unfortunately does more harm than good when it comes to sexual harassment education. I seek not only to make the case that engineers should pay attention to feminist ethics and engineering ethicists make more use of feminist ethics traditions in the field, but also to provide some avenues for how to approach integrating feminist ethics in engineering. The literature review and analysis of the three examples point to future work for further developing what might be called feminist engineering ethics.

  6. Korean nurses' ethical dilemmas, professional values and professional quality of life.

    Science.gov (United States)

    Kim, Kyunghee; Han, Yonghee; Kim, Ji-su

    2015-06-01

    In the changing medical environment, professional stress continuously increases as the individual's quality of life suffers. Of all the healthcare professions, nursing is especially prone to burnout, compassion fatigue and reduced compassion satisfaction, due to the tensions resulting from the physical and psychological stress of caring for extremely ill patients. This study examined the professional quality of life of clinical nurses in Korea and the relationship between their experiences in ethical dilemmas and professional values. This was a cross-sectional study of a convenience sample consisting of 488 clinical nurses. We used four questionnaires to measure the participants' demographic characteristics, experiences in ethical dilemmas, professional nursing values and professional quality of life (ProQOL assessment, Version 5). Ethical considerations: This study received approval from the Institutional Review Board of Bronco Memorial Hospital. Written informed consent was given by all participants. The nurses' professional quality of life was affected by ethical dilemmas and professional nursing values. The factors influencing compassion satisfaction were age, client domain of ethical dilemmas, social awareness, professionalism of nursing and the roles of nursing services in professional values. The factors influencing burnout were marital status (married), religion (yes), human life domain, professional work domain of ethical dilemmas, social awareness and the role of nursing services in nursing professional values. The factors influencing secondary traumatic stress were human life domain, client domain and the professional work domain of ethical dilemmas. Intervention to help nurses increase their professional quality of life will have a greater chance of success if they are based on the nurses' values and beliefs about the ethical dilemmas they face and foster the establishment of positive professional values. © The Author(s) 2014.

  7. 77 FR 31339 - Board of Visitors, United States Military Academy (USMA)

    Science.gov (United States)

    2012-05-25

    .... Agenda: The Academy leadership will provide the Board updates on the following: Physical, Moral/Ethical... (STAP), Academic Individual Advanced Development (AIAD); the Admissions Program, including the...

  8. Psychology Ethics in Introductory Psychology Textbooks

    Science.gov (United States)

    Zucchero, Renee' A.

    2011-01-01

    Previous research revealed that introductory psychology textbooks included limited information about psychology ethics. This study reviewed 48 current introductory psychology textbooks for research and other APA ethics content. These textbooks included slightly more total ethics content and were more thorough in their review of research ethics…

  9. Ethical and regulatory problems of molecular imaging

    International Nuclear Information System (INIS)

    Jeong, Jae Min

    2004-01-01

    As a molecular imaging is the most up-to-date technology in nuclear medicine, it has complicate ethical and regulatory problems. For animal experiment, we have to follow institutional animal care committee. For clinical experiment, we have to get approval of Institutional Review Board according to Helsinki declaration. In addition, approval from Korea Food and Drug Administration (KFDA) is essential for manufacturing and commercialization. However, too much regulation would suppress development of new technology, which would result in the loss of national competitive power. In addition, most new radioactive ligands for molecular imaging are administered to human at sub-pharmacological and sub-toxicological level. In conclusion, a balanced regulation is essential for the safety of clinical application and development of new technology

  10. Submission of scientifically sound and ethical manuscripts to peer-reviewed journals - a reviewer's personal perspective on bioanalytical publications.

    Science.gov (United States)

    Weng, Naidong

    2012-11-01

    In the pharmaceutical industry, bioanalysis is very dynamic and is probably one of the few fields of research covering the entire drug discovery, development and post-marketing process. Important decisions on drug safety can partially rely on bioanalytical data, which therefore can be subject to regulatory scrutiny. Bioanalytical scientists have historically contributed significant numbers of scientific manuscripts in many peer-reviewed analytical journals. All of these journals provide some high-level instructions, but they also leave sufficient flexibility for reviewers to perform independent critique and offer recommendations for each submitted manuscript. Reviewers play a pivotal role in the process of bioanalytical publication to ensure the publication of high-quality manuscripts in a timely fashion. Their efforts usually lead to improved manuscripts. However, it has to be a joint effort among authors, reviewers and editors to promote scientifically sound and ethically fair bioanalytical publications. Most of the submitted manuscripts were well written with only minor or moderate revisions required for further improvement. Nevertheless, there were small numbers of submitted manuscripts that did not meet the requirements for publications because of scientific or ethical deficiencies, which are discussed in this Letter to the Editor. Copyright © 2012 John Wiley & Sons, Ltd.

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

    Science.gov (United States)

    Askland, Andrew

    2002-01-01

    Native American Institutional Review Boards (IRBs) promote the health and welfare of tribes by reviewing protocols for research studies that focus on their tribes. The benefits of approved protocols should not be overstated lest good studies disappoint because they do not satisfy unachievable expectations. IRBs also should avoid the temptation to censor the outcomes of those studies. Science relies on candor and clarity about results and methods to move forward.

  12. Islamic Business Ethics and Islamic Microfinance in Pesantren Gontor

    Directory of Open Access Journals (Sweden)

    Ahmad Lukman Nugraha

    2017-04-01

    Full Text Available Islam affirms that there stand for mutual affect in business processes, until the business practice as a work field recommended to the adherents; while discussing ethics of business activity poped out to minimize cheating and fraud activities. However, Islamic business ethics felt difficult to apply in practice, especially in the business of buying and selling. Modern Islamic Boarding School “Darussalam” Gontor is one of the self-financing and self-help islamic boarding schools in the economic supported by cooperatives in pesantren (koppontren. This paper aims to comprehensively understand the application of Islamic business ethics and focus on the entrepreneurs in business sectors Gontor La-Tansa’s cooperatives. This research had systematically employed mix method research with sequential explanatory design and case study. Gathering data through using questionnaires, interviews, observation and documentation has been performing analysis through data reduction, data display, and data verification. This paper argues that Gontor La-Tansa’s cooperatives sector can run the business activities with implementing business ethics according to the Qur’an and Sunna values. Appear from the height comprehension of the business to the axiom business ethics and the height application in business activities in each business sector. In addition, the role of kiai and business unit supervisor is high. Data displays a level of the height direction (80 percent and control on the application of business ethics (72 percent. The Islamic business ethics can be applied on firm’s and government’s law with height comprehension and controlling.

  13. 12 CFR 601.100 - Cross-references to employee ethical conduct standards and financial disclosure regulations.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 6 2010-01-01 2010-01-01 false Cross-references to employee ethical conduct... employee ethical conduct standards and financial disclosure regulations. Board members, officers, and other employees of the Farm Credit Administration are subject to the Standards of Ethical Conduct for Employees of...

  14. Rapid qualitative review of ethical issues surrounding healthcare for pregnant women or women of reproductive age in epidemic outbreaks.

