Sample records for ethics review boards

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

    ERIC Educational Resources Information Center

    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…

  2. Is mandatory research ethics reviewing ethical?

    PubMed

    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.

  3. Spotlight on Ethics: Institutional Review Boards as Systemic Bullies

    ERIC Educational Resources Information Center

    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…

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

    PubMed

    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

  5. School Board Ethics: On Thin Ice?

    ERIC Educational Resources Information Center

    Natale, Jo Anna

    1990-01-01

    Cites cases of ethical violations, such as patronage and nepotism in hiring practices, in some school districts. Advises school board members to review their personal and professional ethics and to consider measures that will help guide decisions when ethical dilemmas arise. Formal ethics training is recommended for all educators. (MLF)

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

    PubMed Central

    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. Mock Institutional Review Board: Promoting Analytical and Reasoning Skills in Research Ethics.

    PubMed

    Dols, Jean Dowling; Hoke, Mary M; Rauschhuber, Maureen L

    Although it is critical that nurses possess ethical reasoning skills for research, there is limited information on effective strategies to develop these skills in graduate health care students. A research study analyzing educational interventions including the effect of online human subjects training followed by a mock institutional review board simulation demonstrated that knowledge acquisition is not enough to acquire the ethical reasoning skills needed to implement health care research. Situational context is also needed to envision the application of ethical principles.

  8. Ethical international research on human subjects research in the absence of local institutional review boards.

    PubMed

    Bhat, S B; Hegde, T T

    2006-09-01

    International health-related research on human subjects entails unique ethical responsibilities and difficulties. Often, these difficulties are augmented by the lack of a local ethical review infrastructure. In a recent cross-national study conducted by us, three critical components of ethical regulation were identified--external oversight, local oversight and subject involvement--and integrated into the study design. These three concepts are outlined and established as an important aspect of ensuring ethical coherence in the local context, particularly when reviews by the local institutional review boards cannot practically be obtained. The three levels of ethical oversight identified are suggested to be the framework within which future field studies on human subjects are developed and a standard for maintaining ethical rigorousness in research on humans.

  9. E-recruitment based clinical research: notes for Research Ethics Committees/Institutional Review Boards.

    PubMed

    Refolo, P; Sacchini, D; Minacori, R; Daloiso, V; Spagnolo, A G

    2015-01-01

    Patient recruitment is a critical point of today's clinical research. Several proposals have been made for improving it, but the effectiveness of these measures is actually uncertain. The use of Internet (e-recruitment) could represent a great chance to improve patient enrolment, even though the effectiveness of this implementation is not so evident. E-recruitment could bring some advantages, such as better interaction between clinical research demand and clinical research supply, time and resources optimization, and reduction of data entry errors. It raises some issues too, such as sampling errors, validity of informed consent, and protection of privacy. Research Ethics Committees/Institutional Review Boards should consider these critical points. The paper deals with Internet recruitment for clinical research. It also attempts to provide Research Ethics Committees/Institutional Review Boards with notes for assessing e-recruitment based clinical protocols.

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

    PubMed

    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.

  11. Understanding Bureaucracy in Health Science Ethics: Toward a Better Institutional Review Board

    PubMed Central

    Bozeman, Barry; Hirsch, Paul

    2009-01-01

    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. PMID:19608947

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

    PubMed

    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.

  13. "It's like Tuskegee in reverse": a case study of ethical tensions in institutional review board review of community-based participatory research.

    PubMed

    Malone, Ruth E; Yerger, Valerie B; McGruder, Carol; Froelicher, Erika

    2006-11-01

    Community-based participatory research (CBPR) addresses the social justice dimensions of health disparities by engaging marginalized communities, building capacity for action, and encouraging more egalitarian relationships between researchers and communities. CBPR may challenge institutionalized academic practices and the understandings that inform institutional review board deliberations and, indirectly, prioritize particular kinds of research. We present our attempt to study, as part of a CBPR partnership, cigarette sales practices in an inner-city community. We use critical and communitarian perspectives to examine the implications of the refusal of the university institutional review board (in this case, the University of California, San Francisco) to approve the study. CBPR requires expanding ethical discourse beyond the procedural, principle-based approaches common in biomedical research settings. The current ethics culture of academia may sometimes serve to protect institutional power at the expense of community empowerment.

  14. The Ontario Cancer Research Ethics Board: a central REB that works

    PubMed Central

    Chaddah, M.R.

    2008-01-01

    The Ontario Cancer Research Ethics Board (ocreb) has made its mark within Ontario as a successful, centralized, oncology-specific research ethics board. As such, ocreb has proven invaluable to principal investigators, sponsors, and study participants given its ability to reduce duplication during the submission process, to provide the highest quality of review, to shorten study start-up time, and to implement more efficient methods of reporting serious adverse events. PMID:18317585

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

    PubMed

    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.

  16. Should Society Allow Research Ethics Boards to Be Run As For-Profit Enterprises?

    PubMed Central

    Emanuel, Ezekiel J; Lemmens, Trudo; Elliot, Carl

    2006-01-01

    Background to the debate: An important mechanism for protecting human research participants is the prior approval of a clinical study by a research ethics board, known in the United States as an institutional review board (IRB). Traditionally, IRBs have been run by volunteer committees of scientists and clinicians working in the academic medical centers where the studies they review are being carried out. However, for-profit organizations are increasingly being hired to conduct ethics reviews. Proponents of for-profit IRBs argue that these IRBs are just as capable as academic IRBs at providing high-quality ethics reviews. Critics argue that for-profit IRBs have a conflict of interest because they generate their income from clients who have a direct financial interest in obtaining approval. PMID:16848618

  17. Challenges in the Ethical Review of Peer Support Interventions

    PubMed Central

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

    2015-01-01

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

  18. Participatory action research: considerations for ethical review.

    PubMed

    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.

  19. 40 CFR 26.1607 - Human Studies Review Board review of completed human research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Human Studies Review Board review of completed human research. 26.1607 Section 26.1607 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  20. 40 CFR 26.1607 - Human Studies Review Board review of completed human research.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Human Studies Review Board review of completed human research. 26.1607 Section 26.1607 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  1. 40 CFR 26.1606 - Human Studies Review Board review of proposed human research.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical... 40 Protection of Environment 1 2014-07-01 2014-07-01 false Human Studies Review Board review of proposed human research. 26.1606 Section 26.1606 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  2. 40 CFR 26.1606 - Human Studies Review Board review of proposed human research.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... submitted to it by EPA, the Human Studies Review Board must consider the scientific merits and ethical... 40 Protection of Environment 1 2013-07-01 2013-07-01 false Human Studies Review Board review of proposed human research. 26.1606 Section 26.1606 Protection of Environment ENVIRONMENTAL PROTECTION AGENCY...

  3. Ethics Review for Qualitative Inquiry: Adopting a Values-Based, Facilitative Approach

    ERIC Educational Resources Information Center

    Connolly, Kate; Reid, Adela

    2007-01-01

    In many institutions, the institutional review board/research ethics board (IRB/REB) uses the traditional audit approach that emerged from the biomedical community (e.g., Nuremburg Code, Belmont Report) to review the ethical acceptability of research using humans as participants. This approach is guided by participant protection and risk…

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

    PubMed

    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.

  5. Board oversight of community benefit: an ethical imperative.

    PubMed

    Magill, Gerard; Prybil, Lawrence D

    2011-03-01

    Board oversight of community benefit responsibility in tax-exempt organizations in the nonprofit health care sector is attracting considerable attention. Scrutiny by the IRS and other official bodies has led to stricter measures of compliance with the community benefit standard. But stricter compliance does not sufficiently engage the underlying ethical imperative for boards to provide effective oversight--an imperative that recent research suggests has not been sufficiently honored. This analysis considers why there is a distinctively ethical imperative for board oversight, the organizational nature of the imperative involved, and practical ways to fulfill its obligations. We adopt an organizational ethics paradigm to illuminate the constituent components of the ethical imperative and to clarify emerging benchmarks as flexible guidelines. As these emerging benchmarks enhance board oversight of community benefit they also can shed light on what it means to be a virtuous organization.

  6. NCI Central Review Board Receives Accreditation

    Cancer.gov

    The Association for the Accreditation of Human Research Protection Programs has awarded the NCI Central Institutional Review Board full accreditation. AAHRPP awards accreditation to organizations demonstrating the highest ethical standards in clinical res

  7. Institutional ethics review of clinical study agreements

    PubMed Central

    DuVal, G

    2004-01-01

    Accordingly, it is necessary that some independent body have the authority both to review research contracts for compliance with norms of subject protection and ethical integrity, and to reject studies that fail to meet ethical standards. Such review should take place prior to the start of research, not later. Because of its expertise and authority, the institutional ethics review board (IRB or REB) is the appropriate body to undertake such review. Much recent commentary has focused on contractual restrictions on the investigator's freedom to publish research findings. The Olivieri experience, and that of other investigators, has brought freedom of publication issues into sharp focus. Clinical study agreements also raise a number of other ethical issues relating to human subjects and research integrity, however, including disclosures relating to patient safety, data analysis and reporting, budget, confidentiality, and premature termination of the study. This paper describes the ethical issues at stake in structuring such agreements and suggests ethical standards to guide institutional ethics review. PMID:14872068

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

    ERIC Educational Resources Information Center

    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…

  9. 76 FR 2107 - Human Studies Review Board; Notice of Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-12

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0970; FRL-9252-3] Human Studies Review Board... of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and ethical reviews of research with human subjects. DATES: This public meeting will be held on January 26, 2011, from...

  10. Navigating Ethics in the Digital Age: Introducing Connected and Open Research Ethics (CORE), a Tool for Researchers and Institutional Review Boards

    PubMed Central

    Torous, John

    2017-01-01

    Research studies that leverage emerging technologies, such as passive sensing devices and mobile apps, have demonstrated encouraging potential with respect to favorably influencing the human condition. As a result, the nascent fields of mHealth and digital medicine have gained traction over the past decade as demonstrated in the United States by increased federal funding for research that cuts across a broad spectrum of health conditions. The existence of mHealth and digital medicine also introduced new ethical and regulatory challenges that both institutional review boards (IRBs) and researchers are struggling to navigate. In response, the Connected and Open Research Ethics (CORE) initiative was launched. The CORE initiative has employed a participatory research approach, whereby researchers and IRB affiliates are involved in identifying the priorities and functionality of a shared resource. The overarching goal of CORE is to develop dynamic and relevant ethical practices to guide mHealth and digital medicine research. In this Viewpoint paper, we describe the CORE initiative and call for readers to join the CORE Network and contribute to the bigger conversation on ethics in the digital age. PMID:28179216

  11. 75 FR 61748 - Human Studies Review Board; Notice of Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-06

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2010-0797' FRL-9211-1] Human Studies Review Board... of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and ethical reviews of research with human subjects. DATES: This public meeting will be held on October 27-28, 2010, from...

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

    PubMed

    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.

  13. Canadian University Ethics Review: Cultural Complications Translating Principles into Practice

    ERIC Educational Resources Information Center

    Tilley, Susan; Gormley, Louise

    2007-01-01

    Drawing from educational research conducted in Canada and Mexico, university researchers explore how culture complicates both the ethics review process and the translation of ethical research principles into practice. University researchers in Canadian contexts seek approval from university Research Ethics Boards to conduct research, following…

  14. Ethics Regulation in Social Computing Research: Examining the Role of Institutional Review Boards.

    PubMed

    Vitak, Jessica; Proferes, Nicholas; Shilton, Katie; Ashktorab, Zahra

    2017-12-01

    The parallel rise of pervasive data collection platforms and computational methods for collecting, analyzing, and drawing inferences from large quantities of user data has advanced social computing research, investigating digital traces to understand mediated behaviors of individuals, groups, and societies. At the same time, methods employed to access these data have raised questions about ethical research practices. This article provides insights into U.S. institutional review boards' (IRBs) attitudes and practices regulating social computing research. Through descriptive and inferential analysis of survey data from staff at 59 IRBs at research universities, we examine how IRBs evaluate the growing variety of studies using pervasive digital data. Findings unpack the difficulties IRB staff face evaluating increasingly technical research proposals while highlighting the belief in their ability to surmount these difficulties. They also indicate a lack of consensus among IRB staff about what should be reviewed and a willingness to work closely with researchers.

  15. 75 FR 62540 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

    ... 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... Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917; Telephone: 202-482-9300; TTY...

  16. 76 FR 60840 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-30

    ... 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... Government Ethics, Suite 500, 1201 New York Avenue, NW., Washington, DC 20005-3917; Telephone: 202-482-9300...

  17. 78 FR 76148 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-12-16

    ... 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... Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: 202-482-9300...

  18. 77 FR 64521 - Updated OGE Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-22

    ... 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... Government Ethics, Suite 500, 1201 New York Avenue NW., Washington, DC 20005-3917; Telephone: 202-482-9300...

  19. 77 FR 74004 - Human Studies Review Board; Notification of a Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-12-12

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2012-0892; FRL-9761-4] Human Studies Review Board... EPA Office of the Science Advisor announces a public meeting of the Human Studies Review Board to advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This...

  20. Navigating Ethics in the Digital Age: Introducing Connected and Open Research Ethics (CORE), a Tool for Researchers and Institutional Review Boards.

    PubMed

    Torous, John; Nebeker, Camille

    2017-02-08

    Research studies that leverage emerging technologies, such as passive sensing devices and mobile apps, have demonstrated encouraging potential with respect to favorably influencing the human condition. As a result, the nascent fields of mHealth and digital medicine have gained traction over the past decade as demonstrated in the United States by increased federal funding for research that cuts across a broad spectrum of health conditions. The existence of mHealth and digital medicine also introduced new ethical and regulatory challenges that both institutional review boards (IRBs) and researchers are struggling to navigate. In response, the Connected and Open Research Ethics (CORE) initiative was launched. The CORE initiative has employed a participatory research approach, whereby researchers and IRB affiliates are involved in identifying the priorities and functionality of a shared resource. The overarching goal of CORE is to develop dynamic and relevant ethical practices to guide mHealth and digital medicine research. In this Viewpoint paper, we describe the CORE initiative and call for readers to join the CORE Network and contribute to the bigger conversation on ethics in the digital age. ©John Torous, Camille Nebeker. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 08.02.2017.

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

    PubMed

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

    2017-01-01

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

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

    PubMed Central

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

    2017-01-01

    The efforts toward individualized medicine have constantly increased in an attempt to improve treatment options. These efforts have led to the development of small molecules which target specific molecular pathways involved in cancer progression. We have reviewed preclinical studies of sunitinib that incorporate sex as a covariate to explore possible sex-based differences in pharmacokinetics and drug–drug interactions (DDI) to attempt a relationship with published clinical outputs. We observed that covariate sex is lacking in most clinical outcome reports and suggest a series of ethic-based proposals to improve research activities and identify relevant different sex outcomes. We propose a deeper integration of preclinical, clinical, and translational research addressing statistical and clinical significance jointly; to embed specific sex-divergent endpoints to evaluate possible gender differences objectively during all stages of research; to pay greater attention to sex-divergent outcomes in polypharmacy scenarios, DDI and bioequivalence studies; the clear reporting of preclinical and clinical findings regarding sex-divergent outcomes; as well as to encourage the active role of scientists and the pharmaceutical industry to foster a new scientific culture through their research programs, practice, and participation in editorial boards and Institutional Ethics Review Boards (IRBs) and Research Ethics Committees (RECs). We establish the IRB/REC as the centerpiece for the implementation of these proposals. We suggest the expansion of its competence to follow up clinical trials to ensure that sex differences are addressed and recognized; to engage in data monitoring committees to improve clinical research cooperation and ethically address those potential clinical outcome differences between male and female patients to analyze their social and clinical implications in research and healthcare policies. PMID:28785221

  3. 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).

    PubMed

    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.

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

    PubMed Central

    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

    Issue 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. Approach 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. Implications 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. PMID:27443407

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

    PubMed

    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.

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

    PubMed

    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.

  7. Panel urges cloning ethics boards

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

    Marshall, E.

    1997-01-03

    A 7-month review of the system that guides U.S. policy on the ethical, legal, and social issues (ELSI) of the Human Genome Project has concluded that it is time for a radical overhaul. A report completed last month recommends that a high-level policy board be created in the office of the Secretary of Health and Human Services to help develop policies on such sensitive issues as genetic privacy, antidiscrimination legislation, public education on genetic risks, and the regulation of genetic testing. If accepted, the proposal-from a review panel chaired by attorney Mark Rothstein of the University of Houston and geneticistmore » M. Anne Spence of the University of California, Irvine-would create a new panel of 15 to 18 members to serve as {open_quotes}a public forum for discussion of ... critical issues.{close_quotes} This panel would replace the current advisory body, known as the ELSI Working Group, and end what the report calls a {open_quotes}discordance{close_quotes} between the broad scope of the Working Group and the {open_quotes}very limited focus{close_quotes} of the research program under which it operates.« less

  8. Ethical review and informed consent in cardiovascular research reports in Argentina.

    PubMed

    Borracci, Raúl A; Calderón, Gustavo; Seoane, Martín R; Perez, Analía C; Doval, Hernán C

    2008-05-01

    Requirements for Institutional Review Board approval and informed consent for research involving human subjects have existed for more than 2 decades. However, evidence of fulfillment of these requirements is sometimes lacking in cardiovascular research reports in Argentina. Since ethical standards vary between committees, there may be some confusion among researchers regarding the need for an ethical review when conducting low risk research. To examine the frequency of obtaining an ethical review and informed consent in cardiovascular research in Argentina. Through a questionnaire, we contacted authors of 100 reports submitted to our annual scientific meeting during 2006. Thirty six per cent of questionnaires were resubmitted with confirmation of ethical review, 34% responded that ethical review was not obtained, 23% reported as being exempt and 7% were never resubmitted. Most articles obtaining ethical review were pharmacological trials or research involving assessment of new devices. On the other hand, most articles reporting lack of or exemption from ethical review come from epidemiological research or studies evaluating non-invasive methods. Sixty percent of phase IV pharmacological trials, research on cellular implantation or assessment of new devices met federal regulations requirements. The rate of ethical review and use of informed consent in cardiovascular reports in Argentina vary among articles. Most research involving prospective observational studies and nearly 50% of protocols including intervention or invasive procedures do not report ethical review. This high proportion of articles lacking ethical review suggests the presence of legal and ethical flaws which should be discussed and overcome.

  9. New Strategies of Control: Academic Freedom and Research Ethics Boards

    ERIC Educational Resources Information Center

    Lewis, Magda

    2008-01-01

    This article, detailing the implications of "ethics drift" for critical work in the academy, reports on an ethics challenge to a non-research-based scholarly text. It analyzes how General Research Ethics Boards (GREBs) can threaten academic freedom when they lack a clear definition of "human subject" research, fail to…

  10. Ethics review in compassionate use.

    PubMed

    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.