    Science.gov (United States)

    Hummel, Patrik; Saxena, Abha; Klingler, Corinna

    2018-01-01

    This article describes, categorizes, and discusses the results of a rapid literature review aiming to provide an overview of the ethical issues and corresponding solutions surrounding pregnancies in epidemic outbreaks. The review was commissioned by the World Health Organization to inform responses to the Zika outbreak that began in 2015. Due to the urgency of the response efforts that needed to be informed by the literature search, a rapid qualitative review of the literature published in PubMed was conducted. The search and analysis were based on the operationalization of 3 key concepts: ethics, pregnancy, and epidemic outbreak. Ethical issues and solutions were interpreted within a principlist framework. The data were analyzed using qualitative content analysis. The search identified 259 publications, of which the full text of 23 papers was read. Of those, 20 papers contained a substantive part devoted to the topic of interest and were therefore analyzed further. We clustered the ethical issues and solutions around 4 themes: uncertainty, harms, autonomy/liberty, and effectiveness. Recognition of the identified ethical issues and corresponding solutions can inform and improve response efforts, public health planning, policies, and decision-making, as well as the activities of medical staff and counselors who practice before, during, or after an epidemic outbreak that affects pregnant women or those of reproductive age. The rapid review format proved to be useful despite its limited data basis and expedited review process.

  15. College Board Response to "Harvard Educational Review" Article by Santelices and Wilson

    Science.gov (United States)

    College Board, 2010

    2010-01-01

    This is the College Board's response to a research article by Drs. Maria Veronica Santelices and Mark Wilson in the Harvard Educational Review, entitled "Unfair Treatment? The Case of Freedle, the SAT, and the Standardization Approach to Differential Item Functioning" (see EJ930622).

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

    Science.gov (United States)

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

    2009-01-01

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

  17. Review of existing issues, ethics and practices in general medical research and in radiation protection research

    International Nuclear Information System (INIS)

    Schreiner-Karoussou, A.

    2008-01-01

    A literature review was carried out in relation to general medical research and radiation protection research. A large number of documents were found concerning the subject of ethics in general medical research. For radiation protection research, the number of documents and the information available is very limited. A review of practices in 13 European countries concerning general medical research and radiation protection research was carried out by sending a questionnaire to each country. It was found that all countries reviewed were well regulated for general medical research. For research that involves ionising radiation, the UK and Ireland are by far the most regulated countries. For other countries, there does not seem to be much information available. From the literature review and the review of practices, a number of existing ethical issues were identified and exposed, and a number of conclusions were drawn. (authors)

  18. 'Wicked' ethics: Compliance work and the practice of ethics in HIV research.

    Science.gov (United States)

    Heimer, Carol A

    2013-12-01

    Using ethnographic material collected between 2003 and 2007 in five HIV clinics in the US, South Africa, Uganda, and Thailand, this article examines "official ethics" and "ethics on the ground." It compares the ethical conundrums clinic staff and researchers confront in their daily work as HIV researchers with the dilemmas officially identified as ethical issues by bioethicists and people responsible for ethics reviews and compliance with ethics regulations. The tangled relation between ethical problems and solutions invites a comparison to Rittel and Webber's "wicked problems." Official ethics' attempts to produce universal solutions often make ethics problems even more wickedly intractable. Ethics on the ground is in part a reaction to this intractability. Copyright © 2012 Elsevier Ltd. All rights reserved.

  19. Agriculture’s Ethical Horizon, book review

    Science.gov (United States)

    Roughly 6.5 billion people inhabit the earth, but over 1 billion people regularly go hungry. This food shortfall poses an ethical dilemma for agriculture, and Agriculture's Ethical Horizon grapples with this dilemma. It argues that agricultural productivity has been the quintessential value of agr...

  20. A Systematic Review of Ebola Treatment Trials to Assess the Extent to Which They Adhere to Ethical Guidelines.

    Directory of Open Access Journals (Sweden)

    Thomas Richardson

    Full Text Available Objective: To determine to what extent each trial met criteria specified in three research frameworks for ethical trial conduct. Design: Systematic review and narrative analysis.Data sources: MEDBASE and EMBASE databases were searched using a specific search strategy. The Cochrane database for systematic reviews, the PROSPERO database and trial registries were examined. A grey literature search and citation search were also carried out. Eligibility criteria for selecting studies: Studies were included where the intervention was being used to treat Ebola in human subjects regardless of study design, comparator or outcome measured. Studies were eligible if they had taken place after the 21st March 2014. Unpublished as well as published studies were included. Included studies: Sixteen studies were included in the data synthesis. Data was extracted on study characteristics as well as any information relating to ten ethical areas of interest specified in the three research frameworks for ethical trial conduct and an additional criterion of whether the study received ethics approval from a research ethics committee. Synthesis of results: Eight studies were judged to fully comply with all eleven criteria. The other eight studies all had at least one criteria where there was not enough information available to draw any conclusions. In two studies there were ethical concerns regarding the information provided in relation to at least one ethical criteria. Description of the effect: One study did not receive ethical approval as the authors argued that treating approximately one hundred patients consecutively for compassionate reasons did not constitute a clinical trial. Furthermore, after the patients were treated, physicians in Sierra Leone did not release reports of treatment results and so study conclusions had to be made based on unpublished observations. In another study the risk-benefit ratio of the trial drug does not appear to be favourable and the

  1. 76 FR 77825 - Human Studies Review Board; Notification of a Public Teleconference

    Science.gov (United States)

    2011-12-14

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0953; FRL-9506-6] Human Studies Review Board; Notification of a Public Teleconference AGENCY: Environmental Protection Agency. ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public teleconference of the HSRB to discuss its draft...

  2. 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.

  3. The ethical commitment of independent directors in different contexts of investor protection

    Directory of Open Access Journals (Sweden)

    Isabel María García-Sánchez

    2015-04-01

    Full Text Available The purpose of this study is to compare, for countries with different legal environments, the degree to which boards of directors may improve corporate ethical behaviour by designing codes of ethics. These codes address issues such as a company's responsibility regarding the quality of its products and services, compliance with laws and regulations, conflicts of interest, corruption and fraud, and protection of the natural environment. Using a sample of firms from 12 countries, we obtain evidence that a greater presence of independent directors on the board leads to the existence of more complex codes of ethics. Moreover, there are significant differences between countries with high levels and countries with low levels of investor protection as regards the effectiveness of independent directors in constraining unethical behaviour by managers.

  4. A missing ethical competency? A review of critical reflection in health promotion.

    Science.gov (United States)

    Tretheway, Rebecca; Taylor, Jane; O'Hara, Lily; Percival, Nikki

    2015-12-01

    There is increasing emphasis in the health promotion literature on the ethical imperative for the profession to move towards critical practice. A key challenge for health promotion is that critical practice appears both under-developed and under-practiced. This is evident in the omission of critical reflection from Australian and international competencies for health promotion practitioners. A narrative literature review was undertaken to explore the current use of critical reflection in health promotion. Critical reflection models relevant to health promotion were identified and critiqued. There was a dearth of literature on critical reflection within health promotion, despite recognition of its potential to support critical practice. The discipline of critical social work provided literature on the use, effect and outcome of critical reflection in practice. The interdisciplinary critical reflection model was identified as the model most applicable to health promotion. Underpinned by critical theory, this model emphasises both critical and ethical practice. Critical reflection is a core competency for health promotion practitioners to address the ethical imperative to move towards critical practice. There is a need to explore the application of a critical reflection model in health promotion to determine how it may support critical and ethical practice. So what? If health promotion is to meet its ethical responsibilities, then critical reflection needs to be articulated as a core health promotion competency and a model for its application in health promotion developed.

  5. Teaching for Ethical Reasoning

    Science.gov (United States)

    Sternberg, Robert J.

    2012-01-01

    This article argues for the importance of teaching for ethical reasoning. Much of our teaching is in vain if it is not applied to life in an ethical manner. The article reviews lapses in ethical reasoning and the great costs they have had for society. It proposes that ethical reasoning can be taught across the curriculum. It presents an eight-step…

  6. Review of Instructional Approaches in Ethics Education.

    Science.gov (United States)

    Mulhearn, Tyler J; Steele, Logan M; Watts, Logan L; Medeiros, Kelsey E; Mumford, Michael D; Connelly, Shane

    2017-06-01

    Increased investment in ethics education has prompted a variety of instructional objectives and frameworks. Yet, no systematic procedure to classify these varying instructional approaches has been attempted. In the present study, a quantitative clustering procedure was conducted to derive a typology of instruction in ethics education. In total, 330 ethics training programs were included in the cluster analysis. The training programs were appraised with respect to four instructional categories including instructional content, processes, delivery methods, and activities. Eight instructional approaches were identified through this clustering procedure, and these instructional approaches showed different levels of effectiveness. Instructional effectiveness was assessed based on one of nine commonly used ethics criteria. With respect to specific training types, Professional Decision Processes Training (d = 0.50) and Field-Specific Compliance Training (d = 0.46) appear to be viable approaches to ethics training based on Cohen's d effect size estimates. By contrast, two commonly used approaches, General Discussion Training (d = 0.31) and Norm Adherence Training (d = 0.37), were found to be considerably less effective. The implications for instruction in ethics training are discussed.

  7. 12 CFR 264.101 - Cross-reference to employees' ethical conduct standards and financial disclosure regulations.

    Science.gov (United States)

    2010-01-01

    ... 12 Banks and Banking 3 2010-01-01 2010-01-01 false Cross-reference to employees' ethical conduct... § 264.101 Cross-reference to employees' ethical conduct standards and financial disclosure regulations... branch-wide standards of ethical conduct at 5 CFR part 2635 and the Board's regulation at 5 CFR part 6801...

  8. Ethics Education in Accounting Curricula: Does It Influence Recruiters' Hiring Decisions of Entry-Level Accountants?

    Science.gov (United States)

    Breaux, Kevin; Chiasson, Michael; Mauldin, Shawn; Whitney, Teresa

    2010-01-01

    Recently, the National Association of State Boards of Accountancy (NASBA) has focused its attention on mandating specific ethics coursework within the 150-hr requirement for eligibility to sit for the uniform CPA examination. This push for ethics education heightened attention toward ethics in the accounting curriculum and is the basis for the…

  9. NAEYC Code of Ethical Conduct. Revised = Codigo de Conducta Etica. Revisada

    Science.gov (United States)

    National Association of Elementary School Principals (NAESP), 2005

    2005-01-01

    This document presents a code of ethics for early childhood educators that offers guidelines for responsible behavior and sets forth a common basis for resolving ethical dilemmas encountered in early education. It represents the English and Spanish versions of the revised code. Its contents were approved by the NAEYC Governing Board in April 2005…

  10. The Effect of Computer Automation on Institutional Review Board (IRB) Office Efficiency

    Science.gov (United States)

    Oder, Karl; Pittman, Stephanie

    2015-01-01

    Companies purchase computer systems to make their processes more efficient through automation. Some academic medical centers (AMC) have purchased computer systems for their institutional review boards (IRB) to increase efficiency and compliance with regulations. IRB computer systems are expensive to purchase, deploy, and maintain. An AMC should…

  11. 75 FR 54445 - Senior Executive Service; Financial Management Service Performance Review Board (PRB)

    Science.gov (United States)

    2010-09-07

    ..., Management (Chief Financial Officer). Alfred J. Kopec, Assistant Commissioner, Business Architecture. Sheryl... DEPARTMENT OF THE TREASURY Fiscal Service Senior Executive Service; Financial Management Service Performance Review Board (PRB) AGENCY: Financial Management Service, Fiscal Service, Treasury. ACTION: Notice...

  12. The use of care robots in aged care: A systematic review of argument-based ethics literature.

    Science.gov (United States)

    Vandemeulebroucke, Tijs; Dierckx de Casterlé, Bernadette; Gastmans, Chris

    2018-01-01

    As care robots become more commonplace in aged-care settings, the ethical debate on their use becomes increasingly important. Our objective was to examine the ethical arguments and underlying concepts used in the ethical debate on care robot use in aged care. We conducted a systematic literature search for argument-based ethics publications focusing on care robot use in aged-care practices. We used an innovative methodology that consisted of three steps: (a) identifying conceptual-ethical questions, (b) conducting a literature search, and (c) identifying, describing and analyzing the ethical arguments in connection with the conceptual-ethical questions. Twenty-eight appropriate publications were identified. All were published between 2002 and 2016. Four primary ethical approaches were distinguished: (a) a deontological, (b) a principlist, (c) an objective-list, and (d) a care-ethical. All approaches were equally represented across the articles, and all used similar concepts that grounded their diverse ethical arguments. A small group of publications could not be linked to an ethical approach. All included publications presented a strong ethical rationale based on fully elaborated normative arguments. Although the reviewed studies used similar grounding concepts, the studies' arguments were very diverse and sometimes diametrically opposed. Our analysis shows how one envisions care robot use in aged-care settings is influenced by how one views the traditional boundaries of the ethical landscape in aged care. We suggest that an ethical analysis of care robot use employs "democratic spaces," in which all stakeholders in aged care, especially care recipients, have a voice in the ethical debate. Copyright © 2017 Elsevier B.V. All rights reserved.

  13. Ethics: No Longer Optional.

    Science.gov (United States)

    Eveslage, Thomas; D'Angelo, Paul

    1994-01-01

    Suggests that publications advisors have sound, practical reasons for addressing ethical decision making. Presents a brief review of the Supreme Court's message in "Hazelwood." Surveys staffs and advisors of award-winning high school newspapers concerning ethical issues facing the student press. Finds that advisors believe ethics to be…

  14. 77 FR 69814 - National Assessment Governing Board; Meeting

    Science.gov (United States)

    2012-11-21

    ... procurement plans and independent government cost estimates from the National Center for Education Statistics... procurement and contract negotiations for NAEP. Discussion of this information would be likely to.... to 4:15 p.m., Board members will receive their annual ethics briefing from the Office of General...

  15. Bench-to-bedside review: human subjects research--are more standards needed?

    Science.gov (United States)

    Huang, David T; Hadian, Mehrnaz

    2006-01-01

    There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine.