  11. Connections and Tensions between University and School Districts: Research Review Boards and School-Based Research

    ERIC Educational Resources Information Center

    Tilley, Susan A.; Killins, Janet; Van Oosten, Deborah

    2005-01-01

    Currently researchers connected to university contexts who conduct research involving human participants must receive approval from a research ethics board, and in the case of school-based research, from school district authorities. This article focuses on the ethics review of school-based research. Applications submitted to a research ethics…

  12. Understanding community-based processes for research ethics review: a national study.

    PubMed

    Shore, Nancy; Brazauskas, Ruta; Drew, Elaine; Wong, Kristine A; Moy, Lisa; Baden, Andrea Corage; Cyr, Kirsten; Ulevicus, Jocelyn; Seifer, Sarena D

    2011-12-01

    Institutional review boards (IRBs), designed to protect individual study participants, do not routinely assess community consent, risks, and benefits. Community groups are establishing ethics review processes to determine whether and how research is conducted in their communities. To strengthen the ethics review of community-engaged research, we sought to identify and describe these processes. In 2008 we conducted an online survey of US-based community groups and community-institutional partnerships involved in human-participants research. We identified 109 respondents who met participation criteria and had ethics review processes in place. The respondents' processes mainly functioned through community-institutional partnerships, community-based organizations, community health centers, and tribal organizations. These processes had been created primarily to ensure that the involved communities were engaged in and directly benefited from research and were protected from research harms. The primary process benefits included giving communities a voice in determining which studies were conducted and ensuring that studies were relevant and feasible, and that they built community capacity. The primary process challenges were the time and resources needed to support the process. Community-based processes for ethics review consider community-level ethical issues that institution-based IRBs often do not.

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

    PubMed

    Rose, Klaus; Kummer, Hans

    2015-05-28

    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.

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

    PubMed Central

    Rose, Klaus; Kummer, Hans

    2015-01-01

    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. PMID:27417359

  15. The job of 'ethics committees'.

    PubMed

    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/

  16. Guidance and Ethical Considerations for Undertaking Transgender Health Research and Institutional Review Boards Adjudicating this Research

    PubMed Central

    Adams, Noah; Pearce, Ruth; Veale, Jaimie; Radix, Asa; Castro, Danielle; Sarkar, Amrita; Thom, Kai Cheng

    2017-01-01

    Abstract The purpose of this review is to create a set of provisional criteria for Institutional Review Boards (IRBs) to refer to when assessing the ethical orientation of transgender health research proposals. We began by searching for literature on this topic using databases and the reference lists of key articles, resulting in a preliminary set of criteria. We then collaborated to develop the following nine guidelines: (1) Whenever possible, research should be grounded, from inception to dissemination, in a meaningful collaboration with community stakeholders; (2) language and framing of transgender health research should be non-stigmatizing; (3) research should be disseminated back to the community; (4) the diversity of the transgender and gender diverse (TGGD) community should be accurately reflected and sensitively reflected; (5) informed consent must be meaningful, without coercion or undue influence; (6) the protection of participant confidentiality should be paramount; (7) alternative consent procedures should be considered for TGGD minors; (8) research should align with current professional standards that refute conversion, reorientation, or reparative therapy; and (9) IRBs should guard against the temptation to avoid, limit, or delay research on this subject. PMID:29098202

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

    PubMed Central

    2010-01-01

    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. PMID:20637068

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

    PubMed

    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.

  19. Chinese ethics review system and Chinese medicine ethical review: past, present, and future.

    PubMed

    Li, En-Chang; Du, Ping; Ji, Ke-Zhou; Wang, Zhen

    2011-11-01

    The Chinese medical ethics committee and the ethical review system have made the following achievements: (1) enabled the institutionalization of medical ethics, (2) carried out the ethics review of Chinese medicine (CM) and integrative medicine extensively, (3) trained a large number of ethical professionals, (4) supported and protected the interests of patients and subjects, and (5) ensured the correct direction of biological research and provided ethical defense for the publication of its results. However, at the same time, they are also faced with some new problems and difficulties that need to be resolved in the following ways: (1) to refine the relevant rules of ethical review, (2) to develop the relevant standards of the CM and integrative medicine ethical review, (3) to enhance the independence and authority of ethics committee, (4) to emphasize innovation and to discover and solve new problems, and (5) to increase international exchanges and improve relevant research.

  20. Proportional ethical review and the identification of ethical issues

    PubMed Central

    Hunter, D

    2007-01-01

    Presently, there is a movement in the UK research governance framework towards what is referred to as proportional ethical review. Proportional ethical review is the notion that the level of ethical review and scrutiny given to a research project ought to reflect the level of ethical risk represented by that project. Relatively innocuous research should receive relatively minimal review and relatively risky research should receive intense scrutiny. Although conceptually attractive, the notion of proportional review depends on the possibility of effectively identifying the risks and ethical issues posed by an application with some process other than a full review by a properly constituted research ethics committee. In this paper, it is argued that this cannot be achieved and that the only appropriate means of identifying risks and ethical issues is consideration by a full committee. This implies that the suggested changes to the National Health Service research ethics system presently being consulted on should be strenuously resisted. PMID:17400625

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

    PubMed

    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.

  2. A practical perspective on remedial ethics: Minnesota Board of Dentistry.

    PubMed

    Mensing, Candace; Shragg, Marshall

    2009-01-01

    The President and Executive Director of the Minnesota Board of Dentistry describe how the Bebeau course in ethics, for dentists referred because of ethical lapses, is used as part of the disciplinary process in the state. It is understood that breaches of ethical standards are a complex phenomenon, often engaged in by practitioners who know that they are doing wrong but nevertheless choose to do so. Typical patterns of transgression that result in referral to Dr. Bebeau's course include inappropriate billing practices, improper relations with staff or patients, questionable advertising, substandard care, "rough behavior," and gaps in infection control.

  3. Institutional Review Board approval and innovation in urology: current practice and safety issues.

    PubMed

    Sundaram, Varun; Vemana, Goutham; Bhayani, Sam B

    2014-02-01

    To retrospectively review recent publications describing novel procedures/techniques, and describe the Institutional Review Board (IRB)/ethics approval process and potential ethical dilemmas in their reporting. We searched PubMed for papers about innovative or novel procedures/techniques between 2011 and August 2012. A query of titles/abstracts in the Journal of Urology, Journal of Endourology, European Urology, BJU International, and Urology identified relevant papers. These results were reviewed for human studies that described an innovative technique, procedure, approach, initial series, and/or used new technology. In all, 91 papers met criteria for inclusion; 25 from the Journal of Endourology, 14 from the Journal of Urology, nine from European Urology, 15 from the BJU International and 28 from Urology. IRB/ethics approval was given for an experimental procedure or database in 24% and 22%, respectively. IRB/ethics approval was not mentioned in 52.7% of studies. Published IRB/ethics approvals for innovative techniques are heterogeneous including database, retrospective, and prospective approvals. Given the concept that innovations are likely not in the legal or ethical standard of care, strong consideration should be given to obtaining IRB/ethics approval before the actual procedure, instead of approval to merely report database outcomes. © 2013 The Authors. BJU International © 2013 BJU International.

  4. Teaching ethics and professionalism in plastic surgery: a systematic review.

    PubMed

    de Blacam, Catherine; Vercler, Christian J

    2014-04-01

    Maintenance of the highest ethical and professional standards in plastic surgery is in the best interests of our profession and the public whom we serve. Both the American Board of Medical Specialties and the Accreditation Council on Graduate Medical Education mandate training in ethics and professionalism for all residents. Presently there is no gold standard in ethics and professionalism education. A systematic review on teaching ethics and professionalism in plastic surgery was performed for all articles from inception to May 23, 2013 in MEDLINE, Scopus, EMBASE, CENTRAL, and ERIC. References of relevant publications were searched for additional papers. Key journals were hand searched and relevant conference proceedings were also reviewed. Duplicate and non-English articles were excluded. Inclusion and exclusion criteria were applied to find articles that described a curriculum in ethics and/or professionalism in plastic surgery. Two hundred twenty-seven relevant articles were identified. One hundred seventy-four did not meet inclusion criteria based on screening of the title, and 39 of those did not meet inclusion criteria based on screening of the abstract or introductory paragraph. Of the 14 identified for full text review, only 2 articles described a set curriculum in ethics and/or professionalism in plastic surgery training and reported outcomes. A paucity of data exists regarding the structure, content, or relevant measures that can be applied to assess outcomes of a curriculum to teach ethics and professionalism to plastic surgery trainees. Endeavors to teach ethics and professionalism to plastic surgery trainees must rigorously document the process and outcomes to facilitate the maintenance of our profession.

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

    PubMed

    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.

  6. Publication bias in the medical literature: a review by a Canadian Research Ethics Board.

    PubMed

    Hall, Richard; de Antueno, Cecilia; Webber, Adam

    2007-05-01

    We reviewed the publication record of all protocols submitted to the Capital District Health Authority Research Ethics Board (REB) in Halifax, Nova Scotia, for the period 1995-1996. Because of a heightened awareness of the issue, we hypothesized that there would be less publication bias (a failure to report negative results) and a higher publication rate from completed studies, than previously reported. Closed studies were identified from the REB database. Publications were identified by the investigators, requests from sponsors, and a literature review. For each publication, we identified authors, title, journal, number of subjects enrolled, and whether or not the publication was a report of a randomized clinical trial. Comparisons were done using a Student's t test, the Chi-square statistic, or Fisher's exact test as appropriate. From the database of closed studies, 106 remained unpublished, while completed investigations resulted in 84 publications (44% publication rate). The median time to publication was 32.5 months. Publication of statistically significant results occurred in 71/84 trials. Publication of protocols submitted by departments ranged from 91% (anesthesia; 10/11) to 25% [nursing; 2/8 (P<0.05)]. Trials investigating new drugs in Phase 3 or 4 studies were more likely to be published than trials investigating agents in Phase 1 or 2 (P<0.05), and were less likely to be published if sponsored by a pharmaceutical company (P<0.05). Publication bias continues to be a problem, particularly for early phase investigative studies. Our results suggest that a different approach is required to reduce publication bias. The role that REBs and peer-reviewed journals might play requires further exploration.

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

    PubMed

    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

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

    PubMed

    Ezzat, Hanna; Ross, Sue; von Dadelszen, Peter; Morris, Tara; Liston, Robert; Magee, Laura A

    2010-07-30

    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. 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. 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. 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.

  9. Ethical standards for mental health and psychosocial support research in emergencies: review of literature and current debates.

    PubMed

    Chiumento, Anna; Rahman, Atif; Frith, Lucy; Snider, Leslie; Tol, Wietse A

    2017-02-08

    Research in emergencies is needed to understand the prevalence of mental health and psychosocial problems and strengthen the evidence base for interventions. All research - including operational needs assessments, programme monitoring and evaluation, and formal academic research - must be conducted ethically. While there is broad consensus on fundamental principles codified in research ethics guidelines, these do not address the ethical specificities of conducting mental health and psychosocial support (MHPSS) research with adults in emergencies. To address this gap, this paper presents a review of multidisciplinary literature to identify specific ethical principles applicable to MHPSS research in emergencies. Fifty-nine sources meeting the literature review inclusion criteria were analysed following a thematic synthesis approach. There was consensus on the relevance of universal ethical research principles to MHPSS research in emergencies, including norms of participant informed consent and protection; ensuring benefit arises from research participation; researcher neutrality, accountability, and safety; and the duty to ensure research is well designed and accounts for contextual factors in emergency settings. We go onto discuss unresolved issues by highlighting six current debates relating to the application of ethics in emergency settings: (1) what constitutes fair benefits?; (2) how should informed consent be operationalised?; (3) is there a role for decision making capacity assessments?; (4) how do risk management approaches impact upon the construction of ethical research?; (5) how can ethical reflection best be achieved?, and (6) are ethical review boards sufficiently representative and equipped to judge the ethical and scientific merit of emergency MHPSS research? Underlying these debates is a systemic tension between procedural ethics and ethics in practice. In summary, underpinning the literature is a desire to ensure the protection of participants

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

    PubMed

    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.

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

    PubMed Central

    2010-01-01

    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. PMID:20673343

  12. Technical Review Board Chairperson Guidelines for Conducting Technical Review Boards for Rocket Testing

    DTIC Science & Technology

    2011-08-17

    to create a guide for technical review board chairperson conducting technical review boards for rocket testing performed by the Air Force Research ...BOARDS FOR ROCKET TESTING   TABLE OF CONTENTS List of Acronyms 1 Abstract 2 Chapter 1. Introduction 3 Introduction and Research Question 3...boards for rocket testing performed by the Air Force Research Laboratory’s Space Missile Propulsion Division located at Edwards Air Force Base in

  13. 77 FR 60146 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... NATIONAL TRANSPORTATION SAFETY BOARD SES Performance Review Board AGENCY: National Transportation... National Transportation Safety Board, Performance Review Board (PRB). FOR FURTHER INFORMATION CONTACT... Performance Review Boards. The board reviews and evaluates the initial appraisal of a senior executive's...

  14. 76 FR 70169 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-10

    ... NATIONAL TRANSPORTATION SAFETY BOARD SES Performance Review Board AGENCY: National Transportation... National Transportation Safety Board, Performance Review Board (PRB). FOR FURTHER INFORMATION CONTACT... Performance Review Boards. The board reviews and evaluates the initial appraisal of a senior executive's...

  15. 75 FR 69706 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-15

    ... NATIONAL TRANSPORTATION SAFETY BOARD SES Performance Review Board AGENCY: National Transportation... National Transportation Safety Board Performance Review Board (PRB). FOR FURTHER INFORMATION CONTACT: Emily... Review Boards. The board reviews and evaluates the initial appraisal of a senior executive's performance...

  16. Ethical aspects of human biobanks: a systematic review

    PubMed Central

    Budimir, Danijela; Polašek, Ozren; Marušić, Ana; Kolčić, Ivana; Zemunik, Tatijana; Boraska, Vesna; Jerončić, Ana; Boban, Mladen; Campbell, Harry; Rudan, Igor

    2011-01-01

    Aim To systematically assess the existing literature on ethical aspects of human biobanks. Method We searched the Web of Science and PubMed databases to find studies addressing ethical problems in biobanks with no limits set (study design, study population, time period, or language of publication). All identified articles published until November 2010 were included. We analyzed the type of published articles, journals publishing them, involvement of countries/institutions, year of publication, and citations received, and qualitatively assessed every article in order to identify ethical issues addressed by the majority of published research on human biobanking. Results Hundred and fifty four studies satisfied our review criteria. The studies mainly came from highly developed countries and were all published in the last two decades, with over half of them published in 2009 or 2010. They most commonly discussed the informed consent, privacy and identifiability, return of results to participants, importance of public trust, involvement of children, commercialization, the role of ethics boards, international data exchange, ownership of samples, and benefit sharing. Conclusions The focus on ethical aspects is strongly present through the whole biobanking research field. Although there is a consensus on the old and most typical ethical issues, with further development of the field and increasingly complex structure of human biobanks, these issues will likely continue to arise and accumulate, hence requiring constant re-appraisal and continuing discussion. PMID:21674823

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

    PubMed

    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.

  18. Ethical review of health research: a perspective from developing country researchers.

    PubMed

    Hyder, A A; Wali, S A; Khan, A N; Teoh, N B; Kass, N E; Dawson, L

    2004-02-01

    Increasing collaboration between industrialised and developing countries in human research studies has led to concerns regarding the potential exploitation of resource deprived countries. This study, commissioned by the former National Bioethics Advisory Commission of the United States, surveyed developing country researchers about their concerns and opinions regarding ethical review processes and the performance of developing country and US international review boards (IRBs). Contact lists from four international organisations were used to identify and survey 670 health researchers in developing countries. A questionnaire with 169 questions explored issues of IRB review, informed consent, and recommendations. The majority of the developing country researchers were middle aged males who were physicians and were employed by educational institutions, carrying out research on part time basis. Forty four percent of the respondents reported that their studies were not reviewed by a developing country IRB or Ministry of Health and one third of these studies were funded by the US. During the review process issues such as the need for local language consent forms and letters for approval, and confidentiality protection of participants were raised by US IRBs in significantly higher proportions than by host country IRBs. This survey indicates the need for the ethical review of collaborative research in both US and host countries. It also reflects a desire for focused capacity development in supporting ethical review of research.

  19. Expanding Ethics Review Processes to Include Community-Level Protections: A Case Study from Flint, Michigan.

    PubMed

    Key, Kent D

    2017-10-01

    As the Flint community endeavors to recover and move forward in the aftermath of the Flint water crisis, distrust of scientific and governmental authorities must be overcome. Future community engagement in research will require community-level protections ensuring that no further harm is done to the community. A community ethics review explores risks and benefits and complements institutional review board (IRB) review. Using the case of Flint, I describe how community-level ethical protections can reestablish a community's trust. All IRBs reviewing protocols that include risk to communities and not merely individual participants should consider how community members are engaged in the proposed research and identify and respond to questions and domains of concern from community members. © 2017 American Medical Association. All Rights Reserved.

  20. 75 FR 34519 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-06-17

    ... TRADE AND DEVELOPMENT AGENCY SES Performance Review Board AGENCY: U.S. Trade and Development... and Development Agency's Performance Review Board. FOR FURTHER INFORMATION CONTACT: Carolyn Hum... more SES Performance Review Boards. The Board shall review and evaluate the initial appraisal of a...

  1. 77 FR 66824 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-07

    ... DEPARTMENT OF DEFENSE Department of the Army Performance Review Board Membership AGENCY... Performance Review Board for the Department of the Army. DATES: Effective Date: November 15, 2012. FOR FURTHER... performance review boards. The boards shall review and evaluate the initial appraisal of senior executives...

  2. 75 FR 70915 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-19

    ... DEPARTMENT OF DEFENSE Department of the Army Performance Review Board Membership AGENCY... Performance Review Board for the Department of the Army. DATES: Effective Date: November 16, 2010. FOR FURTHER... performance review boards. The boards shall review and evaluate the initial appraisal of senior executives...

  3. 76 FR 70428 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-14

    ... DEPARTMENT OF DEFENSE Department of the Army Performance Review Board Membership AGENCY... Performance Review Board for the Department of the Army. DATES: Effective Date: November 14, 2011. FOR FURTHER... performance review boards. The boards shall review and evaluate the initial appraisal of senior executives...

  4. 78 FR 63460 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-10-24

    ... DEPARTMENT OF DEFENSE Department of the Army Performance Review Board Membership AGENCY... Performance Review Board for the Department of the Army. DATES: Effective Date: November 21, 2013. FOR FURTHER... performance review boards. The boards shall review and evaluate the initial appraisal of senior executives...

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

    PubMed

    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.

  6. 78 FR 68464 - Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-14

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5746-N-01] Performance Review Board.... Valentine, and Mary E. McBride as members of the Departmental Performance Review Board. The address is... INFORMATION CONTACT: Persons desiring any further information about the Performance Review Board and its...

  7. 77 FR 59002 - Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-09-25

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5665-N-01] Performance Review Board.... Kinney, Jean Lin Pao, and Susan J. Shuback as members of the Departmental Performance Review Board. The... INFORMATION CONTACT: Persons desiring any further information about the Performance Review Board and its...

  8. Unesco's Global Ethics Observatory

    PubMed Central

    Have, H ten; Ang, T W

    2007-01-01

    The Global Ethics Observatory, launched by the United Nations Educational, Scientific, and Cultural Organization in December 2005, is a system of databases in the ethics of science and technology. It presents data on experts in ethics, on institutions (university departments and centres, commissions, councils and review boards, and societies and associations) and on teaching programmes in ethics. It has a global coverage and will be available in six major languages. Its aim is to facilitate the establishment of ethical infrastructures and international cooperation all around the world. PMID:17209103

  9. 75 FR 746 - Naval Discharge Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-06

    ... Naval Discharge Review Board AGENCY: Department of the Navy, DoD. ACTION: Final rule. SUMMARY: The... of Personnel Boards to the Secretary of the Navy Council of Review Boards and to update other administrative information pertaining to the Naval Discharge Review Board. DATES: This rule is effective January...

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

    PubMed

    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

  11. 78 FR 69093 - Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... Review Board Members AGENCY: Centers for Disease Control and Prevention (CDC), Department of Health and... Performance Review Board Members who are reviewing performance for Fiscal Year 2013. FOR FURTHER INFORMATION... Performance Review Board Members be published in the Federal Register. The following persons will serve on the...

  12. 76 FR 35399 - SES Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-06-17

    ... BROADCASTING BOARD OF GOVERNORS SES Performance Review Board Membership AGENCY: Broadcasting Board of Governors (BBG). ACTION: Notice of Membership of SES Performance Review Board. SUMMARY: Title 5... member of a performance review board (PRB) shall be published in the Federal Register. The following...

  13. 75 FR 60125 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ... FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY: Federal Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of members to the FTC Performance Review Board... the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314(c)(4). The PRB reviews and...

  14. 77 FR 33460 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-06

    ... FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY: Federal Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of members to the FTC Performance Review Board...., Washington, DC 20580, (202) 326- 3633. SUPPLEMENTARY INFORMATION: Publication of the Performance Review Board...

  15. [Responsibilities of ethics committees].

    PubMed

    von Bergmann, K

    1999-01-15

    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.

  16. [Responsibilities of ethics committees].

    PubMed

    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.

  17. 77 FR 61379 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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..., Associate Under Secretary for Management Chair, Performance Review Board. [FR Doc. 2012-24510 Filed 10-5-12...

  18. 75 FR 75489 - The Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-03

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5468-N-01] The Performance Review Board... Departmental Performance Review Board. The address is: Department of Housing and Urban Development, Washington... Performance Review Board and its members may contact Gwendolyn Fleming, Deputy Director, Office of Executive...

  19. 76 FR 73654 - The Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-11-29

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5589-N-01] The Performance Review Board... Review Board. The address is: Department of Housing and Urban Development, Washington, DC 20410-0050. FOR FURTHER INFORMATION CONTACT: Persons desiring any further information about the Performance Review Board...

  20. 78 FR 56703 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-13

    ... FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY: Federal Trade Commission. ACTION... Performance Review Board. FOR FURTHER INFORMATION CONTACT: Karen Leydon, Chief Human Capital Officer, Federal... INFORMATION: Publication of the Performance Review Board (PRB) membership is required by 5 U.S.C. 4314(c)(4...

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

    PubMed

    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.

  2. 78 FR 19278 - The Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-29

    ... DEPARTMENT OF HOUSING AND URBAN DEVELOPMENT [Docket No. FR-5702-N-01] The Performance Review Board.... Shuback as members of the Departmental Performance Review Board. The address is: Department of Housing and... further information about the Performance Review Board and its members may contact Juliette Middleton...

  3. 78 FR 69097 - Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-18

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members Title 5, U.S.C. Section... Performance Review Board Members be published in the Federal Register. The following persons may be named to serve on the Performance Review Boards or Panels, which oversee the evaluation of performance appraisals...

  4. Ethics in research.

    PubMed

    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.

  5. 32 CFR 724.102 - Naval Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Naval Discharge Review Board. 724.102 Section 724.102 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Definitions § 724.102 Naval Discharge Review Board. An administrative board, referred...

  6. 32 CFR 724.102 - Naval Discharge Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false Naval Discharge Review Board. 724.102 Section 724.102 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Definitions § 724.102 Naval Discharge Review Board. An administrative board, referred...

  7. Professional ethics in nursing: an integrative review.

    PubMed

    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.

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

    PubMed

    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.

  9. 32 CFR 881.3 - Individual Service Review Board.

    Code of Federal Regulations, 2010 CFR

    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...

  10. 75 FR 56999 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-17

    ... 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... performance review boards. The PRB shall review and evaluate the initial summary rating of the senior...

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

    PubMed

    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.

  12. 49 CFR 826.38 - Board review.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 7 2010-10-01 2010-10-01 false Board review. 826.38 Section 826.38 Transportation... IMPLEMENTING THE EQUAL ACCESS TO JUSTICE ACT OF 1980 Procedures for Considering Applications § 826.38 Board review. Either the applicant or agency counsel may seek review of the initial decision on the fee...

  13. 5 CFR 1639.52 - Board review.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... § 1639.52 Board review. (a) A debtor may dispute the existence of the debt, the amount of debt, or the... records concerning the disputed claim, the Board will grant 10 business days for the review. The time...

  14. Internet-based crowdsourcing and research ethics: the case for IRB review.

    PubMed

    Graber, Mark A; Graber, Abraham

    2013-02-01

    The recent success of Foldit in determining the structure of the Mason-Pfizer monkey virus (M-PMV) retroviral protease is suggestive of the power-solving potential of internet-facilitated game-like crowdsourcing. This research model is highly novel, however, and thus, deserves careful consideration of potential ethical issues. In this paper, we will demonstrate that the crowdsourcing model of research has the potential to cause harm to participants, manipulates the participant into continued participation, and uses participants as experimental subjects. We conclude that protocols relying on this model require institutional review board (IRB) scrutiny.

  15. 75 FR 80051 - Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-21

    ... FEDERAL MARITIME COMMISSION Performance Review Board AGENCY: Federal Maritime Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the names of the members of the Performance Review Board. FOR FURTHER INFORMATION CONTACT: Harriette H. Charbonneau, Director of Human Resources, Federal Maritime...

  16. 77 FR 4819 - Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-01-31

    ... FEDERAL MARITIME COMMISSION Performance Review Board AGENCY: Federal Maritime Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the names of the members of the Performance Review Board. FOR FURTHER INFORMATION CONTACT: Harriette H. Charbonneau, Director of Human Resources, Federal Maritime...

  17. 77 FR 39677 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-07-05

    ... ARCHITECTURAL AND TRANSPORTATION BARRIERS COMPLIANCE BOARD Performance Review Board Membership AGENCY: Architectural and Transportation Barriers Compliance Board. ACTION: Notice. SUMMARY: Notice is... Transportation Barriers Compliance Board (Access Board). FOR FURTHER INFORMATION CONTACT: David M. Capozzi...

  18. 76 FR 39401 - Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-06

    ... FEDERAL COMMUNICATIONS COMMISSION Performance Review Board AGENCY: Federal Communications Commission. ACTION: Notice. As required by the Civil Service Reform Act of 1978 (Pub. L. 95- 454), Chairman Julius Genachowski appointed the following executive to the Performance Review Board (PRB): Mindel De La...

  19. 5 CFR 317.502 - Qualifications Review Board certification.

    Code of Federal Regulations, 2010 CFR

    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...

  20. 32 CFR 724.303 - Functions: President, Naval Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Functions: President, Naval Discharge Review... PERSONNEL NAVAL DISCHARGE REVIEW BOARD Director, Secretary of the Navy Council of Review Boards and President Naval Discharge Review Board; Responsibilities in Support of the Naval Discharge Review Board...

  1. 32 CFR 724.303 - Functions: President, Naval Discharge Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false Functions: President, Naval Discharge Review... PERSONNEL NAVAL DISCHARGE REVIEW BOARD Director, Secretary of the Navy Council of Review Boards and President Naval Discharge Review Board; Responsibilities in Support of the Naval Discharge Review Board...

  2. Health research ethics review and needs of institutional ethics committees in Tanzania.

    PubMed

    Ikingura, J K B; Kruger, M; Zeleke, W

    2007-09-01

    This study was undertaken to describe the performance of health research ethics review procedures of six research centres in Tanzania. Data collection was done through a self-administered questionnaire and personal interviews. The results showed that there were on average 11 members (range = 8-14) in each Research Ethic Committee. However, female representation in the committees was low (15.2%). The largest proportion of the committee members was biomedical scientists (51.5%). Others included medical doctors (19.7%), social scientists (7.6%), laboratory technologists (10.6%), religious leaders (4.5%), statisticians (3.0%), teachers (1.5%) and lawyers (1.5). Committee members had different capacities to carry out review of research proposals (no capacity = 2%; limited capacity = 15%; moderate capacity = 20%; good capacity = 48%, excellent capacity = 13%). Only half of the respondents had prior ethics review training. Although the majority deemed that ethical guidelines were very important (66%), there were challenges in the use of ethical guidelines which included lack of awareness on the national accreditation mechanisms for ethics committee (59%). Adherence to ethical principles and regulations was influenced by being a scientist (OR = 42.47), being an employee of a professional organization (OR = 15.25), and having an interests in the use of ethical guidelines (OR = 10.85) These findings indicate the need for capacity strengthening (through training and resource support), inclusion of more female representation and other mandatory professions to the research ethics committees.

  3. [Role of Institutional Review Boards for multi-centre studies in national health services research - a cross-sectional study of the effort to obtain secondary ethical approvals for the DACAPO study].

    PubMed

    Blecha, Sebastian; Thomann-Hackner, Kathrin; Brandstetter, Susanne; Dodoo-Schittko, Frank; Seboek, Philipp; Apfelbacher, Christian; Graf, Bernhard M; Bein, Thomas

    2015-09-01

    Health services research (HSR) is of fundamental importance for the continuous improvement of preventive, diagnostic or therapeutic measures. The conduct of multi-centre HSR studies requires that ethical approval by Institutional review boards (IRB's) is obtained. We documented the effort, the complexity and the man power necessary to obtain secondary ethical approval for a national HSR in Germany ("Surviving the Acute Respiratory Distress Syndrome" [DACAPO-study]). Having obtained a primary ethical approval by the IRB of Regensburg University, the time, correspondence, necessity for amendments, corrections, or additional costs by 34 IRB's for 64 participating study centers was documented. The complete obtainment was found to be time consuming and associated with a high workload and man power. A time span of seven month was needed to receive votes from all IRB's. The median time span was 25,5 days (25 %/75 % percentile 13 and 42 days, respectively). Requirements in terms of corrections or amendments were inhomogeneous and frequent changes were necessary. There were additional fees for secondary votes of 4328,40 €. Total costs for the study center Regensburg were 21.193,40 € (2,6 % of the grant volume). Obtaining all ethical approvals for a multi-centre observational HSR study in Germany is complex and time consuming. Various and inhomogeneous formalities may delay the plan and realization of HSR. A Homogenization and simplification of the procedure of ethics votes should be discussed. © Georg Thieme Verlag KG Stuttgart · New York.

  4. Current state of ethics literature synthesis: a systematic review of reviews.

    PubMed

    Mertz, Marcel; Kahrass, Hannes; Strech, Daniel

    2016-10-03

    Modern standards for evidence-based decision making in clinical care and public health still rely solely on eminence-based input when it comes to normative ethical considerations. Manuals for clinical guideline development or health technology assessment (HTA) do not explain how to search, analyze, and synthesize relevant normative information in a systematic and transparent manner. In the scientific literature, however, systematic or semi-systematic reviews of ethics literature already exist, and scholarly debate on their opportunities and limitations has recently bloomed. A systematic review was performed of all existing systematic or semi-systematic reviews for normative ethics literature on medical topics. The study further assessed how these reviews report on their methods for search, selection, analysis, and synthesis of ethics literature. We identified 84 reviews published between 1997 and 2015 in 65 different journals and demonstrated an increasing publication rate for this type of review. While most reviews reported on different aspects of search and selection methods, reporting was much less explicit for aspects of analysis and synthesis methods: 31 % did not fulfill any criteria related to the reporting of analysis methods; for example, only 25 % of the reviews reported the ethical approach needed to analyze and synthesize normative information. While reviews of ethics literature are increasingly published, their reporting quality for analysis and synthesis of normative information should be improved. Guiding questions are: What was the applied ethical approach and technical procedure for identifying and extracting the relevant normative information units? What method and procedure was employed for synthesizing normative information? Experts and stakeholders from bioethics, HTA, guideline development, health care professionals, and patient organizations should work together to further develop this area of evidence-based health care.

  5. The ethics of peer review in bioethics

    PubMed Central

    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

  6. 77 FR 65685 - Senior Executive Service Performance Review Board; Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  7. Ethical issues: the multi-centre low-risk ethics/governance review process and AMOSS.

    PubMed

    Vaughan, Geraldine; Pollock, Wendy; Peek, Michael J; Knight, Marian; Ellwood, David; Homer, Caroline S; Pulver, Lisa Jackson; McLintock, Claire; Ho, Maria T; Sullivan, Elizabeth A

    2012-04-01

    The Australasian Maternity Outcomes Surveillance System (AMOSS) conducts surveillance and research of rare and serious conditions in pregnancy. This multi-centre population health study is considered low risk with minimal ethical impact. To describe the ethics/governance review pathway undertaken by AMOSS. Prospective, descriptive study during 2009-2011 of the governance/ethical review processes required to gain approval for Australian and New Zealand (ANZ) maternity units with more than 50 births per year (n = 303) to participate in AMOSS. Review processes ranged from a single application for 24 NZ sites, a single application for eligible hospitals in two Australian states, full Health Research Ethics Committee (HREC) applications for individual hospitals, through simple letters of support. As of September 2011, 46 full/expedited ethics applications, 131 site governance applications and 136 letters of support requests were made over 33 months, involving an estimated 3261 hours by AMOSS staff/investigators, and an associated resource burden by participating sites, to obtain approval to receive nonidentifiable data from 291 hospitals. The AMOSS research system provides an important resource to enhance knowledge of conditions that cause rare and serious maternal morbidity. Yet the highly variable ethical approval processes required to implement this study have been excessively repetitive and burdensome. This process jeopardises timely, efficient research project implementation, without corresponding benefits to research participants. The resource burden to establish research governance for AMOSS confirms the urgent need for the Harmonisation of Multi-centre Ethical Review (HoMER) to further streamline ethics/governance review processes for multi-centre research. © 2011 The Authors. Australian and New Zealand Journal of Obstetrics and Gynaecology © 2011 The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.

  8. Organizational ethics: a literature review.

    PubMed

    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

  9. 77 FR 54570 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

  11. 77 FR 64969 - Senior Executive Service; Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  12. 76 FR 70713 - Senior Executive Service; Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  13. 77 FR 66191 - Senior Executive Service-Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  14. 75 FR 69063 - Senior Executive Service; Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  15. 78 FR 70029 - Senior Executive Service; Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  16. 75 FR 57440 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-21

    ... DEPARTMENT OF COMMERCE Performance Review Board Membership AGENCY: Economics and Statistics Administration, Commerce. ACTION: Notice. SUMMARY: Below is a listing of individuals who are eligible to serve on the Performance Review Board in accordance with the Economics and Statistics Administration's Senior...

  17. 76 FR 57712 - Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... DEPARTMENT OF COMMERCE Performance Review Board Membership AGENCY: Economics and Statistics Administration, Commerce. ACTION: Notice. SUMMARY: Below is a listing of individuals who are eligible to serve on the Performance Review Board (PRB) in accordance with the Economics and Statistics Administration's...

  18. A CITIZENS' REVIEW BOARD FOR TEACHERS.

    ERIC Educational Resources Information Center

    SPENCER, DAVID; AND OTHERS

    IN A DIALOGUE ON THE VALUE OF ESTABLISHING A CITIZENS REVIEW BOARD WHICH WOULD HAVE A VOICE IN SELECTING AND RETAINING TEACHERS IN GHETTO SCHOOLS, TWO OPPOSING VIEWS ARE STATED BY A PARENT INVOLVED IN NEW YORK CITY'S I.S. 201 SCHOOL CONTROVERSY, WHICH STIMULATED THE IDEA OF A REVIEW BOARD, AND THE PRESIDENT OF THE LOCAL CHAPTER OF THE AMERICAN…

  19. 5 CFR 1501.9 - Cases reviewable by the Board.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 5 Administrative Personnel 3 2010-01-01 2010-01-01 false Cases reviewable by the Board. 1501.9 Section 1501.9 Administrative Personnel THE INTERNATIONAL ORGANIZATIONS EMPLOYEES LOYALTY BOARD OPERATIONS OF THE INTERNATIONAL ORGANIZATIONS EMPLOYEES LOYALTY BOARD § 1501.9 Cases reviewable by the Board...

  20. 20 CFR 405.405 - Decision Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Decision Review Board. 405.405 Section 405.405 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW PROCESS FOR ADJUDICATING... judge's decision has been effectuated to study our disability determination process. If the Board...

  1. 75 FR 57987 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-23

    ... the Office of Personnel Management, one or more SES Performance Review Boards. The Board shall review.... Larry Baden--Deputy Chairman for Management and Budget. Michael Burke--Chief Information Officer. Sunil Iyengar--Director, Research & Analysis. William O'Brien--Senior Advisor for Program Innovation. Kathleen...

  2. 76 FR 51368 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-18

    ... FEDERAL TRADE COMMISSION SES Performance Review Board AGENCY: Federal Trade Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of members to the FTC Performance Review Board..., NW., Washington, DC 20580, (202) 326- 3633. SUPPLEMENTARY INFORMATION: Publication of the Performance...

  3. Ethics and Community Involvement in Syntheses Concerning American Indian, Alaska Native, or Native Hawaiian Health: A Systematic Review

    PubMed Central

    Around Him, Deana M.