  16. A comparison of ethical issues in nursing practice across nursing units.

    Science.gov (United States)

    Park, Mihyun; Jeon, Sang Hee; Hong, Hyun-Ja; Cho, Sung-Hyun

    2014-08-01

    The complexity and variety of ethical issues in nursing is always increasing, and those issues lead to special concerns for nurses because they have critical impacts on nursing practice. The purpose of this study was to gather comprehensive information about ethical issues in nursing practice, comparing the issues in different types of nursing units including general units, oncology units, intensive care units, operating rooms, and outpatient departments. The study used a descriptive research design. Ethics/human rights issues encountered by nurses in their daily nursing practice were identified by using the Ethical Issues Scale. The study sample included 993 staff nurses working in a university hospital in South Korea. This study was approved by the University Institutional Review Board. Completed questionnaires were returned sealed with signed informed consent. The most frequently and disturbingly encountered issues across nursing units were "conflicts in the nurse-physician relationship," "providing care with a possible risk to your health," and "staffing patterns that limit patient access to nursing care." The findings of this study showed that nurses from different nursing units experienced differences in the types or frequency of ethical issues. In particular, intensive care units had the greatest means of all the units in all three component scales including end-of-life treatment issues, patient care issues, and human rights issues. Nurses experienced various ethical challenges in their daily practice. Of the ethical issues, some were distinctively and frequently experienced by nurses in a specific unit. This study suggested that identifying and understanding specific ethical issues faced by nurses in their own areas may be an effective educational approach to motivate nurses and to facilitate nurses' reflection on their experiences. © The Author(s) 2014.

  17. 75 FR 49938 - Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

    Science.gov (United States)

    2010-08-16

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

  18. Taking the prudent path. Best practices for not-for-profit boards.

    Science.gov (United States)

    Peregrine, Michael W; Schwartz, James R

    2003-01-01

    A direct outgrowth of the Sarbanes-Oxley Act, best practices in corporate governance strengthen board independence, provide a framework for ethical decision-making and enhance compliance with state and national regulations.

  19. Effect of ventilation rate and board loading on formaldehyde concentration : a critical review of the literature

    Science.gov (United States)

    George E. Myers

    1984-01-01

    A critical literature review has been carried out on the influence of ventilation rate (N, hr.-1) and board loading (L, m2/m3) on steady state formaldehyde concentrations (Cs, ppm) resulting from particleboard and plywood emissions. Large differences exist among boards in the extent to which their formaldehyde concentrations change with N or L in laboratory chambers....

  20. 76 FR 51364 - Notification of a Public Teleconference of the Science Advisory Board Panel for the Review of the...

    Science.gov (United States)

    2011-08-18

    ... Science Advisory Board Panel for the Review of the Great Lakes Restoration Initiative Action Plan AGENCY... Agency) Science Advisory Board (SAB) Staff Office announces a public teleconference of the SAB Panel to... information concerning the EPA Science Advisory Board can be found at the EPA SAB Web site at http://www.epa...

  1. ECONOMICS ETHICS IN THE FATWA OF ISLAMIC ECONOMICS

    Directory of Open Access Journals (Sweden)

    Muhammad Maksum

    2015-06-01

    Full Text Available The fatwa by the National Sharia Board (Dewan Syariah Nasional/DSN of Indonesian Ulema Council (Majlis Ulama Indonesia/MUI and The Sharia Advisory Council of Central Bank of Malaysia/Bank Negara Malaysia (BNM on Islamic economics is dominated by its ethical aspects. The prohibition of riba (interest, for instance, is an Islamic ethic which is mostly set in both institutions. In this case, the Legal consideration contains more ethics than fatwa verdicts. The ethics in the legal consideration is commonly based on the basic ethical principles of The Noble Qur'an, the hadith and the Islamic jurisprudence. In the meantime, the ethics for the object of contract in DSN is mentioned more in the fatwa verdict than in their legal consideration while the ethics for contract performer is equally found in both areas. This thesis is discovered by reading the DSN's fatwa from 2000 t0 2010 and the MPA's fatwa from 1997 to 2010. Once identified, the ethics in both institutions is classified into a particular category. As the result, this research generates a great implication on the dominant aspect of Islamic ethics in its legal formal.

  2. Factors Associated with Review Board Dispositions following Re-hospitalization among Discharged Persons found Not Criminally Responsible.

    Science.gov (United States)

    Wilson, Catherine M; Nicholls, Tonia L; Charette, Yanick; Seto, Michael C; Crocker, Anne G

    2016-03-01

    In the Canadian forensic mental health system, a person found Not Criminally Responsible on account of Mental Disorder (NCRMD) and given a conditional discharge returns to the community while remaining under the jurisdiction of a provincial/territorial Review Board. However, the individual can be re-hospitalized while on conditional discharge, for reasons such as substance use, violation of conditions, or violence. We investigated whether being re-hospitalized has an impact on the factors associated with the subsequent Review Board disposition. Persons found NCRMD from the three largest Canadian provinces who were conditionally discharged at least once during the observation period were included in the sample (N = 1,367). These individuals were involved in 2,920 disposition hearings; nearly one-third of patients (30%) were re-hospitalized after having been conditionally discharged by the Review Board. The factors examined included the scales of the Historical Clinical Risk Management-20 and salient behavior that occurred since the previous hearing, such as substance use or violence. The greater presence of clinical items resulted in a greater likelihood of a hospital detention decision at the next hearing. The effect was larger for the re-hospitalized group than for the group who successfully remained in the community since the last hearing. The results suggest that dynamic factors, specifically indicators of mental health, are heavily weighted by the Review Boards, consistent with the literature on imminent risk and in line with the NCRMD legislation. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

  3. Ethics case reflection sessions: Enablers and barriers.

    Science.gov (United States)

    Bartholdson, Cecilia; Molewijk, Bert; Lützén, Kim; Blomgren, Klas; Pergert, Pernilla

    2018-03-01

    In previous research on ethics case reflection (ECR) sessions about specific cases, healthcare professionals in childhood cancer care were clarifying their perspectives on the ethical issue to resolve their main concern of consolidating care. When perspectives were clarified, consequences in the team included 'increased understanding', 'group strengthening' and 'decision grounding'. Additional analysis of the data was needed on conditions that could contribute to the quality of ECR sessions. The aim of this study was to explore conditions for clarifying perspectives during ECR sessions. Data were collected from observations and interviews and the results emerged from an inductive analysis using grounded theory. Participants and research context: Six observations during ECR sessions and 10 interviews were performed with healthcare professionals working in childhood cancer care and advanced paediatric homecare. Ethical considerations: The study was approved by a regional ethical review board. Participants were informed about their voluntary involvement and that they could withdraw their participation without explaining why. Two categories emerged: organizational enablers and barriers and team-related enablers and barriers. Organizational enablers and barriers included the following sub-categories: the timing of the ECR session, the structure during the ECR session and the climate during the ECR session. Sub-categories to team-related enablers and barriers were identified as space for inter-professional perspectives, varying levels of ethical skills and space for the patient's and the family's perspectives. Space for inter-professional perspectives included the dominance of a particular perspective that can result from hierarchical positions. The medical perspective is relevant for understanding the child's situation but should not dominate the ethical reflection. Conditions for ECR sessions have been explored and the new knowledge can be used when training