    2014-01-01

    Background The objective of the research was to review reporting of ethical concerns and community involvement in peer-reviewed systematic reviews or meta-analyses concerning American Indian, Alaska Native, or Native Hawaiian (AI/AN/NH) health. Methods Text words and indexed vocabulary terms were used to query PubMed, Embase, Cochrane Library, and the Native Health Database for systematic reviews or meta-analyses concerning AI/AN/NH health published in peer-reviewed journals, followed by a search through reference lists. Each article was abstracted by two independent reviewers; results were discussed until consensus was reached. Results We identified 107 papers published from 1986–2012 that were primarily about AI/AN/NH health or presented findings separately for AI/AN/NH communities. Two reported seeking indigenous reviewer feedback; none reported seeking input from tribes and communities. Approximately 7% reported on institutional review board (IRB) approval of included studies, 5% reported on tribal approval, and 4% referenced the sovereignty of AI/AN tribes. Approximately 63% used evidence from more than one AI/AN/NH population study, and 28% discussed potential benefits to communities from the synthesis research. Conclusions Reporting of ethics and community involvement are not prominent. Systematic reviews and meta-analyses making community-level inferences may pose risks to communities. Future systematic reviews and meta-analyses should consider ethical and participatory dimensions of research. PMID:25089283

  4. The ethics of peer review in bioethics.

    PubMed

    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.

  5. 32 CFR 724.403 - President, Naval Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false President, Naval Discharge Review Board. 724.403 Section 724.403 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL..., Naval Discharge Review Board. Supervises the Naval Discharge Review Board. (See subpart C). ...

  6. 32 CFR 724.403 - President, Naval Discharge Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false President, Naval Discharge Review Board. 724.403 Section 724.403 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL..., Naval Discharge Review Board. Supervises the Naval Discharge Review Board. (See subpart C). ...

  7. Legal liability and research ethics boards: the case of neuroimaging and incidental findings.

    PubMed

    Zarzeczny, Amy; Caulfield, Timothy

    2012-01-01

    Neuroimaging research covers a wide range of intriguing issues from revealing brain structures to investigating what happens in our brain when we lie. The field appears to be thriving, but skepticism and alertness to the various ethical, scientific, policy and philosophical challenges associated with it also appear to be on the rise. One particularly complex issue concerns what to do with incidental findings that emerge during the course of neuroimaging research. Research ethics boards (REBs) play a central role in research oversight. In this paper, we will consider some of the potential issues associated with REB liability in negligence in the context of incidental findings in neuroimaging research. Copyright © 2011 Elsevier Ltd. All rights reserved.

  8. Board Certified Behavior Analysts and Related Ethical and Professional Practice Considerations for Rural Schools

    ERIC Educational Resources Information Center

    Menendez, Anthony L.; Mayton, Michael R.; Yurick, Amanda L.

    2017-01-01

    When rural school districts employ Board Certified Behavior Analysts (BCBAs) to assist in meeting the needs of students with disabilities, it is important that they be aware of the ethical and professional guidelines to which BCBAs are required to adhere. This article describes the role of these guidelines within the practice of BCBAs and presents…

  9. 78 FR 42807 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-07-17

    ... the Office of Personnel Management, one or more SES Performance Review Boards. The Board shall review... Management and Budget Sunil Iyengar--Director, Research & Analysis William O'Brien--Senior Advisor for Program Innovation Kathy Plowitz-Worden, Panel Coordinator, National Endowment for the Arts. [FR Doc. 2013...

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

    PubMed

    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.

  11. Getting the justification for research ethics review right.

    PubMed

    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.

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

    PubMed

    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.

  13. 77 FR 62211 - Senior Executive Services (SES) Performance Review Board: Update

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

  15. A review of ethical issues in dementia.

    PubMed

    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.

  16. 78 FR 77125 - Senior Executive Service Performance Review Board; Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  17. Capacity for ethical and regulatory review of herbal trials in developing countries: a case study of Moringa oleifera research in HIV-infected patients.

    PubMed

    Monera-Penduka, Tsitsi G; Maponga, Charles C; Morse, Gene D; Nhachi, Charles F B

    2017-01-01

    Lack of regulatory capacity limits the conduct of ethical and rigorous trials of herbal medicines in developing countries. Sharing ethical and regulatory experiences of successful herbal trials may accelerate the field while assuring human subjects protection. The methods and timelines for the ethical and regulatory review processes for the first drug regulatory authority approved herbal trial in Zimbabwe are described in this report. The national drug regulatory authority and ethics committee were engaged for pre-submission discussions. Six applications were submitted. Application procedures and communications with the various regulatory and ethics review boards were reviewed. Key issues raised and timelines for communications were summarized. There was no special framework for the approval of herbal trials. One local institutional review committee granted an exemption. Key issues raised for revision were around pre-clinical efficacy and safety data, standardization and quality assurance of the intervention as well as consenting procedures. Approval timelines ranged between eight and 72 weeks. In the absence of a defined framework for review of herbal trials, approval processes can be delayed. Dialogue between researchers and regulators is important for successful and efficient protocol approval for herbal trials in developing countries. The study was registered prospectively on August 3, 2011 with clinicaltrials.gov (NCT01410058).

  18. 76 FR 57980 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-19

    ... 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... summary rating of the senior executive's performance, the executive's response, and the higher level...

  19. 75 FR 62501 - Senior Executive Service Performance Review Board: Update

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  20. 76 FR 78257 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  1. Ethics and the ethnography of medical research in Africa

    PubMed Central

    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

  2. 32 CFR 724.402 - Naval Discharge Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false Naval Discharge Review Board. 724.402 Section 724.402 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Principal Elements of the Navy Department Discharge Review System § 724.402 Naval...

  3. 32 CFR 724.402 - Naval Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Naval Discharge Review Board. 724.402 Section 724.402 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Principal Elements of the Navy Department Discharge Review System § 724.402 Naval...

  4. The Technologies of Normalization and Self: Thinking about IRBs and Extrinsic Research Ethics with Foucault

    ERIC Educational Resources Information Center

    Koro-Ljungberg, Mirka; Gemignani, Marco; Brodeur, Cheri Winton; Kmiec, Cheryl

    2007-01-01

    In this article, the authors discuss the technologies of normalization and self in relation to ethics and the problematization of extrinsic research ethics. They argue that institutional review boards (IRBs) and other similar institutional mechanisms promote extrinsic forms of ethics that are exemplified through institutionalized structures such…

  5. 76 FR 76122 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  6. 75 FR 76006 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-07

    ... 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 December 7, 2010. FOR...

  7. 78 FR 67147 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  8. 77 FR 70779 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  9. 32 CFR 581.1 - Army Disability Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... review, at the request of any officer retired or released from active service, without pay, for physical... 32 National Defense 3 2010-07-01 2010-07-01 true Army Disability Review Board. 581.1 Section 581.1 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD...

  10. 76 FR 30646 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-26

    ... 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... ratings of members of the Senior Executive Service (SES) and makes recommendations as to final annual...

  11. 75 FR 1028 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  12. Ethics of reviewing scientific publications.

    PubMed

    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.

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

    PubMed

    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.

  14. 76 FR 3678 - Board Meeting: February 16, 2011-Las Vegas, NV, the U.S. Nuclear Waste Technical Review Board...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-01-20

    ... NUCLEAR WASTE TECHNICAL REVIEW BOARD Board Meeting: February 16, 2011--Las Vegas, NV, the U.S. Nuclear Waste Technical Review Board Will Meet To Discuss DOE Activities Related to Managing Spent Nuclear...-203, Nuclear Waste Policy Amendments Act of 1987, the U.S. Nuclear Waste Technical Review Board will...

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

    PubMed

    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.

  16. 76 FR 24065 - Board Workshop: June 6-7, 2011-Arlington, Virginia; the U.S. Nuclear Waste Technical Review Board...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-29

    ... NUCLEAR WASTE TECHNICAL REVIEW BOARD Board Workshop: June 6-7, 2011--Arlington, Virginia; the U.S. Nuclear Waste Technical Review Board Will Hold a Workshop on Methods for Evaluating Nuclear Waste Streams... 1987, the U.S. Nuclear Waste Technical Review Board will hold a workshop on Monday, June 6, and Tuesday...

  17. 77 FR 60007 - Medical Review Board Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-01

    ...-0362] Medical Review Board Public Meeting AGENCY: Federal Motor Carrier Safety Administration (FMCSA), DOT. ACTION: Notice of Medical Review Board (MRB) public meeting. SUMMARY: The FMCSA announces that... the Federal Motor Carrier Safety Regulation (FMCSR) medical standards. DATES: Meeting Date: The MRB...

  18. Public titles of clinical trials should have ethics review.

    PubMed

    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.

  19. 75 FR 6729 - Senior Executive Service (SES) Performance Review Board; Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

  1. 5 CFR 430.310 - Performance Review Boards (PRBs).

    Code of Federal Regulations, 2010 CFR

    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...

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

    PubMed

    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

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

    PubMed

    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.

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

    PubMed

    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.

  5. 24 CFR 200.1535 - MAP Lender Review Board.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 24 Housing and Urban Development 2 2013-04-01 2013-04-01 false MAP Lender Review Board. 200.1535 Section 200.1535 Housing and Urban Development Regulations Relating to Housing and Urban Development... Lender Quality Assurance Enforcement § 200.1535 MAP Lender Review Board. (a) Authority—(1) Sanctions. The...

  6. 24 CFR 200.1535 - MAP Lender Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 2 2011-04-01 2011-04-01 false MAP Lender Review Board. 200.1535 Section 200.1535 Housing and Urban Development Regulations Relating to Housing and Urban Development... Lender Quality Assurance Enforcement § 200.1535 MAP Lender Review Board. (a) Authority—(1) Sanctions. The...

  7. 24 CFR 200.1535 - MAP Lender Review Board.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 24 Housing and Urban Development 2 2012-04-01 2012-04-01 false MAP Lender Review Board. 200.1535 Section 200.1535 Housing and Urban Development Regulations Relating to Housing and Urban Development... Lender Quality Assurance Enforcement § 200.1535 MAP Lender Review Board. (a) Authority—(1) Sanctions. The...

  8. 24 CFR 200.1535 - MAP Lender Review Board.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 24 Housing and Urban Development 2 2014-04-01 2014-04-01 false MAP Lender Review Board. 200.1535 Section 200.1535 Housing and Urban Development Regulations Relating to Housing and Urban Development... Lender Quality Assurance Enforcement § 200.1535 MAP Lender Review Board. (a) Authority—(1) Sanctions. The...

  9. Ethical issues in research with homeless youths.

    PubMed

    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.

  10. 40 CFR 26.1603 - Operation of the Human Studies Review Board.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 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 2012-07-01 2012-07-01 false Operation of the Human Studies Review...

  11. 40 CFR 26.1603 - Operation of the Human Studies Review Board.

    Code of Federal Regulations, 2010 CFR

    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...

  12. 40 CFR 26.1605 - Operation of the Human Studies Review Board.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 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 2014-07-01 2014-07-01 false Operation of the Human Studies Review...

  13. 40 CFR 26.1605 - Operation of the Human Studies Review Board.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 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 2013-07-01 2013-07-01 false Operation of the Human Studies Review...

  14. 40 CFR 26.1603 - Operation of the Human Studies Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 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 2011-07-01 2011-07-01 false Operation of the Human Studies Review...

  15. 32 CFR 581.2 - Army Discharge Review Board.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... 32 National Defense 3 2013-07-01 2013-07-01 false Army Discharge Review Board. 581.2 Section 581.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD... the efficient overall operation and support of the ADRB panels. (ii) Authenticates the case report and...

  16. 32 CFR 581.2 - Army Discharge Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 3 2011-07-01 2009-07-01 true Army Discharge Review Board. 581.2 Section 581.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD... the efficient overall operation and support of the ADRB panels. (ii) Authenticates the case report and...

  17. 32 CFR 581.2 - Army Discharge Review Board.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 3 2014-07-01 2014-07-01 false Army Discharge Review Board. 581.2 Section 581.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD... the efficient overall operation and support of the ADRB panels. (ii) Authenticates the case report and...

  18. 32 CFR 581.2 - Army Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 3 2010-07-01 2010-07-01 true Army Discharge Review Board. 581.2 Section 581.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD... the efficient overall operation and support of the ADRB panels. (ii) Authenticates the case report and...

  19. 32 CFR 581.2 - Army Discharge Review Board.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 3 2012-07-01 2009-07-01 true Army Discharge Review Board. 581.2 Section 581.2 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD... the efficient overall operation and support of the ADRB panels. (ii) Authenticates the case report and...

  20. 12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 4 2011-01-01 2011-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

  1. 12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 12 Banks and Banking 4 2010-01-01 2010-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

  2. 12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 5 2014-01-01 2014-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

  3. 12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 5 2012-01-01 2012-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

  4. 12 CFR 367.20 - Review and reconsideration of Ethics Counselor decisions.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 5 2013-01-01 2013-01-01 false Review and reconsideration of Ethics Counselor... Review and reconsideration of Ethics Counselor decisions. (a) Review. (1) A suspended and/or excluded contractor may appeal the exclusion decision to the Corporation Ethics Committee. (2) In order to avail...

  5. 32 CFR 581.1 - Army Disability Review Board.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... 32 National Defense 3 2012-07-01 2009-07-01 true Army Disability Review Board. 581.1 Section 581.1 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL REVIEW BOARD... administrative agency created within the Department of the Army under authority of section 302, title I, Act of...

  6. 78 FR 66785 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

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

    PubMed

    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

  9. Ethical dilemmas of recording and reviewing neonatal resuscitation.

    PubMed

    den Boer, Maria C; Houtlosser, Mirjam; van Zanten, Henriëtte Anje; Foglia, Elizabeth E; Engberts, Dirk P; Te Pas, Arjan B

    2018-05-01

    Neonatal resuscitation is provided to approximately 3% of neonates. Adequate ventilation is often the key to successful resuscitation, but this can be difficult to provide. There is increasing evidence that inappropriate respiratory support can have severe consequences. Several neonatal intensive care units have recorded and reviewed neonatal resuscitation procedures for quality assessment, education and research; however, ethical dilemmas sometimes make it difficult to implement this review process. We reviewed the literature on the development of recording and reviewing neonatal resuscitation and have summarised the ethical concerns involved. Recording and reviewing vital physiological parameters and video imaging of neonatal resuscitation in the delivery room is a valuable tool for quality assurance, education and research. Furthermore, it can improve the quality of neonatal resuscitation provided. We observed that ethical dilemmas arise as the review process is operating in several domains of healthcare that all have their specific moral framework with requirements and conditions on issues such as consent, privacy and data storage. These moral requirements and conditions vary due to local circumstances. Further research on the ethical aspects of recording and reviewing is desirable before wider implementation of this technique can be recommended. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

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

    PubMed

    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.

  11. Ethical Challenges and Complexities of Including People with Intellectual Disability as Participants in Research

    ERIC Educational Resources Information Center

    Iacono, Teresa

    2006-01-01

    The aim of this article is to consider the implications for research involving people with intellectual disability--a vulnerable group--of ethics committees' attempts to apply these guidelines. The issue explored is whether committees such as Human Research Ethics Committees (HRECS) and Institutional Review Boards (IRBs) are becoming increasingly…

  12. 32 CFR 865.122 - Summary of statistics for Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 6 2010-07-01 2010-07-01 false Summary of statistics for Discharge Review Board. 865.122 Section 865.122 National Defense Department of Defense (Continued) DEPARTMENT OF THE AIR FORCE... statistics for Discharge Review Board. The Air Force Discharge Review Board shall prepare and provide to the...

  13. 75 FR 62509 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-12

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

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

    PubMed

    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.

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

    PubMed

    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.

  16. Environmental health and justice and the right to research: institutional review board denials of community-based chemical biomonitoring of breast milk.

    PubMed

    Saxton, Dvera I; Brown, Phil; Seguinot-Medina, Samarys; Eckstein, Lorraine; Carpenter, David O; Miller, Pamela; Waghiyi, Vi

    2015-11-25

    Recently, conflicts and challenges have emerged regarding environmental justice and research ethics for some indigenous communities. Alaska Community Action on Toxics (ACAT) responded to community requests for breast milk biomonitoring and conceived the Breast Milk Pilot Study (BMPS). Despite having community support and federal and private funding, the BMPS remains incomplete due to repeated disapprovals by the Alaska Area IRB (Institutional Review Board). In this commentary, we explore the consequences of years of IRB denials, in terms of health inequalities, environmental justice, and research ethics. We highlight the greater significance of this story with respect to research in Alaska Native communities, biomonitoring, and global toxics regulation. We offer suggestions to community-based researchers conducting biomonitoring projects on how to engage with IRBs in order to cultivate reflective, context-based research ethics that better consider the needs and concerns of communities.

  17. Regulations and Ethical Considerations for Astronomy Education Research II: Resources and Worked Examples

    NASA Astrophysics Data System (ADS)

    Brogt, Erik; Dokter, Erin; Antonellis, Jessie; Buxner, Sanlyn

    This article discusses the legal and ethical requirements of human subjects research proposals in astronomy education research. We present an overview of the relevant laws, regulations, and guidelines that inform an Institutional Review Board evaluation of proposed research. We also present examples of potential research projects in astronomy education research and discuss their ethical issues.

  18. Ethical issues in publishing in predatory journals.

    PubMed

    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.

  19. 10 CFR 81.53 - Review by the Board.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... Inventions-Patents and Applications § 81.53 Review by the Board. (a) The Board shall determine the propriety... the decision of the Commission, which conclusion shall constitute the final action of the Commission. ...

  20. 75 FR 67697 - Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-03

    ... DEPARTMENT OF DEFENSE Office of the Secretary Membership of the Performance Review Board AGENCY... appointment of the Office of the Secretary of Defense, Performance Review Board (PRB) members, to include the....S Court of Appeals for the Armed Forces and the following Defense Agencies: Defense Advance Research...

  1. Ethical review of human experimentation in the consumer products industry.

    PubMed

    Steadman, J H

    1998-04-01

    Ethical review of human experimentation in the consumer products industry is important and provides instructive parallels and contrasts with clinical medical research. The procedures used in Unilever NV/plc are described. A central body sets standards for and monitors compliance with ethical review of human studies throughout Unilever. Guidance has been produced on many topics including issues applying generally to human experimentation and more specifically to the consumer products sector. Deficiencies and inconsistencies in the procedures for ethical review and the care of subjects during the conduct of studies have been identified and corrected. Appropriate uniform standards have been achieved across all Unilever operations. All human experimentation in the industry needs adequate ethical review. Although the methods used by individual companies may differ, procedures must ensure uniform high standards across a global industry.

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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

  5. Ethical aspects of tissue engineering: a review.

    PubMed

    de Vries, Rob B M; Oerlemans, Anke; Trommelmans, Leen; Dierickx, Kris; Gordijn, Bert

    2008-12-01

    Tissue engineering (TE) is a promising new field of medical technology. However, like other new technologies, it is not free of ethical challenges. Identifying these ethical questions at an early stage is not only part of science's responsibility toward society, but also in the interest of the field itself. In this review, we map which ethical issues related to TE have already been documented in the scientific literature. The issues that turn out to dominate the debate are the use of human embryonic stem cells and therapeutic cloning. Nevertheless, a variety of other ethical aspects are mentioned, which relate to different phases in the development of the field. In addition, we discuss a number of ethical issues that have not yet been raised in the literature.

  6. Preparing Protocols for Institutional Review Boards.

    ERIC Educational Resources Information Center

    Lyons, Charles M.

    1983-01-01

    Introduces the process by which Institutional Review Boards (IRBs) review proposals for research involving human subjects. Describes the composition of IRBs. Presents the Nuremberg code, the elements of informed consent, the judging criteria for proposals, and a sample protocol format. References newly published regulations governing research with…

  7. Using the American Board of Internal Medicine's "Elements of Professionalism" for undergraduate ethics education.

    PubMed

    Robins, Lynne S; Braddock, Clarence H; Fryer-Edwards, Kelly A

    2002-06-01

    To examine the feasibility of using the taxonomy of professional and unprofessional behaviors presented in the American Board of Internal Medicine's (ABIM's) Project Professionalism to categorize ethical issues that undergraduate medical students perceive to be salient. Beginning second-year medical students at the University of Washington School of Medicine (n = 120) were asked to respond to three open-ended questions about professional standards of conduct and peer evaluation. Two of the authors read and coded the students' responses according to the ABIM's elements of professionalism (altruism, accountability, excellence, duty, honor and integrity, and respect for others) and the challenges to those elements (abuse of power, arrogance, greed, misrepresentation, impairment, lack of conscientiousness, and conflict of interest). Coding disagreements were solved using review and revision of the category definitions. New categories were created for students' responses that described behaviors or issues that were not captured in the ABIM's categories. A total of 114 students responded. The ABIM's professional code was adapted for students and teachers, making it context- and learning-stage-specific. One new category of challenges, conflicts of conscience, was added, and one category (abuse of power) was expanded to include abuse of power/negotiating power asymmetries. Using the ABIM's taxonomy to name professional and unprofessional behaviors was particularly useful for examining undergraduate medical students' perceptions of the ethical climate for learning during the first year of medical school, and it holds promise for research into changes in students' perceptions as they move into clinical experiences. Using the framework, students can build a unified professional knowledge-and-skills base.

  8. Methodological and ethical challenges in studying patients’ perceptions of coercion: a systematic mixed studies review

    PubMed Central

    2014-01-01

    Background Despite improvements in psychiatric inpatient care, patient restrictions in psychiatric hospitals are still in use. Studying perceptions among patients who have been secluded or physically restrained during their hospital stay is challenging. We sought to review the methodological and ethical challenges in qualitative and quantitative studies aiming to describe patients’ perceptions of coercive measures, especially seclusion and physical restraints during their hospital stay. Methods Systematic mixed studies review was the study method. Studies reporting patients’ perceptions of coercive measures, especially seclusion and physical restraints during hospital stay were included. Methodological issues such as study design, data collection and recruitment process, participants, sampling, patient refusal or non-participation, and ethical issues such as informed consent process, and approval were synthesized systematically. Electronic searches of CINALH, MEDLINE, PsychINFO and The Cochrane Library (1976-2012) were carried out. Results Out of 846 initial citations, 32 studies were included, 14 qualitative and 18 quantitative studies. A variety of methodological approaches were used, although descriptive and explorative designs were used in most cases. Data were mainly collected in qualitative studies by interviews (n = 13) or in quantitative studies by self-report questionnaires (n = 12). The recruitment process was explained in 59% (n = 19) of the studies. In most cases convenience sampling was used, yet five studies used randomization. Patient’s refusal or non-participation was reported in 37% (n = 11) of studies. Of all studies, 56% (n = 18) had reported undergone an ethical review process in an official board or committee. Respondents were informed and consent was requested in 69% studies (n = 22). Conclusions The use of different study designs made comparison methodologically challenging. The timing of data collection

  9. Methodological and ethical challenges in studying patients' perceptions of coercion: a systematic mixed studies review.

    PubMed

    Soininen, Päivi; Putkonen, Hanna; Joffe, Grigori; Korkeila, Jyrki; Välimäki, Maritta

    2014-06-04

    Despite improvements in psychiatric inpatient care, patient restrictions in psychiatric hospitals are still in use. Studying perceptions among patients who have been secluded or physically restrained during their hospital stay is challenging. We sought to review the methodological and ethical challenges in qualitative and quantitative studies aiming to describe patients' perceptions of coercive measures, especially seclusion and physical restraints during their hospital stay. Systematic mixed studies review was the study method. Studies reporting patients' perceptions of coercive measures, especially seclusion and physical restraints during hospital stay were included. Methodological issues such as study design, data collection and recruitment process, participants, sampling, patient refusal or non-participation, and ethical issues such as informed consent process, and approval were synthesized systematically. Electronic searches of CINALH, MEDLINE, PsychINFO and The Cochrane Library (1976-2012) were carried out. Out of 846 initial citations, 32 studies were included, 14 qualitative and 18 quantitative studies. A variety of methodological approaches were used, although descriptive and explorative designs were used in most cases. Data were mainly collected in qualitative studies by interviews (n = 13) or in quantitative studies by self-report questionnaires (n = 12). The recruitment process was explained in 59% (n = 19) of the studies. In most cases convenience sampling was used, yet five studies used randomization. Patient's refusal or non-participation was reported in 37% (n = 11) of studies. Of all studies, 56% (n = 18) had reported undergone an ethical review process in an official board or committee. Respondents were informed and consent was requested in 69% studies (n = 22). The use of different study designs made comparison methodologically challenging. The timing of data collection (considering bias and confounding factors) and the

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

    PubMed

    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.

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

    PubMed

    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

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

    ERIC Educational Resources Information Center

    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…

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

    PubMed

    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.

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

    PubMed

    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.

  15. Journal policy on ethics in scientific publication.

    PubMed

    Callaham, Michael L

    2003-01-01

    Medical journals aspire to select, through peer review, the highest quality science, and their reputations depend on the trust of readers, authors, researchers, reviewers, and patients. Almost every aspect of this process involves important ethical principles and decisions, which are seldom explicitly stated and even less often shared with the readership. A comprehensive policy on publication ethics is summarized in this article. A few of the topics addressed are study design; research subject consent; definitions and responsibilities of authorship; declaration of paid writers; types of potential conflicts of interest; management of conflicts of interest on the part of authors, journal reviewers, and members of the editorial board; blinding and confidentiality of peer review; assessment of peer review quality; public identification of degree of peer review of various portions of the journal; criteria for manuscript decisions; management of author appeals; definitions of prior publication; plagiarism; criteria for advertising and relationship between advertising and editorial matter; allegations of misconduct and journal policies for responding to them; and the relationship of the journal to the sponsoring society. Our goal in publishing these policies is to make the guiding ethical principles of this journal accessible to all of our readers and contributors.

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

    PubMed Central

    Tully, Joanna; Ninis, Nelly; Booy, Robert; Viner, Russell

    2000-01-01

    Objective To assess the function of the new system of review by multicentre research ethics committees and to highlight areas where improvement is still needed. Design Prospectively collected data from a multicentre study was examined with respect to the ethics review process. Administrative, financial, and time elements of the review process were audited. Setting A single multicentre research ethics committee and 125 local ethics committees from six regions of England. Main outcome measures Time to reply, time to approval, and number of non-local changes to the application requested. Results Only 40% of local ethics committees considered our study in the manner specified in the 1998 directive. Less than a third of committees replied within the 21 day period stipulated, although committees acting by executive subcommittee replied more quickly than those not acting by executive subcommittee. There was a tendency for executive subcommittees to approve studies in a shorter time. Local ethics committees asked for a large number of non-local changes to the application. The financial cost of applying to multiple ethics committees remains high, mainly because multiple copies of research applications are being requested. Conclusions The new system of approval by multicentre research ethics committee for multicentre studies was introduced to reduce administrative costs, speed up the process of reviews by multiple research ethics committees, and standardise the conclusions of the local research ethics committees. Since its introduction an improvement has been seen, but the system is not yet universally functioning as intended. Ethics review still remains a hindrance to the financial resources and commencement of national studies. We strongly support the structure of review by multicentre research ethics committees but suggest that the system has yet to achieve its aims. PMID:10784541

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

    ERIC Educational Resources Information Center

    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,…

  18. The Legacy of Kenneth B. Clark to the APA: The Board of Social and Ethical Responsibility for Psychology.

    ERIC Educational Resources Information Center

    Pickren, Wade E.; Tomes, Henry

    2002-01-01

    Describes how the American Psychological Association changed in response to social problems and calls for social action, examining events leading to the establishment of the Board of Social and Ethical Responsibility for Psychology in 1972 and highlighting the role of African American psychologist Kenneth B. Clark in those events. (Contains…

  19. 42 CFR 405.2113 - Medical review board.

    Code of Federal Regulations, 2012 CFR

    2012-10-01

    ...-Stage Renal Disease (ESRD) Services § 405.2113 Medical review board. (a) General. The medical review... financial interest (as described in section 1126(a)(1) of the Act). [51 FR 30361, Aug. 26, 1986, as amended...

  20. 42 CFR 405.2113 - Medical review board.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ...-Stage Renal Disease (ESRD) Services § 405.2113 Medical review board. (a) General. The medical review... financial interest (as described in section 1126(a)(1) of the Act). [51 FR 30361, Aug. 26, 1986, as amended...

  1. 42 CFR 405.2113 - Medical review board.

    Code of Federal Regulations, 2013 CFR

    2013-10-01

    ...-Stage Renal Disease (ESRD) Services § 405.2113 Medical review board. (a) General. The medical review... financial interest (as described in section 1126(a)(1) of the Act). [51 FR 30361, Aug. 26, 1986, as amended...

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed Central

    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. PMID:26648756

  5. 20 CFR 405.410 - Selecting claims for Decision Review Board review.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... 20 Employees' Benefits 2 2010-04-01 2010-04-01 false Selecting claims for Decision Review Board review. 405.410 Section 405.410 Employees' Benefits SOCIAL SECURITY ADMINISTRATION ADMINISTRATIVE REVIEW... will not review claims based on the identity of the administrative law judge who decided the claim. (b...

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

    PubMed

    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.

  7. Acute care research: is it ethical?

    PubMed

    Iserson, K V; Mahowald, M B

    1992-07-01

    Research in acute care is a troubling area for Institutional Review Board (IRB) approval and informed consent. Confusion about ethical and legal requirements has hampered research efforts and subsequent patient benefits. Acute care patients are the relatively few critical care patients who have suffered unexpected events that carry a high probability of mortality or severe morbidity unless immediate medical intervention is provided. We argue that acute care research is justified if the usual ethical requirements for research are modified to reflect the uniqueness of the situation. Our recommendations are to: a) use an explicit definition of acute care as distinct from other modes of critical care; b) eliminate the requirement for informed consent (as it is usually understood); and c) require stringent IRB oversight, regarding the unique ethical problems raised by this area of research. We further suggest that IRB oversight includes review of the protocol by a panel of individuals who represent possible enrollees in the proposed study.

  8. 78 FR 63275 - Senior Executive Service Performance Review Boards Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  9. 75 FR 63472 - SES Performance Review Board-Appointment of Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-15

    ... EQUAL EMPLOYMENT OPPORTUNITY COMMISSION SES Performance Review Board--Appointment of Members AGENCY: Equal Employment Opportunity Commission. ACTION: Notice. SUMMARY: Notice is hereby given of the appointment of members to the Performance Review Board of the Equal Employment Opportunity Commission. FOR...

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

    PubMed

    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.

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

    PubMed Central

    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

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

    PubMed

    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.

    PubMed

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

    Code of Federal Regulations, 2010 CFR

    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...

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

    ERIC Educational Resources Information Center

    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…

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

    PubMed Central

    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

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

    PubMed

    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.

  18. 75 FR 68668 - Senior Executive Service; Departmental Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed Central

    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

  2. 77 FR 51523 - Senior Executive Service Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  3. 77 FR 70204 - Senior Executive Service: Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  4. 78 FR 75447 - Senior Executive Service; Departmental Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  5. 78 FR 52995 - Senior Executive Service: Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  6. 76 FR 69798 - Senior Executive Service; Departmental Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    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. 77 FR 9723 - Department of State Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-17

    ... DEPARTMENT OF STATE [Public Notice: 7802] Department of State Performance Review Board Members In accordance with section 4314(c)(4) of 5 United States Code, the Department of State has appointed the following individuals to the Department of State Performance Review Board for Senior [[Page 9724

  9. 76 FR 62893 - Department of State Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-11

    ... DEPARTMENT OF STATE [Public Notice: 7639] Department of State Performance Review Board Members In accordance with section 4314(c)(4) of 5 United States Code, the Department of State has appointed the following individuals to the Department of State Performance Review Board for Senior Executive Service...

  10. Criticism and the Ethics of Negative Reviews

    ERIC Educational Resources Information Center

    Peters, Michael A.

    2014-01-01

    This paper is an attempt to work through my own angst at a negative review of my "Education, Philosophy and Politics," reviewed recently by Ian Stronach for the "British Educational Research Journal," and to provide a therapeutic reading of the ethics of negative reviews. What of "shots in the dark" and should there…

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

    PubMed Central

    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

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

    PubMed

    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.

  13. What ethics for case managers? Literature review and discussion.

    PubMed

    Corvol, Aline; Moutel, Grégoire; Somme, Dominique

    2016-11-01

    Little is known about case managers' ethical issues and professional values. This article presents an overview of ethical issues in case managers' current practice. Findings are examined in the light of nursing ethics, social work ethics and principle-based biomedical ethics. A systematic literature review was performed to identify and analyse empirical studies concerning ethical issues in case management programmes. It was completed by systematic content analysis of case managers' national codes of ethics. Only nine empirical studies were identified, eight of them from North America. The main dilemmas were how to balance system goals against the client's interest and client protection against autonomy. Professional codes of ethics shared important similarities, but offered different responses to these two dilemmas. We discuss the respective roles of professional and organizational ethics. Further lines of research are suggested. © The Author(s) 2015.

  14. 78 FR 55244 - Senior Executive Service Performance Review Board; Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  15. Report of Apollo 204 Review Board

    NASA Technical Reports Server (NTRS)

    1967-01-01

    The Nation's space program requires that man and machine achieve the highest capability to pursue the exploration of space. The Apollo 204 Review Board was charged with the responsibility of reviewing the circumstances surrounding the accident, reporting its findings relating to the cause of the accident, and formulating recommendations so that inherent hazards are reduced to a minimum. The Board is very concerned that its description of the defects in the Apollo Program that led to the condition existing at the time of the Apollo 204 accident will be interpreted as an indictment of the entire manned space flight program and a castigation of the many people associated with that program. This report, rather than presenting a total picture of that program, is concerned with the deficiencies uncovered.

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

    NASA Astrophysics Data System (ADS)

    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.

  17. Factors influencing the effectiveness of research ethics committees.

    PubMed

    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.

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

    PubMed

    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.

  19. 77 FR 65248 - Senior Executive Service; Public Debt Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  20. 78 FR 73586 - Senior Executive Service Performance Review Board (PRB) and Executive Resources Board (ERB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  1. 77 FR 35752 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-14

    ... agency implement a performance appraisal system making senior executives accountable for organizational... DEPARTMENT OF TRANSPORTATION Surface Transportation Board Senior Executive Service Performance... Executive Service Performance Review Board (PRB). FOR FURTHER INFORMATION CONTACT: Paula Chandler, Director...

  2. Institutional Ethical Review and Ethnographic Research Involving Injection Drug Users: A Case Study

    PubMed Central

    Small, Will; Maher, Lisa; Kerr, Thomas

    2014-01-01

    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. PMID:24581074

  3. AGU Launches Web Site for New Scientific Integrity and Professional Ethics Policy

    NASA Astrophysics Data System (ADS)

    Townsend, Randy

    2013-03-01

    AGU's Scientific Integrity and Professional Ethics policy, approved by the AGU Board of Directors and Council in December 2012, is now available online on a new Web site, http://ethics.agu.org. As the Web site states, the policy embodies a "set of guidelines for scientific integrity and professional ethics for the actions of the members and the governance of the Union in its internal activities; in its public persona; and most importantly, in the research and peer review processes of its scientific publications, its communications and outreach, and its scientific meetings."

  4. Innovations in research ethics governance in humanitarian settings.

    PubMed

    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

  5. Forthcoming ethical issues in biological psychiatry.

    PubMed

    Helmchen, Hanfried

    2005-01-01

    Ethical issues in biological psychiatry are framed by (i) progress in the neurosciences, and (ii) a changing socio-cultural context. With regard to forthcoming neurotechniques to modify specifically defined brain functions by pharmacological substances with selective effects, by activating neuroplasticity including neurogenesis, or by implantation of neuronal tissues or computer-brain interfaces, etc., ethical problems will develop (i) at the border between therapy of diseases and enhancement of abilities in healthy people with regard to effects on society (e.g., social justice: equal access, loss of societal diversity) as well as on human value systems (e.g., personality, efforts, conditio humana), and (ii) at the border between the medical system and the wellness market with regard to financing what by whom? Ethical dilemmas in psychiatry develop (i) between the individual's best and the common good (demanded from outside medicine), (ii) among different ethical principles (inside medicine), iii) if solutions are influenced by personal reasons without observing ethical principles. Ethical guidelines are necessary for ethical orientation, but may protect against misconduct only (i) if psychiatrists are educated in ethics and (ii) if psychiatric acting is under continuous debate (by ethical review boards or the public). Thus, if we psychiatrists will become ethically sensitive by reflecting and perhaps solving our current ethical dilemmas we will be prepared to deal with forthcoming ethical issues in biological psychiatry.

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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.

  9. 76 FR 66332 - Appointments to Performance Review Boards for Senior Executive Service

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... NUCLEAR REGULATORY COMMISSION [NRC-2011-0249] Appointments to Performance Review Boards for Senior Executive Service AGENCY: U.S. Nuclear Regulatory Commission. ACTION: Appointment to Performance Review... the following appointments to the NRC Performance Review Boards. The following individuals are...

  10. Ethical issues in mental health

    PubMed Central

    DuBois, James; Bailey-Burch, Brendolyn; Bustillos, Dan; Campbell, Jean; Cottler, Linda; Fisher, Celia; Hadley, Whitney B.; Hoop, Jinger G.; Roberts, Laura; Salter, Erica K.; Sieber, Joan E.; Stevenson, Richard D.