  4. A study of promotional advertisements of drugs in a medical journal: an ethics perspective.

    Science.gov (United States)

    Nath, Sarmila; Bhowmick, Subhrojyoti; Dutta, Trayambak; Chowrasia, V R; Bhattacharya, Shipra; Chatterjee, R N; Sarkar, Manjula; Ram, A K; Mukherjee, P K

    2014-01-01

    The study assessed 54 advertisements of 145 different drugs, published over one year (from December 2011 to November 2012) in an Indian medical journal, circulated widely mainly among general practitioners (GPs). The ethical guidelines of the World Health Organization (WHO) and Organisation of Pharmaceutical Producers of India (OPPI) for medicinal drug promotion were applied. The brand name was mentioned in all advertisements (100% compliance both with the WHO and OPPI criteria) and the names of the active ingredients were also mentioned in 128 (90.14%) advertisements. However, major adverse drug reactions were mentioned in only two advertisements (1.37%); precautions, contraindications and warnings in only two (1.37%); and major interactions in only one (0.68%). Only three advertisements (2.06%) were well substantiated with references. To ensure the ethical promotionof drugs among GPs, journals must introduce compulsory review and appraisal of promotional advertisements by a dedicated review board, including at least one member trained in pharmacology and one representative from the medical division of a pharmaceutical company.

  5. Sexuality in institutionalized elderly persons: a systematic review of argument-based ethics literature.

    Science.gov (United States)

    Mahieu, Lieslot; Gastmans, Chris

    2012-03-01

    Admission to a nursing home might challenge the way in which individuals experience their own sexuality, but it does not automatically diminish their need and desire for sexual fulfillment. Despite the fact that sexuality proves to be an intrinsic part of human existence, the sexual expression of geriatric residents remains a sensitive subject for many caregivers and family members. It evokes a variety of ethical issues and concerns, especially when dementia patients are involved. The overall objective of this review was to examine the ethical arguments and concepts about the debate on sexuality within a nursing home environment. We conducted a systematic search for argument-based ethics literature focusing on sexuality in institutionalized elderly people. Twenty-five appropriate studies were identified. A thematic analysis of the included literature led us to distinguish two major groups of ethical arguments: (i) principles and (ii) care. Ethics arguments on sexuality in institutionalized elderly are particularly guided by the principle of respect for autonomy and the concomitant notion of informed consent. Arguments related to care were also apparent within the research literature although they received considerably less attention than the arguments related to the principles of respect for autonomy, beneficence, nonmaleficence and justice. The lack of clarity in the conceptualization of the arguments referred to in the research literature indicates that there is a pressing need for a better defined, more fundamental philosophical-ethical analysis of the values at stake.

  6. The ethical desirability of moral bioenhancement: a review of reasons

    Science.gov (United States)

    2014-01-01

    Background The debate on the ethical aspects of moral bioenhancement focuses on the desirability of using biomedical as opposed to traditional means to achieve moral betterment. The aim of this paper is to systematically review the ethical reasons presented in the literature for and against moral bioenhancement. Discussion A review was performed and resulted in the inclusion of 85 articles. We classified the arguments used in those articles in the following six clusters: (1) why we (don’t) need moral bioenhancement, (2) it will (not) be possible to reach consensus on what moral bioenhancement should involve, (3) the feasibility of moral bioenhancement and the status of current scientific research, (4) means and processes of arriving at moral improvement matter ethically, (5) arguments related to the freedom, identity and autonomy of the individual, and (6) arguments related to social/group effects and dynamics. We discuss each argument separately, and assess the debate as a whole. First, there is little discussion on what distinguishes moral bioenhancement from treatment of pathological deficiencies in morality. Furthermore, remarkably little attention has been paid so far to the safety, risks and side-effects of moral enhancement, including the risk of identity changes. Finally, many authors overestimate the scientific as well as the practical feasibility of the interventions they discuss, rendering the debate too speculative. Summary Based on our discussion of the arguments used in the debate on moral enhancement, and our assessment of this debate, we advocate a shift in focus. Instead of speculating about non-realistic hypothetical scenarios such as the genetic engineering of morality, or morally enhancing ‘the whole of humanity’, we call for a more focused debate on realistic options of biomedical treatment of moral pathologies and the concrete moral questions these treatments raise. PMID:25227512

  7. Steps to strengthen ethics in organizations: research findings, ethics placebos, and what works.

    Science.gov (United States)

    Pope, Kenneth S

    2015-01-01

    Research shows that many organizations overlook needs and opportunities to strengthen ethics. Barriers can make it hard to see the need for stronger ethics and even harder to take effective action. These barriers include the organization's misleading use of language, misuse of an ethics code, culture of silence, strategies of justification, institutional betrayal, and ethical fallacies. Ethics placebos tend to take the place of steps to see, solve, and prevent problems. This article reviews relevant research and specific steps that create change.

  8. 78 FR 12422 - Health Services Research and Development Service Scientific Merit Review Board, Notice of Meeting

    Science.gov (United States)

    2013-02-22

    ... DEPARTMENT OF VETERANS AFFAIRS Health Services Research and Development Service Scientific Merit... nursing research. Applications are reviewed for scientific and technical merit, mission relevance, and the... Program Manager, Scientific Merit Review Board, Department of Veterans Affairs, Health Services Research...

  9. Bench-to-bedside review: Human subjects research – are more standards needed?

    Science.gov (United States)

    Huang, David T; Hadian, Mehrnaz

    2006-01-01

    There are many controversial issues surrounding ethics in study design and conduct of human subjects research. In this review we briefly touch on the origin of ethics in clinical research and how the current regulations and standards came into practice. We then discuss current controversies regarding informed consent, conflicts of interest, institutional review boards, and other relevant issues such as innovative procedures and quality improvement projects. The question of whether we need more standards is a very important yet challenging one to which there is no simple answer. We address this question by reviewing and commenting on relevant literature. We conclude that what is needed are not more standards per se, but rather refinement and uniformity of current standards, and their interpretation and application both to protect human subjects and to advance medicine. PMID:17184560

  10. 78 FR 6854 - Health Services Research and Development Service Scientific Merit Review Board; Notice of Meeting

    Science.gov (United States)

    2013-01-31

    ... DEPARTMENT OF VETERANS AFFAIRS Health Services Research and Development Service Scientific Merit... Research and Development Service Scientific Merit Review Board will meet on February 13-14, 2013, at the... research. Applications are reviewed for scientific and technical merit. Recommendations regarding funding...

  11. Ethical Concerns of and Risk Mitigation Strategies for Crowdsourcing Contests and Innovation Challenges: Scoping Review

    Science.gov (United States)

    Pan, Stephen W; Mathews, Allison; Stein, Gabriella; Bayus, Barry; Rennie, Stuart

    2018-01-01

    Background Crowdsourcing contests (also called innovation challenges, innovation contests, and inducement prize contests) can be used to solicit multisectoral feedback on health programs and design public health campaigns. They consist of organizing a steering committee, soliciting contributions, engaging the community, judging contributions, recognizing a subset of contributors, and sharing with the community. Objective This scoping review describes crowdsourcing contests by stage, examines ethical problems at each stage, and proposes potential ways of mitigating risk. Methods Our analysis was anchored in the specific example of a crowdsourcing contest that our team organized to solicit videos promoting condom use in China. The purpose of this contest was to create compelling 1-min videos to promote condom use. We used a scoping review to examine the existing ethical literature on crowdsourcing to help identify and frame ethical concerns at each stage. Results Crowdsourcing has a group of individuals solve a problem and then share the solution with the public. Crowdsourcing contests provide an opportunity for community engagement at each stage: organizing, soliciting, promoting, judging, recognizing, and sharing. Crowdsourcing poses several ethical concerns: organizing—potential for excluding community voices; soliciting—potential for overly narrow participation; promoting—potential for divulging confidential information; judging—potential for biased evaluation; recognizing—potential for insufficient recognition of the finalist; and sharing—potential for the solution to not be implemented or widely disseminated. Conclusions Crowdsourcing contests can be effective and engaging public health tools but also introduce potential ethical problems. We present methods for the responsible conduct of crowdsourcing contests. PMID:29523500

  12. Ethical principles for project collaboration between academic professionals or institutions and the biomedical industry

    Directory of Open Access Journals (Sweden)

    Riis P

    2012-04-01

    Full Text Available Povl Riis Age Forum, State Board for Research and Age Policies, Odense, DenmarkAbstract: Ethics in biomedical research cannot be defined by etymology, and need a semantic definition based on national and contemporary values. In a Nordic cultural and historic context, key values are solidarity with one's fellow man, equality, truth, justice, responsibility, freedom, and professionalism. In contemporary medical research, such ethics are further subgrouped into research ethics, researcher ethics, societal ethics, and distributive ethics. Lately, public and academic debates have addressed the necessary strengthening of the ethical concerns and interests of patients and society. Despite considerable progress, common ethical definitions and control systems still lack uniformity or indeed do not exist. Among the cooperative partners involved, the pharmaceutical industry have preserved an important role. The same is true for the overall judgments reflected by the European Forum for Good Clinical Practice, leading peer-reviewed journals, the Nuffield Council on Bioethics for developing nations, and the latest global initiative, the Singapore Statement on Research Integrity. To help both institutions and countries, it will be valuable to include the following information in academia–industry protocols before starting a project: international authorship names; fixed agendas and time schedules for project meetings; chairperson shifts, meeting reports, and project plan changes; future author memberships; equal blinding and data distribution from disciplinary groups; an equal plan for exchange of project manuscripts at the proofing stage; contractual descriptions of all procedures, disagreements, publishing rights, prevention, and controls for suspected dishonesty; and a detailed description of who is doing what in the working process.Keywords: ethics, collaboration, academia, biomedical industry

  13. Ethical framework of assistive devices: review and reflection.

    Science.gov (United States)

    Mansouri, Nazanin; Goher, Khaled; Hosseini, Seyed Ebrahim

    2017-01-01

    The population of ageing is growing significantly over the world, and there is an emerging demand for better healthcare services and more care centres. Innovations of Information and Communication Technology has resulted in development of various types of assistive robots to fulfil elderly's needs and independency, whilst carrying out daily routine tasks. This makes it vital to have a clear understanding of elderly's needs and expectations from assistive robots. This paper addresses current ethical issues to understand elderly's prime needs. Also, we consider other general ethics with the purpose of applying these theories to form a proper ethics framework. In the ethics framework, the ethical concerns of senior citizens will be prioritized to satisfy elderly's needs and also to diminish related expenses to healthcare services.

  14. 78 FR 63380 - Farm Credit Administration Board Policy Statements

    Science.gov (United States)

    2013-10-24

    ... Business of the Farm Credit Administration Board FCA-PS-65 Release of Consolidated Reporting System... FCS Building Association Management Operations Policies and Practices FCA-PS-71 Disaster Relief... the Members of Farm Credit System Institutions FCA-PS-81 Ethics, Independence, Arm's-Length Role, Ex...

  15. 49 CFR 1103.11 - Standards of ethical conduct in courts of the United States to be observed.

    Science.gov (United States)

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Standards of ethical conduct in courts of the... PRACTITIONERS Canons of Ethics The Practitioner's Duties and Responsibilities Toward the Board § 1103.11 Standards of ethical conduct in courts of the United States to be observed. These canons further the purpose...

  16. 76 FR 52997 - Public Company Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for...

    Science.gov (United States)

    2011-08-24

    ... Accounting Oversight Board; Order Approving Proposed Board Funding Final Rules for Allocation of the Board's... August 18, 2011. I. Introduction On June 21, 2011, the Public Company Accounting Oversight Board (the... public accounting firm, in amounts that are sufficient to cover the costs of processing and reviewing...

  17. Navigating the Process of Ethical Approval: A methodological note

    Directory of Open Access Journals (Sweden)

    Eileen Carey, RNID, BSc. (hons, MSc.

    2010-12-01

    Full Text Available Classic grounded theory (CGT methodology is a general methodology whereby the researcher aims to develop an emergent conceptual theory from empirical data collected by the researcher during the research study. Gaining ethical approval from relevant ethics committees to access such data is the starting point for processing a CGT study. The adoption of the Universal Declaration on Bioethics and Human Rights (UNESCO, 2005 is an indication of global consensus on the importance of research ethics. There is, however, a wide variation of health research systems across countries and disciplines (Hearnshaw 2004. Institutional Research Boards (IRB or Research Ethics Committees (REC have been established in many countries to regulate ethical research ensuring that researchers agree to, and adhere to, specific ethical and methodological conditions prior to ethical approval being granted. Interestingly, both the processes and outcomes through which the methodological aspects pertinent to CGT studies are agreed between the researcher and ethics committee remain largely ambiguous and vague. Therefore, meeting the requirements for ethical approval from ethics committees, while enlisting the CGT methodology as a chosen research approach, can be daunting for novice researchers embarking upon their first CGT study.

  18. 78 FR 18978 - Human Studies Review Board; Notification of a Public Webinar/Teleconference

    Science.gov (United States)

    2013-03-28

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2013-0115; FRL 9794-8] Human Studies Review Board; Notification of a Public Webinar/ Teleconference AGENCY: U. S. Environmental Protection Agency (EPA). ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public Webinar/teleconference of the...

  19. Action Researchers Encountering Ethical Review: A Literature Synthesis on Challenges and Strategies

    Science.gov (United States)

    Fouché, Christa B.; Chubb, Laura A.

    2017-01-01

    Action research (AR) comprises a diverse family of methodologies. Common amongst most types of AR are both an emergent design--leading to action or change--and participation or community involvement. While this type of research has expanded considerably since the early 2000s, the criteria used for ethical review have apparently been slow to adapt…

  20. 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.