    2012-01-01

    Purpose of review To describe community engaged research (CEnR) and how it may improve the quality of a research study while addressing ethical concerns that communities may have with mental health and substance abuse research. This article includes a review of the literature as well as recommendations from an expert panel convened with funding from the US National Institute of Mental Health. Recent findings CEnR represents a broad spectrum of practices including representation on institutional ethics committees, attitude research with individuals from the study population, engaging community advisory boards, forming research partnerships with community organizations, and including community members as co-investigators. Summary CEnR poses some challenges; for example, it requires funding and training for researchers and community members. However, it offers many benefits to researchers and communities and some form of CEnR is appropriate and feasible in nearly every study involving human participants. PMID:21460643

  11. Designing an Ethics Class.

    ERIC Educational Resources Information Center

    Prager, Richard

    1993-01-01

    Describes a required ethics course designed for juniors and seniors at a small Connecticut boarding school. Students explore the ethics of care and justice, examine ethical assumptions behind the school's disciplinary system, consider a series of dilemmas, and discuss complex topics such as abortion, euthanasia, and racism. A sidebar outlines…

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

    PubMed

    Scherzinger, Gregor; Bobbert, Monika

    2017-01-01

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

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

    PubMed

    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.

  14. Disciplinary supervision following ethics complaints: goals, tasks, and ethical dimensions.

    PubMed

    Thomas, Janet T

    2014-11-01

    Clinical supervision is considered an integral component of the training of psychologists, and most of the professional literature is focused on this type of supervision. But psychologists also may supervise fully credentialed colleagues in other circumstances. One such context occurs when licensing boards mandate supervision as part of a disciplinary order. When supervision is provided in disciplinary cases, there are significant implications for the ethical dimensions of the supervisory relationship and concomitant ethical challenges for supervisors. Not only are the goals, objectives, and supervisory tasks of disciplinary supervision distinct from other types of supervision, but the supervisor's ethical responsibilities also encompass unique dimensions. Competence, informed consent, boundaries, confidentiality, and documentation are examined. Recommendations for reports to licensing boards include a statement of the clinical or ethical problems instigating discipline, description of how these problems have been addressed, and an assessment of the supervisee's current practices and ability to perform competently. © 2014 Wiley Periodicals, Inc.

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

    PubMed

    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

  16. 75 FR 69047 - Senior Executive Service: Membership of Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-10

    ... 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 2010 and 2011 SES Performance Review Boards. The Agency will use this...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    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?

    PubMed

    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. 49 CFR 1182.4 - Board review of the application.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 49 Transportation 8 2010-10-01 2010-10-01 false Board review of the application. 1182.4 Section 1182.4 Transportation Other Regulations Relating to Transportation (Continued) SURFACE TRANSPORTATION BOARD, DEPARTMENT OF TRANSPORTATION RULES OF PRACTICE PURCHASE, MERGER, AND CONTROL OF MOTOR PASSENGER...

  20. Reviews of Functional MRI: The Ethical Dimensions of Methodological Critique

    PubMed Central

    Anderson, James; Mizgalewicz, Ania; Illes, Judy

    2012-01-01

    Neuroimaging studies involving human subjects raise a range of ethics issues. Many of these issues are heightened in the context of neuroimaging research involving persons with mental health disorders. There has been growing interest in these issues among legal scholars, philosophers, social scientists, and as well as neuroimagers over the last decade. Less clear, however, is the extent to which members of the neuroimaging community are engaged with these issues when they undertake their research and report results. In this study, we analyze the peer-reviewed review literature involving fMRI as applied to the study of mental health disorders. Our hypothesis is that, due to the critical orientation of reviews, and the vulnerability of mental health population, the penetrance of neuroethics will be higher in the review literature in this area than it is in the primary fMRI research literature more generally. We find that while authors of reviews do focus a great deal of attention on the methodological limitations of the studies they discussed, contrary to our hypothesis, they do not frame concerns in ethical terms despite their ethical significance. We argue that an ethics lens on such discussion would increase the knowledge-value of this scholarly work. PMID:22952615

  1. Outcomes of Ethics Consultations in Adult ICUs: A Systematic Review and Meta-Analysis.

    PubMed

    Au, Selena S; Couillard, Philippe; Roze des Ordons, Amanda; Fiest, Kirsten M; Lorenzetti, Dianne L; Jette, Nathalie

    2018-05-01

    Clinical ethics consultation as a mechanism for supporting patients, family, and staff during ethically challenging situations has become standard of care. Despite this, there is a lack of consensus about the effectiveness of clinical ethics consultation consultation in the ICU. We performed a systematic review of outcomes associated with clinical ethics consultation within adult ICUs. We searched MEDLINE, PubMed, Cochrane CENTRAL, Embase, PsycINFO, and Cumulative Index to Nursing and Allied Health Literature from 1984 to May 2017. Two reviewers independently screened articles, assessed eligibility, extracted data, and assessed risk of bias using the Cochrane Collaboration Risk of Bias tool and the Newcastle-Ottawa Scale. Pooled estimates of effect were calculated where possible. We screened 3,970 abstracts and reviewed 325 full-text articles of which 16 met all eligibility criteria. We examined changes in processes and outcomes as a result of clinical ethics consultation in the ICU. Categories of outcomes included user perception, clinical decision, or conflict resolution and resource utilization. The use of clinical ethics consultation in the ICU was associated with positive user experience (383/435 found clinical ethics consultation helpful), although stress and disagreement with clinical ethics consultation recommendations was greater in a subset (113/431 surrogates and providers). Consensus for a clinical decision was more frequently achieved with clinical ethics consultation (odds ratio, 4.09; 95% CI, 1.01-16.55; p = 0.05). Clinical ethics consultation was associated with lower resource utilization including significantly decreased ICU length of stay (mean difference, -4.65 d; 95% CI, -8.86 to -0.44; p = 0.03). Our review identified outcome-based assessment as the predominant measure used to report effectiveness of clinical ethics consultation consultations. In particular, clinical ethics consultation decreased ICU length of stay and increased family and

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

    PubMed

    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.

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

    PubMed

    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.

  4. An Empirical Ethics Agenda for Psychiatric Research Involving Prisoners

    PubMed Central

    Christopher, Paul P.; Candilis, Philip J.; Rich, Josiah D.; Lidz, Charles W.

    2012-01-01

    In the past 30 years, the incarcerated population in the United States has more than quadrupled to 2.3 million adults. With an alarmingly high prevalence of mental illness, substance use, and other serious health conditions compounding their curtailed autonomy, prisoners constitute perhaps the nation’s most disadvantaged group. Scientifically rigorous research involving prisoners holds the potential to inform and enlighten correctional policy and to improve their treatment. At the same time, prisoner research presents significant ethical challenges to investigators and institutional review boards (IRBs) alike, by subjecting participants to conditions that potentially undermine the validity of their informed consent. In 2006, the Institute of Medicine Committee on Ethical Considerations for Revisions to the Department of Health and Human Services (DHHS) Regulations for Protection of Prisoners Involved in Research recommended both further protections and a more permissive approach to research review that would allow inmates greater access to potentially beneficial research. These recommendations have sparked renewed debate about the ethical trade-offs inherent to prisoner research. In this article, the authors review the major justifications for research with prisoner subjects and the associated ethical concerns, and argue that the field of empirical ethics has much to offer to the debate. They then propose a framework for prioritizing future empirical ethics inquiry on this understudied topic. PMID:25309805

  5. 76 FR 69797 - Senior Executive Service Departmental Offices Performance Review Board.

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

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

    PubMed

    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.

  8. Strategies for medical advisory boards and licensing review.

    DOT National Transportation Integrated Search

    2005-07-01

    The objectives of this project were: (1) to document the medical review practices of Medical Advisory : Boards (MABs) and other medical review units within the 51 driver-licensing agencies in the United States : with respect to determining fitness to...

  9. Controversies in nursing ethics: a historical review.

    PubMed

    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.

  10. A Primer on Research Ethics in the Field of Gifted Education

    ERIC Educational Resources Information Center

    Moon, Tonya R.

    2011-01-01

    Most organizations (e.g., institutions of higher education, K-12 school systems) that engage in research with human subjects have institutional review boards (IRBs; also known as research committees) responsible for the oversight of research activities to ensure the ethical treatment of participants. Professional societies such as American…

  11. Ethics and regulation in organ procurement research.

    PubMed

    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.

  12. Philosophy of organ donation: Review of ethical facets

    PubMed Central

    Dalal, Aparna R

    2015-01-01

    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. PMID:26131406

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

    PubMed

    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.

  14. 77 FR 64794 - Membership of the Economic Development Administration Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-23

    ... DEPARTMENT OF COMMERCE Economic Development Administration Membership of the Economic Development Administration Performance Review Board AGENCY: Economic Development Administration, Department of Commerce. ACTION: Notice of Membership on the Economic Development Administration's Performance Review Board...

  15. 75 FR 63813 - Membership of the Economic Development Administration Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-10-18

    ... DEPARTMENT OF COMMERCE Economic Development Administration Membership of the Economic Development Administration Performance Review Board AGENCY: Economic Development Administration, Department of Commerce. ACTION: Notice of membership on the Economic Development Administration's Performance Review Board...

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

    PubMed

    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.

  17. In-home monitoring of persons with dementia: ethical guidelines for technology research and development.

    PubMed

    Mahoney, Diane F; Purtilo, Ruth B; Webbe, Frank M; Alwan, Majd; Bharucha, Ashok J; Adlam, Tim D; Jimison, Holly B; Turner, Beverly; Becker, S Ann

    2007-07-01

    Innovative technologies are rapidly emerging that offer caregivers the support and means to assist older adults with cognitive impairment to continue living "at home." Technology research and development efforts applied to older adults with dementia invoke special grant review and institutional review board concerns, to ensure not only safe but also ethically appropriate interventions. Evidence is emerging, however, that tensions are growing between innovators and reviewers. Reviewers with antitechnology biases are in a position to stifle needed innovation. Technology developers who fail to understand the clinical and caregiving aspects of dementia may design applications that are not in alignment with users' capabilities. To bridge this divide, we offer an analysis of the ethical issues surrounding home monitoring, a model framework, and ethical guidelines for technology research and development for persons with Alzheimer's disease and their caregivers.

  18. 32 CFR 724.810 - Availability of Naval Discharge Review Board documents for public inspection and copying.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 32 National Defense 5 2011-07-01 2011-07-01 false Availability of Naval Discharge Review Board... (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Procedures of Naval Discharge Review Board § 724.810 Availability of Naval Discharge Review Board documents for public inspection and...

  19. 32 CFR 724.810 - Availability of Naval Discharge Review Board documents for public inspection and copying.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... 32 National Defense 5 2010-07-01 2010-07-01 false Availability of Naval Discharge Review Board... (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Procedures of Naval Discharge Review Board § 724.810 Availability of Naval Discharge Review Board documents for public inspection and...

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

    PubMed

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

    2013-04-01

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

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

    PubMed

    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.

  2. Health policy and systems research: towards a better understanding and review of ethical issues.

    PubMed

    Luyckx, Valerie Ann; Biller-Andorno, Nikola; Saxena, Abha; Tran, Nhan T

    2017-01-01

    Given the focus on health systems in the post-millennium development goal era and moving towards the sustainable development goals, there is a compelling need for a common framework for health policy and systems research ethics to guide researchers and facilitate review by research ethics committees. A consultation of global health policy and systems research and ethics experts was convened to identify ethical considerations relevant to health policy and systems research based on existing knowledge and to identify knowledge gaps through a scoping review and further expert deliberation. Health policy and systems research is highly complex and, in the absence of guidance documents, there is significant variability in ethics review. Although fundamental ethical principles pertain to both traditional clinical research and health policy and systems research, the application of these principles requires a comprehensive understanding of the nature of health policy and systems research with its distinct challenges. Such awareness must be raised among researchers and research ethics committees. Current research ethics committees lack familiarity with health policy and systems research and because health policy and systems research is conducted in real-world contexts, committees often have difficulties in determining whether a project is indeed research and/or requires ethical review. Given the strong current focus on health policy and systems research to rapidly improve health and health systems functioning globally, greater engagement and dialogue around the ethical concerns is required to optimise research review and research conduct in this rapidly evolving field.

  3. Health policy and systems research: towards a better understanding and review of ethical issues

    PubMed Central

    Biller-Andorno, Nikola; Saxena, Abha; Tran, Nhan T

    2017-01-01

    Given the focus on health systems in the post-millennium development goal era and moving towards the sustainable development goals, there is a compelling need for a common framework for health policy and systems research ethics to guide researchers and facilitate review by research ethics committees. A consultation of global health policy and systems research and ethics experts was convened to identify ethical considerations relevant to health policy and systems research based on existing knowledge and to identify knowledge gaps through a scoping review and further expert deliberation. Health policy and systems research is highly complex and, in the absence of guidance documents, there is significant variability in ethics review. Although fundamental ethical principles pertain to both traditional clinical research and health policy and systems research, the application of these principles requires a comprehensive understanding of the nature of health policy and systems research with its distinct challenges. Such awareness must be raised among researchers and research ethics committees. Current research ethics committees lack familiarity with health policy and systems research and because health policy and systems research is conducted in real-world contexts, committees often have difficulties in determining whether a project is indeed research and/or requires ethical review. Given the strong current focus on health policy and systems research to rapidly improve health and health systems functioning globally, greater engagement and dialogue around the ethical concerns is required to optimise research review and research conduct in this rapidly evolving field. PMID:29225934

  4. 77 FR 69591 - SES Performance Review Board; Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-11-20

    ... member of a performance review board (PRB) shall be published in the Federal Register. The following... E. Lennon, Chief of Staff, International Broadcasting Bureau; Kelu Chao, Director of Performance Review, International Broadcasting Bureau; and Mark L. Prahl, Associate Director for Operations, Voice of...

  5. 32 CFR 1651.4 - Review by district appeal board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... personal appearance and such summary shall be placed in the registrant's file. (n) A district appeal board... registrant's file; and (2) Oral statements by the registrant during the registrant's personal appearance; and... compensated employee authorized to perform the administrative duties of the board shall review the file to...

  6. Towards a balanced approach to identifying conflicts of interest faced by institutional review boards.

    PubMed

    Kaur, Sharon; Balan, Sujata

    2015-10-01

    The welfare and protection of human subjects is critical to the integrity of clinical investigation and research. Institutional review boards (IRBs) were thus set up to be impartial reviewers of research protocols in clinical research. Their main role is to stand between the investigator and her human subjects in order to ensure that the welfare of human subjects are protected. While there is much literature on the conflicts of interest (CIs) faced by investigators and researchers in clinical investigations, an area that is less explored is CIs that may affect members of IRBs during the institutional ethics review of clinical investigations. This article examines the notion of CIs in clinical research and attempts to develop a framework for a clearer and more balanced approach to identifying CIs that may influence members of IRBs and impede their independence. It will also apply the proposed framework to demonstrate how IRBs possess, or at least may appear to possess, forms of financial CIs and non-financial CIs. The proper identification and management of these CIs is critical to preserving the integrity of clinical investigations and achieving the primary aim of human subjects protection.

  7. Ethical Issues for an Editorial Board: "Kairaranga"

    ERIC Educational Resources Information Center

    Clark, John

    2008-01-01

    With academic journals, we think of the ethical aspects of the research contained in the articles rather than with the journal itself. However, journal editing has its own set of ethical concerns, which this article addresses. One is ensuring that the anonymity of institutions and participants, in research and the reporting of practice, is…

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

    PubMed Central

    Coleman, Carl H; Bouësseau, Marie-Charlotte

    2008-01-01

    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 studies? Second, does the

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

    PubMed Central

    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

  10. 77 FR 60116 - Human Studies Review Board; Notification of a Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This... and ethics issues under discussion, it is not our intent to permit organizations to expand the time..., information, and recommendations to the EPA on issues related to scientific and ethical aspects of human...

  11. 76 FR 80938 - Human Studies Review Board; Notification of a Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-27

    ... Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This public... of oral comments on the science and ethics issues under discussion, it is not our intent to permit... related to scientific and ethical aspects of human subjects research. The major objectives of the HSRB are...

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

    PubMed

    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.

  13. 78 FR 55064 - First Responder Network Authority Board Special Review Committee Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-09

    ... Network Authority Board Special Review Committee Meeting AGENCY: National Telecommunications and... Responder Network Authority Special Review Committee. SUMMARY: The First Responder Network Authority (First... nationwide, interoperable public safety broadband network. The FirstNet Board is responsible for making...

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

    PubMed

    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.

  15. Ethical publishing in intensive care medicine: A narrative review

    PubMed Central

    Wiedermann, Christian J

    2016-01-01

    Ethical standards in the context of scientific publications are increasingly gaining attention. A narrative review of the literature concerning publication ethics was conducted as found in PubMed, Google Scholar, relevant news articles, position papers, websites and other sources. The Committee on Publication Ethics has produced guidelines and schedules for the handling of problem situations that have been adopted by professional journals and publishers worldwide as guidelines to authors. The defined requirements go beyond the disclosure of conflicts of interest or the prior registration of clinical trials. Recommendations to authors, editors and publishers of journals and research institutions were formulated with regard to issues of authorship, double publications, plagiarism, and conflicts of interest, with special attention being paid to unethical research behavior and data falsification. This narrative review focusses on ethical publishing in intensive care medicine. As scientific misconduct with data falsification damage patients and society, especially if fraudulent studies are considered important or favor certain therapies and downplay their side effects, it is important to ensure that only studies are published that have been carried out with highest integrity according to predefined criteria. For that also the peer review process has to be conducted in accordance with the highest possible scientific standards and making use of available modern information technology. The review provides the current state of recommendations that are considered to be most relevant particularly in the field of intensive care medicine. PMID:27652208

  16. Ethical aspects on rare diseases.

    PubMed

    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.

  17. 77 FR 11555 - Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-27

    ... either http://www.regulations.gov or http://www.fda.gov/ScienceResearch/SpecialTopics/RunningClinical...] Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors: Institutional Review Board Continuing Review After Clinical Investigation Approval; Availability AGENCY: Food and Drug Administration...

  18. 78 FR 57383 - Human Studies Review Board; Notification of a Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-09-18

    ... advise the Agency on the EPA scientific and ethical reviews of research with human subjects. DATES: This... organization. While it is our intent to hear a full range of oral comments on the science and ethics issues..., information, and recommendations to the EPA on issues related to scientific and ethical aspects of human...

  19. Background Material for the Human Studies Review Board's Review of Ezratty 2014

    EPA Pesticide Factsheets

    Journal article and details of EPA's science and ethics reviews of the study by Ezratty et al. from 2014: Repeated Nitrogen Dioxide Exposures and Eosinophilic Airway Inflammation in Asthmatics: A Randomized Crossover Study.

  20. 76 FR 26707 - Appointments to Performance Review Board for Senior Executive Service

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-05-09

    ... Review Board for Senior Executive Service AGENCY: Committee for Purchase From People Who Are Blind or Severely Disabled. ACTION: Appointment of Performance Review Board for Senior Executive Service. SUMMARY... appointing and awarding authorities on performance appraisal ratings and performance awards for Senior...