  1. IRSN Code of Ethics and Professional Conduct. Annex VII [TSO Mission Statement and Code of Ethics

    International Nuclear Information System (INIS)

    2018-01-01

    IRSN has adopted, in 2013, a Code of Ethics and Professional Conduct, the contents of which are summarized. As a preamble, it is indicated that the Code, which was adopted in 2013 by the Ethics Commission of IRSN and the Board of IRSN, complies with relevant constitutional and legal requirements. The introduction to the Code presents the role and missions of IRSN in the French system, as well as the various conditions and constraints that frame its action, in particular with respect to ethical issues. It states that the Code sets principles and establishes guidance for addressing these constraints and resolving conflicts that may arise, thus constituting references for the Institute and its staff, and helping IRSN’s partners in their interaction with the Institute. The stipulations of the Code are organized in four articles, reproduced and translated.

  2. Ethical and policy issues in cluster randomized trials: rationale and design of a mixed methods research study

    Directory of Open Access Journals (Sweden)

    Chaudhry Shazia H

    2009-07-01

    Full Text Available Abstract Background Cluster randomized trials are an increasingly important methodological tool in health research. In cluster randomized trials, intact social units or groups of individuals, such as medical practices, schools, or entire communities – rather than individual themselves – are randomly allocated to intervention or control conditions, while outcomes are then observed on individual cluster members. The substantial methodological differences between cluster randomized trials and conventional randomized trials pose serious challenges to the current conceptual framework for research ethics. The ethical implications of randomizing groups rather than individuals are not addressed in current research ethics guidelines, nor have they even been thoroughly explored. The main objectives of this research are to: (1 identify ethical issues arising in cluster trials and learn how they are currently being addressed; (2 understand how ethics reviews of cluster trials are carried out in different countries (Canada, the USA and the UK; (3 elicit the views and experiences of trial participants and cluster representatives; (4 develop well-grounded guidelines for the ethical conduct and review of cluster trials by conducting an extensive ethical analysis and organizing a consensus process; (5 disseminate the guidelines to researchers, research ethics boards (REBs, journal editors, and research funders. Methods We will use a mixed-methods (qualitative and quantitative approach incorporating both empirical and conceptual work. Empirical work will include a systematic review of a random sample of published trials, a survey and in-depth interviews with trialists, a survey of REBs, and in-depth interviews and focus group discussions with trial participants and gatekeepers. The empirical work will inform the concurrent ethical analysis which will lead to a guidance document laying out principles, policy options, and rationale for proposed guidelines. An

  3. Intelligence Ethics:

    DEFF Research Database (Denmark)

    Rønn, Kira Vrist

    2016-01-01

    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.......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...

  4. 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).

  5. A systematic literature review on the ethics of palliative sedation: an update (2016).

    Science.gov (United States)

    Henry, Blair

    2016-09-01

    Palliative sedation has been the subject of intensive debate since its first appearance in 1990. In a 2010 review of palliative sedation, the following areas were identified as lacking in consensus: inconsistent terminology, its use in nonphysical suffering, the ongoing experience of distress, and concern that the practice of palliative sedation may hasten death. This review looks at the literature over the past 6 years and provides an update on these outstanding concerns. Good clinical guidelines and policies are still required to address issues of emotional distress and waylay concerns that palliative sedation hastens death. The empirical evidence suggests some movement toward consensus on the practice of palliative sedation. However, a continued need exists for evidence-informed practice guidelines, education, and research to support the ethical practice of palliative sedation at the end of life. Until that time, clinicians are advised to adopt a framework or guideline that has been expert driven to ensure consistent and ethical use of palliative sedation at the end of life.

  6. Ethics Education for Professionals in Japan: A Critical Review

    Science.gov (United States)

    Maruyama, Yasushi; Ueno, Tetsu

    2010-01-01

    Ethics education for professionals has become popular in Japan over the last two decades. Many professional schools now require students to take an applied ethics or professional ethics course. In contrast, very few courses of professional ethics for teaching exist or have been taught in Japan. In order to obtain suggestions for teacher education,…

  7. 76 FR 25686 - Human Studies Review Board (HSRB); Notification of a Public Teleconference

    Science.gov (United States)

    2011-05-05

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0418; FRL-9302-4] Human Studies Review Board (HSRB); Notification of a Public Teleconference AGENCY: Environmental Protection Agency (EPA). ACTION...) announces a public teleconference of the HSRB to discuss its draft report from the April 13-14, 2011 HSRB...

  8. 77 FR 15099 - Human Studies Review Board; Notification of a Public Webinar/Teleconference

    Science.gov (United States)

    2012-03-14

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0175; FRL-9647-2] Human Studies Review Board; Notification of a Public Webinar/ Teleconference AGENCY: U. S. Environmental Protection Agency. ACTION: Notice. SUMMARY: The EPA Office of the Science Advisor announces a public Webinar/teleconference of the HSRB to...

  9. Ethical challenges with welfare technology: a review of the literature.

    Science.gov (United States)

    Hofmann, Bjørn

    2013-06-01

    Demographical changes in high income counties will increase the need of health care services but reduce the number of people to provide them. Welfare technology is launched as an important measure to meet this challenge. As with all types of technologies we must explore its ethical challenges. A literature review reveals that welfare technology is a generic term for a heterogeneous group of technologies and there are few studies documenting their efficacy, effectiveness and efficiency. Many kinds of welfare technology break with the traditional organization of health care. It introduces technology in new areas, such as in private homes, and it provides new functions, e.g. offering social stimuli and entertainment. At the same time welfare technology is developed for groups that traditionally have not been extensive technology users. This raises a series of ethical questions with regard to the development and use of welfare technologies, which are presented in this review. The main challenges identified are: (1) Alienation when advanced technology is used at home, (2) conflicting goals, as welfare technologies have many stakeholders with several ends, (3) respecting confidentiality and privacy when third-party actors are involved, (4) guaranteeing equal access and just distribution, and (5) handling conflicts between instrumental rationality and care in terms of respecting dignity and vulnerability. Addressing these issues is important for developing and implementing welfare technologies in a morally acceptable manner.

  10. Ethical issues in autologous stem cell transplantation (ASCT) in advanced breast cancer: a systematic literature review.

    Science.gov (United States)

    Droste, Sigrid; Herrmann-Frank, Annegret; Scheibler, Fueloep; Krones, Tanja

    2011-04-15

    An effectiveness assessment on ASCT in locally advanced and metastatic breast cancer identified serious ethical issues associated with this intervention. Our objective was to systematically review these aspects by means of a literature analysis. We chose the reflexive Socratic approach as the review method using Hofmann's question list, conducted a comprehensive literature search in biomedical, psychological and ethics bibliographic databases and screened the resulting hits in a 2-step selection process. Relevant arguments were assembled from the included articles, and were assessed and assigned to the question list. Hofmann's questions were addressed by synthesizing these arguments. Of the identified 879 documents 102 included arguments related to one or more questions from Hofmann's question list. The most important ethical issues were the implementation of ASCT in clinical practice on the basis of phase-II trials in the 1990s and the publication of falsified data in the first randomized controlled trials (Bezwoda fraud), which caused significant negative effects on recruiting patients for further clinical trials and the doctor-patient relationship. Recent meta-analyses report a marginal effect in prolonging disease-free survival, accompanied by severe harms, including death. ASCT in breast cancer remains a stigmatized technology. Reported health-related-quality-of-life data are often at high risk of bias in favor of the survivors. Furthermore little attention has been paid to those patients who were dying. The questions were addressed in different degrees of completeness. All arguments were assignable to the questions. The central ethical dimensions of ASCT could be discussed by reviewing the published literature.