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

    PubMed

    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.

  2. Ethical Issues in Research Involving Participants With Opioid Use Disorder.

    PubMed

    Anderson, Emily; McNair, Lindsay

    2018-05-01

    In the current epidemic of opioid use disorders, there is both a scientific and ethical imperative to develop effective medical and behavioral treatments for opioid addiction. Research in subject populations with active and ongoing drug addictions bring unique ethical considerations and challenges. Sponsors, researchers, and institutional review board (IRB) members should be familiar with these unique ethical and medical issues as they design, review, and conduct research planned for this population. Issues include those of informed consent and decision-making capacity of research participants, compensation for participation and concerns about undue inducement, forces that threaten the voluntary nature of research participation including the scarcity of available drug treatment programs, and ensuring that participants are aware of and understand risks that may continue after research participation such as increased risk of overdose after research-mandated drug abstinence. This manuscript discusses the current thinking on these issues.

  3. Ethical Issues and Practical Challenges in Suicide Research.

    PubMed

    Hom, Melanie A; Podlogar, Matthew C; Stanley, Ian H; Joiner, Thomas E

    2017-03-01

    Research with human subjects represents a critical avenue for suicide prevention efforts; however, such research is not without its ethical and practical challenges. Specifically, given the nature of research with individuals at elevated risk for suicide (e.g., increased concerns regarding participant safety, adverse events, liability, difficulties often arise during the institutional review board (IRB) evaluation and approval process. This paper aims to discuss IRB-related issues associated with suicide prevention research, including researcher and IRB panel member responsibilities, suicide risk assessment and management ethics and procedures, informed consent considerations, preparation of study protocols, and education and training. Points to consider and components to potentially include in an IRB application for suicide-related research are additionally provided. Literature relevant to ethics in suicide research and suicide risk assessment and management was reviewed and synthesized. Suicide research can be conducted in accordance with ethical principles while also furthering the science of suicide prevention. Despite the challenging nature of suicide prevention research, empirically informed solutions exist to address difficulties that may emerge in interfacing with IRBs. There remain areas for improvement in the IRB approval process that warrant further investigation and work.

  4. Variations in institutional review board processes and consent requirements for trauma research: an EAST multicenter survey

    PubMed Central

    Nahmias, Jeffry; Brakenridge, Scott; Jawa, Randeep S; Holena, Daniel N; Agapian, John Varujan; Bruns, Brandon; Chestovich, Paul J; Chung, Bruce; Nguyen, Jonathan; Schulman, Carl I; Staudenmayer, Kristan; Dixon, Rachel; Smith, Jason W; Bernard, Andrew C; Pascual, Jose L

    2018-01-01

    Oversight of human subject research has evolved considerably since its inception. However, previous studies identified a lack of consistency of institutional review board (IRB) determination for the type of review required and whether informed consent is necessary, especially for prospective observational studies, which pose minimal risk of harm. We hypothesized that there is significant inter-institution variation in IRB requirements for the type of review and necessity of informed consent, especially for prospective observational trials without blood/tissue utilization. We also sought to describe investigators’ and IRB members’ attitudes toward the type of review and need for consent. Eastern Association for the Surgery of Trauma (EAST) and IRB members were sent an electronic survey on IRB review and informed consent requirement. We performed descriptive analyses as well as Fisher’s exact test to determine differences between EAST and IRB members’ responses. The response rate for EAST members from 113 institutions was 13.5%, whereas a convenience sample of IRB members from 14 institutions had a response rate of 64.4%. Requirement for full IRB review for retrospective studies using patient identifiers was reported by zero IRB member compared with 13.1% of EAST members (p=0.05). Regarding prospective observational trials without blood/tissue collection, 48.1% of EAST members reported their institutions required a full IRB review compared with 9.5% of IRB members (p=0.01). For prospective observational trials with blood/tissue collection, 80% of EAST members indicated requirement to submit a full IRB review compared with only 13.6% of IRB members (p<0.001). Most EAST members (78.6%) stated that informed consent is not ethically necessary in prospective observational trials without blood/tissue collection, whereas most IRB members thought that informed consent was ethically necessary (63.6%, p<0.001). There is significant variation in perception and practice

  5. 32 CFR 724.304 - Responsibility for Department of the Navy support of the Naval Discharge Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... support of the Naval Discharge Review Board. 724.304 Section 724.304 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Director, Secretary of the Navy Council of Review Boards and President Naval Discharge Review Board; Responsibilities in...

  6. 32 CFR 724.304 - Responsibility for Department of the Navy support of the Naval Discharge Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... support of the Naval Discharge Review Board. 724.304 Section 724.304 National Defense Department of Defense (Continued) DEPARTMENT OF THE NAVY PERSONNEL NAVAL DISCHARGE REVIEW BOARD Director, Secretary of the Navy Council of Review Boards and President Naval Discharge Review Board; Responsibilities in...

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

    PubMed

    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

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

    PubMed

    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

  9. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 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...

  10. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Code of Federal Regulations, 2010 CFR

    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...

  11. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ... 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...

  12. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ... 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...

  13. 24 CFR 4.34 - Review of Inspector General's report by the Ethics Law Division.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ... 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...

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

    PubMed

    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.

  15. 77 FR 65552 - SES Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-29

    ... GENERAL SERVICES ADMINISTRATION [Notice-CPO-2012-01; Docket 2012-0002; Sequence 21] 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 Senior Executive Service...

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

    PubMed

    Hall, Savannah R; Crifasi, Kristen A; Marinelli, Christina M; Yuen, Hon K

    2016-01-01

    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. 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. 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. 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.

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

    PubMed

    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.

  18. 75 FR 14214 - Senior Executive Service Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  19. 78 FR 5516 - Senior Executive Service Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  20. 76 FR 39926 - Senior Executive Service Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  1. 76 FR 81998 - Senior Executive Service Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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

  5. Regulations and Ethical Considerations for Astronomy Education Research II: Resources and Worked Examples

    ERIC Educational Resources Information Center

    Brogt, Erik; Dokter, Erin; Antonellis, Jessie; Buxner, Sanlyn

    2008-01-01

    This article discusses the legal and ethical requirements of human subjects research proposals in astronomy education research. We present an overview of the relevant laws, regulations, and guidelines that inform an Institutional Review Board evaluation of proposed research. We also present examples of potential research projects in astronomy…

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

    PubMed

    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.

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

    PubMed

    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

  8. 76 FR 17121 - Human Studies Review Board (HSRB); Notification of a Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-03-28

    ... public meeting of the HSRB to advise the Agency on EPA's scientific and ethical reviews of research with... and ethics issues under discussion, it is not our intent to permit organizations to expand the time... provides advice, information, and recommendations to EPA on issues related to scientific and ethical...

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

    PubMed

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

    2016-01-01

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

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

    PubMed Central

    Hunt, Matthew; Tansey, Catherine M.

    2016-01-01

    Background 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. Methods 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. Results 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. Conclusion 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

  11. Data Requirements Review Boards and Their Importance

    DTIC Science & Technology

    2016-02-01

    data: technical data, which are recorded technical or scientific information (not including computer software), and contractual or financial and...navy.mil. References for This Article and Other Useful Sources NAVAIRINST 4200.21E—Naval Air SystemsCommand Data Requirements Review Board DoD

  12. The conceptual and practical ethical dilemmas of using health discussion board posts as research data.

    PubMed

    Bond, Carol S; Ahmed, Osman Hassan; Hind, Martin; Thomas, Bronwen; Hewitt-Taylor, Jaqui

    2013-06-07

    Increasing numbers of people living with a long-term health condition are putting personal health information online, including on discussion boards. Many discussion boards contain material of potential use to researchers; however, it is unclear how this information can and should be used by researchers. To date there has been no evaluation of the views of those individuals sharing health information online regarding the use of their shared information for research purposes. To explore the views of contributors to online diabetes discussion boards with regards to if (and how) they feel their contributions to boards should be used by health researchers. A qualitative approach was employed using online semistructured asynchronous (email) interviews. Interpretative description methodology was used to assess the interview transcripts, and quotations were extracted and anonymized to support each theme. 26 interviews were carried out. Participants agreed that forum posts are in the public domain and that aggregated information could be freely used by researchers. This was agreed to be a good way of ensuring that the view of people living with diabetes is being heard in research. There was no consensus on the need for permission to use individual information, such as quotations, with some people happy for this to be freely used and others feeling that permission is necessary. Participants acknowledged the dichotomy of having placed information into the public domain in an unrestricted way, with some interviewees also wanting to retain control of its use. The Internet is a new research location, and rather than trying to apply traditional ethical norms to this new genre, a new modus operandi is required. The authors propose introducing new norms for presenting research carried out with online discussion boards.

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

    PubMed

    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.

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

    PubMed

    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

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

    PubMed Central

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

    2016-01-01

    ABSTRACT Background: 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. Aims: 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. Method: 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. Results: 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. Conclusion: 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

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

    PubMed

    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.

  17. Expediting the Institutional Review Board Process for Exercise Protocols

    ERIC Educational Resources Information Center

    Macfarlane, Pamela A.; Looney, Marilyn A.

    2011-01-01

    All researchers who use human participants in their study must obtain permission from their appropriate Institutional Review Board (IRB). Once the IRB application enters the review process, a decision is made regarding the type of review it should receive: Level I administrative (exempt), Level II subcommittee (expedited), or Level III full board…

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

    PubMed

    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.

  19. Research Ethics Review: Identifying Public Policy and Program Gaps

    PubMed Central

    Strosberg, Martin A.; Gefenas, Eugenijus; Famenka, Andrei

    2014-01-01

    We present an analytical frame-work for use by fellows of the Fogarty International Center–sponsored Advanced Certificate Program in Research Ethics for Central and Eastern Europe to identify gaps in the public policies establishing research ethics review systems that impede them from doing their job of protecting human research subjects. The framework, illustrated by examples from post-Communist countries, employs a logic model based on the public policy and public management literature. This paper is part of a collection of papers analyzing the Fogarty International Center’s International Research Ethics Education and Curriculum program. PMID:24782068

  20. 76 FR 63351 - Senior Executive Service; Financial Management Service Performance Review Board (PRB)

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  1. 77 FR 60177 - Senior Executive Service; Financial Management Service Performance Review Board (PRB)

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  2. 28 CFR 512.13 - Institutional Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... concerns and evaluate objectively a research proposal's impact on, and relevance to, inmates and to the... interest exists for the BRRB chairperson on a particular research proposal, the Assistant Director... ADMINISTRATION RESEARCH Research § 512.13 Institutional Review Board. (a) The Bureau of Prisons' central...

  3. 28 CFR 512.13 - Institutional Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... concerns and evaluate objectively a research proposal's impact on, and relevance to, inmates and to the... interest exists for the BRRB chairperson on a particular research proposal, the Assistant Director... ADMINISTRATION RESEARCH Research § 512.13 Institutional Review Board. (a) The Bureau of Prisons' central...

  4. 76 FR 60473 - Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-29

    ... DEPARTMENT OF DEFENSE Office of the Secretary Membership of the Performance Review Board AGENCY...: This notice announces the appointment of the Department of Defense, Fourth Estate, Performance Review... the Armed Forces and the following Defense Agencies: Defense Advance Research Projects Agency, Defense...

  5. 42 CFR 34.8 - Reexamination; convening of review boards; expert witnesses; reports.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 1 2010-10-01 2010-10-01 false Reexamination; convening of review boards; expert witnesses; reports. 34.8 Section 34.8 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS MEDICAL EXAMINATION OF ALIENS § 34.8 Reexamination; convening of review boards; expert witnesses; reports...

  6. 42 CFR 34.8 - Reexamination; convening of review boards; expert witnesses; reports.

    Code of Federal Regulations, 2014 CFR

    2014-10-01

    ... 42 Public Health 1 2014-10-01 2014-10-01 false Reexamination; convening of review boards; expert witnesses; reports. 34.8 Section 34.8 Public Health PUBLIC HEALTH SERVICE, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICAL CARE AND EXAMINATIONS MEDICAL EXAMINATION OF ALIENS § 34.8 Reexamination; convening of review boards; expert witnesses; reports...

  7. 36 CFR 1275.46 - Segregation and review; Senior Archival Panel; Presidential Materials Review Board.

    Code of Federal Regulations, 2011 CFR

    2011-07-01

    ... 36 Parks, Forests, and Public Property 3 2011-07-01 2011-07-01 false Segregation and review; Senior Archival Panel; Presidential Materials Review Board. 1275.46 Section 1275.46 Parks, Forests, and... Access by the Public § 1275.46 Segregation and review; Senior Archival Panel; Presidential Materials...

  8. 76 FR 58277 - Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-20

    .... Cantrell, Patrick H. Conway, Kathleen M. Crosby, John Czajkowski, Cheryl R. Dammons, Michelle S. Davis... DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members Title 5, U.S.C. Section... of Senior Executive Service members of the Department of Health and Human Services. Joel S. Ario...

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

    PubMed

    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.

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

    PubMed Central

    Allikmets, Silvia; Knights, Felicity

    2015-01-01

    Objectives This study explores the literature in establishing the value of undergraduate peer-based healthcare ethics teaching as an educational methodology. Methods 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. Results 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. Conclusions 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. PMID:26668050

  11. One Chairperson's Experience of Ethical Review: Balancing Principle, Convention, Relationship and Risk in Educational Research

    ERIC Educational Resources Information Center

    O'Neill, John

    2010-01-01

    The author's experience of ethical review over six years as an academic member and chairperson of a university human ethics committee has been largely positive and educative. The account brings together archival records and personal experience to create a "transactive" account of the practical experience of doing ethical review in one…

  12. Ethics: An Educational Imperative

    ERIC Educational Resources Information Center

    Davis, Gary

    2004-01-01

    Citing scandals in accounting, law, banking, securities and corporations, Candace de Russy, a member of the State University of New York Board of Trustees recently urged college boards to "make ethics a living tradition, a day-to-day reality throughout higher education." If colleges prepare bankers, lawyers, accountants and brokers, de…

  13. Canadian Research Ethics Board Leadership Attitudes to the Return of Genetic Research Results to Individuals and their Families

    PubMed Central

    Fernandez, Conrad V.; O'Rourke, P. Pearle; Beskow, Laura M.

    2015-01-01

    Précis Genomic research may uncover results that have direct actionable benefit to the individual. An emerging debate is the degree to which researchers may have responsibility to offer results to the biological relatives of the research participant. In a companion study to one carried out in the United States, we describe the attitudes of Canadian Research Ethics Board (REB) chairs to this issue and their opinions as to the role of the REB in developing related policy. PMID:26479560

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

    PubMed Central

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

    2017-01-01

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

  15. 42 CFR 405.2113 - Medical review board.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... 42 Public Health 2 2011-10-01 2011-10-01 false Medical review board. 405.2113 Section 405.2113 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Conditions for Coverage of Suppliers of End...

  16. 42 CFR 405.2113 - Medical review board.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 2 2010-10-01 2010-10-01 false Medical review board. 405.2113 Section 405.2113 Public Health CENTERS FOR MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES MEDICARE PROGRAM FEDERAL HEALTH INSURANCE FOR THE AGED AND DISABLED Conditions for Coverage of Suppliers of End...

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

    PubMed

    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.

  18. Back to Basics: Training Student Funding Boards.

    ERIC Educational Resources Information Center

    Cufaude, Jeff

    1988-01-01

    The allocation of student activities fees is one of the primary roles of student associations on most college campuses. Student government and fee board organization models, organizational issues, training board members, and framework for ethical communication are discussed. (MLW)

  19. Time Required for Institutional Review Board Review at One Veterans Affairs Medical Center

    PubMed Central

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

    2015-01-01

    IMPORTANCE 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. OBJECTIVE To measure the overall and incremental process times for IRB review as a process of quality improvement. DESIGN, SETTING, AND PARTICIPANTS 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. MAIN OUTCOMES AND MEASURES Calendar days from initial submission to final approval of research protocols. RESULTS 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. CONCLUSIONS AND RELEVANCE 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

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

    PubMed

    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.

  1. 77 FR 61755 - Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-11

    ... DEPARTMENT OF HEALTH AND HUMAN SERVICES Performance Review Board Members Title 5 U.S.C. 4314(c)(4) of the Civil Service Reform Act of 1978, Public Law 95-454, requires that the appointment of... JULIET COHEN GARY CONNOR SUZI COX VIRGINIA DANIEL KATHERINE DEL VECCHIO PAOLO DELPHIN-RITTMON MIRIAM...

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

    PubMed

    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

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

    PubMed Central

    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

  4. Ethical Guidance for Disaster Response, Specifically Around Crisis Standards of Care: A Systematic Review.

    PubMed

    Leider, Jonathon P; DeBruin, Debra; Reynolds, Nicole; Koch, Angelica; Seaberg, Judy

    2017-09-01

    Terrorism, disease outbreaks, and other natural disasters and mass casualty events have pushed health care and public health systems to identify and refine emergency preparedness protocols for disaster response. Ethical guidance, alongside legal and medical frameworks, are increasingly common components of disaster response plans. To systematically review the prevalence and content of ethical guidance offered for disaster response, specifically around crisis standards of care (CSCs). We systematically indexed academic literature from PubMed, Google Scholar, and ISI Web of Science from 2012 to 2016. We searched for peer-reviewed articles that substantively engaged in discussion of ethical guidance for CSCs. Researchers screened potential articles for identification and discussion of ethical issues in CSC planning. We categorized and cataloged ethical concepts and principles. Of 580 peer-reviewed articles mentioning ethics and CSCs or disaster planning, 38 (6%) met selection criteria. The systematic review of the CSC ethics literature since 2012 showed that authors were primarily focused on the ethical justifications for CSC (n = 20) as well as a need for ethics guidelines for implementing CSCs; the ethical justifications for triage (n = 19), both as to which criteria to use and the appropriate processes by which to employ triage; and international issues (n = 17). In addition to these areas of focus, the scholarly literature included discussion of a number of other ethical issues, including duty to care (n = 11), concepts of a duty to plan (n = 8), utilitarianism (n = 5), moral distress (n = 4), professional norms (n = 3), reciprocity (n = 2), allocation criteria (n = 4), equity (n = 4), research ethics (n = 2), duty to steward resources (n = 2), social utility and social worth (n = 2), and a number of others (n = 20). Although public health preparedness efforts have paid increasing attention to CSCs in

  5. 77 FR 60106 - Membership of the National Oceanic and Atmospheric Administration Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-10-02

    ... Administration (NOAA), Department of Commerce (DOC). ACTION: Notice of Membership of the NOAA Performance Review Board. SUMMARY: In accordance with 5 U.S.C. 4314(c)(4), NOAA announces the appointment of members who will serve on the NOAA Performance Review Board (PRB). The NOAA PRB is responsible for reviewing...