  11. Everyday Ethics: Reflections on Practice

    Science.gov (United States)

    Rossman, Gretchen B.; Rallis, Sharon F.

    2010-01-01

    This introductory article frames the contributions for this issue on everyday ethics--moments that demand moral considerations and ethical choices that researchers encounter. We discuss concerns raised within the research community about the tendency to observe merely obligatory ethical procedures as outlined in Human Subjects Review regulations.…

  12. 48 CFR 2903.602 - Exceptions.

    Science.gov (United States)

    2010-10-01

    ... a contract from the policy in FAR 3.601, after the Procurement Review Board and the agency ethics... agency ethics official, the Procurement Review Board, and written approval by the Assistant Secretary for... director of the cognizant program office to the HCA. In the procurement request, the director must describe...

  13. Instructional Vignettes in Publication and Journalism Ethics in Radiology Research: Assessment via a Survey of Radiology Trainees.

    Science.gov (United States)

    Rosenkrantz, Andrew B; Ginocchio, Luke A

    2016-07-01

    The aim of the present study was to assess the potential usefulness of written instructional vignettes relating to publication and journalism ethics in radiology via a survey of radiology trainees. A literature review was conducted to guide the development of vignettes, each describing a scenario relating to an ethical issue in research and publication, with subsequent commentary on the underlying ethical issue and potential approaches to its handling. Radiology trainees at a single institution were surveyed regarding the vignettes' perceived usefulness. A total of 21 vignettes were prepared, addressing institutional review board and human subjects protection, authorship issues, usage of previous work, manuscript review, and other miscellaneous topics. Of the solicited trainees, 24.7% (16/65) completed the survey. On average among the vignettes, 94.0% of the participants found the vignette helpful; 19.9 received prior formal instruction on the issue during medical training; 40.0% received prior informal guidance from a research mentor; and 42.0% indicated that the issue had arisen in their own or a peer's prior research experience. The most common previously experienced specific issue was authorship order (93.8%). Free-text responses were largely favorable regarding the value of the vignettes, although also indicated numerous challenges in properly handling the ethical issues: impact of hierarchy, pressure to publish, internal politics, reluctance to conduct sensitive conversations with colleagues, and variability in journal and professional society policies. Radiology trainees overall found the vignettes helpful, addressing commonly encountered topics for which formal and informal guidance were otherwise lacking. The vignettes are publicly available through the Association of University Radiologists (AUR) website and may foster greater insights by investigators into ethical aspects of the publication and journalism process, thus contributing to higher quality

  14. Evaluating the Intervention of an Ethics' Class in Students' Ethical Decision-Making: A Summative Review

    Science.gov (United States)

    Walker, Marquita

    2013-01-01

    This summative evaluation is the result of two years' of data reflecting the impact of an ethics class in terms of students' ethical decision-making. The research compares aggregate responses from scenario-based pre- and post-survey open-ended survey questions designed to measure changes in ethical decision-making by comparing students' cognitive…

  15. Factors influencing emergency nurses' ethical problems during the outbreak of MERS-CoV.

    Science.gov (United States)

    Choi, Jeong-Sil; Kim, Ji-Soo

    2018-05-01

    Whenever there has been a worldwide contagious disease outbreak, there have been reports of infection and death of healthcare workers. Particularly because emergency nurses have contact with patients on the front line, they experience ethical problems in nursing while struggling with infectious diseases in an unfavorable environment. The objective of this study was to explore emergency nurses' ethical problems and to identify factors influencing these problems during the outbreak of Middle East respiratory syndrome-coronavirus in Korea. For this cross-sectional study, a questionnaire survey was conducted with emergency nurses working in six hospitals selected through convenience sampling from the hospitals designated for Middle East respiratory syndrome-coronavirus patients in the capital area. Data were collected from 169 emergency nurses in Korea during August 2015. Ethical considerations: This research was approved by the Institutional Review Board of G University in Korea. The findings of this study suggest that during the Middle East respiratory syndrome-coronavirus outbreak, emergency nurses experienced ethical problems tied to a mind-set of avoiding patients. Three factors were found to influence emergency nurses' ethical problems (in order of influence): cognition of social stigmatization, level of agreement with infection control measures, and perceived risk. Through this study, we obtained information on emergency nurses' ethical problems during the Middle East respiratory syndrome-coronavirus outbreak and identified the factors that influence them. As found in this study, nurses' ethical problems were influenced most by cognitions of social stigmatization. Accordingly, to support nurses confidently care for people during future health disasters, it is most urgent to promote appropriate public consciousness that encourages healthcare workers.

  16. SMART Boards Rock

    Science.gov (United States)

    Giles, Rebecca M.; Shaw, Edward L.

    2011-01-01

    SMART Board is a technology that combines the functionality of a whiteboard, computer, and projector into a single system. The interactive nature of the SMART Board offers many practical uses for providing an introduction to or review of material, while the large work area invites collaboration through social interaction and communication. As a…

  17. Moral deliberation and nursing ethics cases: elements of a methodological proposal.

    Science.gov (United States)

    Schneider, Dulcinéia Ghizoni; Ramos, Flávia Regina Souza

    2012-11-01

    A qualitative study with an exploratory, descriptive and documentary design that was conducted with the objective of identifying the elements to constitute a method for the analysis of accusations of and proceedings for professional ethics infringements. The method is based on underlying elements identified inductively during analysis of professional ethics hearings judged by and filed in the archives of the Regional Nursing Board of Santa Catarina, Brazil, between 1999 and 2007. The strategies developed were based on the results of an analysis of the findings of fact (occurrences/infractions, causes and outcomes) contained in the records of 128 professional ethics hearings and on the structural elements (statements, rules and practices) identified in five example professional ethics cases. The strategies suggested for evaluating accusations of ethics infringements and the procedures involved in deliberating on ethics hearings constitute a generic proposal that will require adaptation to the context of specific professional ethics accusations.

  18. Translational ethics? The theory-practice gap in medical ethics.

    Science.gov (United States)

    Cribb, Alan

    2010-04-01

    Translational research is now a critically important current in academic medicine. Researchers in all health-related fields are being encouraged not only to demonstrate the potential benefits of their research but also to help identify the steps through which their research might be 'made practical'. This paper considers the prospects of a corresponding movement of 'translational ethics'. Some of the advantages and disadvantages of focusing upon the translation of ethical scholarship are reviewed. While emphasising the difficulties of crossing the gap between scholarship and practice, the paper concludes that a debate about the business of translation would be useful for medical ethics.

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

    Science.gov (United States)

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

    2016-01-01

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

  20. Internet Research Ethics and the Policy Gap for Ethical Practice in Online Research Settings

    Science.gov (United States)

    Warrell, Jacqueline G.; Jacobsen, Michele

    2014-01-01

    A growing number of education and social science researchers design and conduct online research. In this review, the Internet Research Ethics (IRE) policy gap in Canada is identified along with the range of stakeholders and groups that either have a role or have attempted to play a role in forming better ethics policy. Ethical issues that current…