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

    PubMed

    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

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

    PubMed

    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

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

    PubMed

    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

  9. School Board Ethics and Effectiveness

    ERIC Educational Resources Information Center

    Feuerstein, Abe

    2009-01-01

    Since the early 1980s, educational policy has increasingly been focused on improving student performance (Conley, 2003, Murphy, 1990). School governance in general, and school boards in particular, have often been viewed as either the means of implementing needed reforms or as roadblocks in their way (Boyd, 2003; Delagardelle, M.; 2008; Howell,…

  10. A plea for pragmatism in clinical research ethics.

    PubMed

    Brendel, David H; Miller, Franklin G

    2008-04-01

    Pragmatism is a distinctive approach to clinical research ethics that can guide bioethicists and members of institutional review boards (IRBs) as they struggle to balance the competing values of promoting medical research and protecting human subjects participating in it. After defining our understanding of pragmatism in the setting of clinical research ethics, we show how a pragmatic approach can provide guidance not only for the day-to-day functioning of the IRB, but also for evaluation of policy standards, such as the one that addresses acceptable risks for healthy children in clinical research trials. We also show how pragmatic considerations might influence the debate about the use of deception in clinical research. Finally, we show how a pragmatic approach, by regarding the promotion of human research and the protection of human subjects as equally important values, helps to break down the false dichotomy between science and ethics in clinical research.

  11. 78 FR 18978 - Human Studies Review Board; Notification of a Public Webinar/Teleconference

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-28

    ... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2013-0115; FRL 9794-8] Human Studies Review Board... Human Studies Review Board (HSRB) to discuss its draft report on the HSRB meeting held January 17, 2013... studies, especially studies on substances regulated by the EPA, or to persons who are, or may be required...

  12. 76 FR 59697 - Human Studies Review Board (HSRB); Notification of a Public Meeting

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-27

    ... report of the completed Carroll-Loye Biological Research, Inc. study No. Mas-003 to evaluate in the field... ENVIRONMENTAL PROTECTION AGENCY [EPA-HQ-ORD-2011-0693; FRL-9472-4] Human Studies Review Board... public meeting of the Human Studies Review Board (HSRB) to advise the Agency on EPA's scientific and...

  13. Teachers' Ethical Dilemmas: What Would You Do?

    ERIC Educational Resources Information Center

    Bucholz, Jessica L.; Keller, Cassandra L.; Brady, Michael P.

    2007-01-01

    Educators will face a variety of ethical and moral dilemmas throughout their teaching careers; however, they do not have a common board that governs its members' ethical behavior. Instead, there are numerous educational organizations that have written their own specific codes for ethical behavior. The Council for Exceptional Children (CEC) has…

  14. 76 FR 37353 - Federal Acquisition Regulation; Submission for OMB Review; Contractor Business Ethics Compliance...

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  15. New AGU scientific integrity and professional ethics policy available for review

    USGS Publications Warehouse

    Gundersen, Linda C.

    2012-01-01

    The AGU Task Force on Scientific Ethics welcomes your review and comments on AGU's new Scientific Integrity and Professional Ethics Policy. The policy has at its heart a code of conduct adopted from the internationally accepted "Singapore Statement," originally created by the Second World Conference on Research Integrity (http://www.singaporestatement.org/), held in 2010. The new policy also encompasses professional and publishing ethics, providing a single source of guidance to AGU members, officers, authors, and editors

  16. Ethical Issues in Using Twitter for Public Health Surveillance and Research: Developing a Taxonomy of Ethical Concepts From the Research Literature

    PubMed Central

    2014-01-01

    Background 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. Objective 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. Methods 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. Results 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

  17. Ethical standards for medical research in the Israeli military - review of the changes in the last decade.

    PubMed

    Hassidim, Ayal; Kayouf, Raeed; Yavnai, Nirit; Panush, Naomi; Dagan, David; Bader, Tarif; Hartal, Michael

    2016-01-01

    The Israel Defense Forces Medical Corps (IDF MC) institutional review board (IRB) is one of approximately 50 IRBs active in Israel. In addition to routine IRB considerations it must also address in its deliberations specific safeguards in place in the IDF to protect research volunteers in the military environment. In this report, we present the characteristics of the IDF IRB, including the unique circumstances that led to a 2008 change in the pre-IRB advisory and preparatory process (APP). We also present quantitative data on the IRB's throughput and outcomes, in order to provide a benchmark for other IRBs. We reviewed all relevant IDF regulations, both historical and current, pertaining to the structure, activity and oversight of the IRB and of medical research conducted in the IDF. Additionally, we analyzed the ethical review process for all research proposals submitted to the IDF APP between January 1, 2013 and December 31, 2015. In 2008 the IDF implemented several major changes which have had a substantial impact on the ethical regulation of military medical research. The period following these changes has seen a rise in the number of research proposals submitted to the IDF IRB annually. During the years 2013-2015, 377 research proposals entered the APP, of which 329 were deemed appropriate for IRB deliberation. Eight study protocols were granted waivers, 19 were rejected, and the remaining 302 were authorized. Overall, 345 of the 377 research proposals submitted (92 %) were ultimately cleared for execution; 310 of 329 proposals (94 %) deliberated by the IRB were authorized. The IRB required protocol revisions for 47 % of the research proposals, one-third of which were revisions directly associated with military-specific ethical precautions. Guided by the principles of protecting personal autonomy in the complex military setting, the IDF has implemented several unique measures aimed at maintaining the highest ethical standards in medical research. By sharing

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

    PubMed

    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.

  19. 42 CFR 498.80 - Right to request Departmental Appeals Board review of Administrative Law Judge's decision or...

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 42 Public Health 5 2010-10-01 2010-10-01 false Right to request Departmental Appeals Board review... MEDICARE & MEDICAID SERVICES, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) STANDARDS AND... Appeals Board Review § 498.80 Right to request Departmental Appeals Board review of Administrative Law...

  20. 75 FR 81287 - Mortgagee Review Board: Administrative Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-12-27

    ...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing--Federal Housing Commissioner, Department of Housing and Urban Development (HUD). ACTION: Notice. SUMMARY: In compliance with Section 202(c... actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees. FOR FURTHER INFORMATION...

  1. 75 FR 3479 - Mortgagee Review Board: Administrative Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-01-21

    ...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing-Federal Housing Commissioner, Department of Housing and Urban Development (HUD). ACTION: Notice. SUMMARY: In compliance with Section 202(c... actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees. FOR FURTHER INFORMATION...

  2. 77 FR 11149 - Mortgagee Review Board: Administrative Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-24

    ...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing--Federal Housing Commissioner, Department of Housing and Urban Development (HUD). ACTION: Notice. SUMMARY: In compliance with Section 202(c... actions taken by HUD's Mortgagee Review Board against HUD-approved mortgagees. FOR FURTHER INFORMATION...

  3. Ethical principles in health research and review process.

    PubMed

    Tangwa, Godfrey B

    2009-11-01

    In this paper I want to reflect on the fundamental ethical principles and their application in different particular contexts, especially in health research and the ethics review process. Four fundamental ethical principles have been identified and widely discussed in bioethical literature. These principles namely are: autonomy or respect for others, beneficence, non-maleficence and justice. These principles have cross-cultural validity, relevance and applicability. Every real-life situation and every concrete particular case in which ethical decision-making is called-for is unique and different from all others; but the same fundamental ethical principles are relevant and used in addressing all such cases and situations. Very often ethical problems will present themselves in the form of dilemmas and it is then necessary to use the same fundamental principles to analyze the situations, to argue persuasively and cogently with competence for the best options or choices in such situations. The issues I will be dealing with in this paper are necessarily more abstract and theoretical, but we will be discussing them from a very practical viewpoint and impulse, with a view to application in concrete real-life situations. The paper ends with some sample practical examples of cases that the reader can use to test his/her grasp of the principles, how to apply them, how to balance them in differing situations and contexts and how to adjudicate between them when they seem to be in conflict.

  4. An Examination of Accounting Majors' Ethical Decisions before and after an Ethics Course Requirement

    ERIC Educational Resources Information Center

    Rogers, Violet; Smith, Aileen

    2008-01-01

    The increased focus on ethical decision making in the accounting profession has resulted in greater attention being paid to the education of future accountants. Texas is one of the states that requires a State Board approved university course in Accounting Ethics to be on the transcript of prospective CPA candidates. This study reports on research…

  5. 36 CFR 1275.46 - Segregation and review; Senior Archival Panel; Presidential Materials Review Board.

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ...; Senior Archival Panel; Presidential Materials Review Board. 1275.46 Section 1275.46 Parks, Forests, and... Access by the Public § 1275.46 Segregation and review; Senior Archival Panel; Presidential Materials... a panel of senior archivists selected by the Archivist. The Panel shall then have the sole...

  6. 75 FR 59704 - Office of Management; Performance Review Board Membership

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  7. 77 FR 66909 - Notification of Contact Information Change for the Benghazi Accountability Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  8. 5 CFR 1633.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 5 Administrative Personnel 3 2011-01-01 2011-01-01 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...

  9. 5 CFR 1633.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Code of Federal Regulations, 2010 CFR

    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...

  10. 5 CFR 1633.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 5 Administrative Personnel 3 2013-01-01 2013-01-01 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...

  11. 5 CFR 1633.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 5 Administrative Personnel 3 2012-01-01 2012-01-01 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...

  12. 5 CFR 1633.1 - Cross-reference to employee ethical conduct standards and financial disclosure regulations.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 5 Administrative Personnel 3 2014-01-01 2014-01-01 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...

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

    PubMed

    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.

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

    PubMed Central

    Kahrass, Hannes; Strech, Daniel; Mertz, Marcel

    2016-01-01

    Background 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. Aim To identify the full spectrum of clinical ethical issues that can arise for patients with kidney failure in a systematic and transparent manner. Method 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. Results 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. Conclusions 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. PMID:26938863

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

    PubMed

    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.

  16. Background Material for the Human Studies Review Board's Review of Hansson and Roos 1987

    EPA Pesticide Factsheets

    Journal article and details of EPA's science and ethics reviews of the study by Hansson and Roos from 1987: The Effect of Fluoride and Calcium on Spinal Bone Mineral Content: A Controlled, Prospective (3 Years) Study.

  17. Research Ethics Training in Peru: A Case Study

    PubMed Central

    Lescano, A. Roxana; Blazes, David L.; Montano, Silvia M.; Moran, Zoe; Naquira, Cesar; Ramirez, Edwin; Lie, Reidar; Martin, Gregory J.; Lescano, Andres G.; Zunt, Joseph R.

    2008-01-01

    With the rapidly increasing number of health care professionals seeking international research experience, comes an urgent need for enhanced capacity of host country institutional review boards (IRB) to review research proposals and ensure research activities are both ethical and relevant to the host country customs and needs. A successful combination of distance learning, interactive courses and expert course instructors has been applied in Peru since 2004 through collaborations between the U.S. Naval Medical Research Center Detachment, the University of Washington and the Department of Clinical Bioethics of the National Institutes of Health to provide training in ethical conduct of research to IRB members and researchers from Peru and other Latin American countries. All training activities were conducted under the auspices of the Peruvian National Institute of Health (INS), Ministry of Health. To date, 927 people from 12 different Latin American countries have participated in several of these training activities. In this article we describe our training model. PMID:18818763

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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.

  1. 32 CFR 581.1 - Army Disability Review Board.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... 32 National Defense 3 2014-07-01 2014-07-01 false Army Disability Review Board. 581.1 Section 581.1 National Defense Department of Defense (Continued) DEPARTMENT OF THE ARMY PERSONNEL PERSONNEL... an administrative agency created within the Department of the Army under authority of section 302...

  2. 76 FR 45594 - Mortgagee Review Board: Administrative Actions

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-07-29

    ...: Administrative Actions AGENCY: Office of the Assistant Secretary for Housing--Federal Housing Commissioner, HUD. ACTION: Notice. SUMMARY: In compliance with Section 202(c)(5) of the National Housing Act, this notice advises of the cause and describes the administrative actions taken by HUD's Mortgagee Review Board...

  3. 78 FR 44563 - Senior Executive Service (SES) Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  4. 75 FR 49938 - Proposed Collection; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-08-16

    ... Institutional Review Board (CIRB). Type of Information Collection Request: Existing Collection in Use Without an... level of reviewer and board member satisfaction and is absent of conflicts of interest with the... operations as well as a non-disclosure agreement. A conflict of interest form is completed occasionally or...

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

    PubMed

    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.

  6. 77 FR 48611 - Rules of Practice for Trials Before the Patent Trial and Appeal Board and Judicial Review of...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-14

    ... consolidated set of rules relating to Board trial practice for inter partes review, post-grant review, the... rules relating to Board trial practice for inter partes review, post- grant review, the transitional...), to provide a consolidated set of rules relating to Board trial practice for inter partes review, post...

  7. Ethical dilemmas facing chief nurses in Japan: A Pilot study.

    PubMed

    Ito, Chiharu; Natsume, Mikiko

    2016-06-01

    Chief nurses are most likely to take the lead in discussing and working to resolve ethical dilemmas, creating an ethical culture within their organization that results in effective ethics training. As the first step in this process, there is a need to define the kinds of ethical dilemmas that chief nurses grapple with on a regular basis as a target for future study. Anonymous written questionnaires and semi-structured interviews. All research procedures were approved by the Chubu University Ethics Review Board, the research institution to which the authors belong (authorization no. 250016). Responses from four chief nurses indicated that ethical dilemmas could be categorized as either those related to patient dignity or those related to management (unique to their roles as administrators). It was also learned that chief nurses struggle with the fact that although they consult with their superiors and others, these efforts do not lead to resolution. The expectation is that going forward, chief nurses will play a central role in acting as coordinators with physicians to promote better communication as well as lead group discussions aimed at providing care that respects patient dignity. © The Author(s) 2015.

  8. Research in disaster settings: a systematic qualitative review of ethical guidelines.

    PubMed

    Mezinska, Signe; Kakuk, Péter; Mijaljica, Goran; Waligóra, Marcin; O'Mathúna, Dónal P

    2016-10-21

    Conducting research during or in the aftermath of disasters poses many specific practical and ethical challenges. This is particularly the case with research involving human subjects. The extraordinary circumstances of research conducted in disaster settings require appropriate regulations to ensure the protection of human participants. The goal of this study is to systematically and qualitatively review the existing ethical guidelines for disaster research by using the constant comparative method (CCM). We performed a systematic qualitative review of disaster research ethics guidelines to collect and compare existing regulations. Guidelines were identified by a three-tiered search strategy: 1) searching databases (PubMed and Google Scholar), 2) an Internet search (Google), and 3) a search of the references in the included documents from the first two searches. We used the constant comparative method (CCM) for analysis of included guidelines. Fourteen full text guidelines were included for analysis. The included guidelines covered the period 2000-2014. Qualitative analysis of the included guidelines revealed two core themes: vulnerability and research ethics committee review. Within each of the two core themes, various categories and subcategories were identified. Some concepts and terms identified in analyzed guidelines are used in an inconsistent manner and applied in different contexts. Conceptual clarity is needed in this area as well as empirical evidence to support the statements and requirements included in analyzed guidelines.

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

    PubMed

    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.

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

    PubMed

    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.

  11. Institutional review board-based recommendations for medical institutions pursuing protocol approval for facial transplantation.

    PubMed

    Siemionow, Maria Z; Gordon, Chad R

    2010-10-01

    Preliminary outcomes from the previous nine face transplants performed since 2005 have been encouraging and have therefore led to a rise in the number of medical centers interested in establishing face transplant programs worldwide. However, until now, very little literature has been published providing surgeons the necessary insight on how to (1) prepare a protocol for institutional review board approval and (2) establish a face transplant program. The authors' face transplant team's experience with the institutional review board at the Cleveland Clinic, beginning in 2002, was critically reviewed in a detailed, retrospective manner. The purpose was to identify and define certain criteria necessary for both the institutional review board approval process and face transplant program establishment. In 2002, unprecedented efforts from within the authors' plastic surgery department led to the world's first institutional review board approval for face transplantation, in 2004. As a result, 4 years later, the authors' face transplant team performed the nation's first successful near-total face and maxilla transplant. Every surgical department hoping to establish a face transplant program must realize that this endeavor requires both tremendous financial and long-term commitments by its medical institution. These transplants should be performed only within university-based medical centers capable of orchestrating a specialized, talented, multidisciplinary team. More importantly, facial composite tissue allotransplantation possesses an unmatched level of complexity and therefore requires most centers to prepare a carefully detailed protocol using these institutional review board-based guidelines.

  12. Ethical Challenges in Promoting the Implementation of Preventive Interventions: Report of the SPR Task Force.

    PubMed

    Leadbeater, Bonnie J; Dishion, Tom; Sandler, Irwin; Bradshaw, Catherine P; Dodge, Kenneth; Gottfredson, Denise; Graham, Phillip W; Lindstrom Johnson, Sarah; Maldonado-Molina, Mildred M; Mauricio, Anne M; Smith, Emilie Phillips

    2018-06-23

    Prevention science researchers and practitioners are increasingly engaged in a wide range of activities and roles to promote evidence-based prevention practices in the community. Ethical concerns invariably arise in these activities and roles that may not be explicitly addressed by university or professional guidelines for ethical conduct. In 2015, the Society for Prevention Research (SPR) Board of Directors commissioned Irwin Sandler and Tom Dishion to organize a series of roundtables and establish a task force to identify salient ethical issues encountered by prevention scientists and community-based practitioners as they collaborate to implement evidence-based prevention practices. This article documents the process and findings of the SPR Ethics Task Force and aims to inform continued efforts to articulate ethical practice. Specifically, the SPR membership and task force identified prevention activities that commonly stemmed from implementation and scale-up efforts. This article presents examples that illustrate typical ethical dilemmas. We present principles and concepts that can be used to frame the discussion of ethical concerns that may be encountered in implementation and scale-up efforts. We summarize value statements that stemmed from our discussion. We also conclude that the field of prevention science in general would benefit from standards and guidelines to promote ethical behavior and social justice in the process of implementing evidence-based prevention practices in community settings. It is our hope that this article serves as an educational resource for students, investigators, and Human Subjects Review Board members regarding some of the complexity of issues of fairness, equality, diversity, and personal rights for implementation of preventive interventions.

  13. 75 FR 68669 - Senior Executive Service; Departmental Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  14. A review of improved ethical practices in environmental and public health research: case examples from native communities.

    PubMed

    Quigley, Dianne

    2006-04-01

    This article presents a review of 14 case studies and articles of research ethics issues in the conduct of environmental and public health research with Native American and other indigenous populations. The purpose of this review is to highlight new practices in the ethical conduct of research with native community populations. The findings from this review can promote more dialogue and policy development on the issue of community protections in research. Formal guidelines exist in ethical codes for individual rights as human subjects, but there is a lack of development on community rights in the ethics of research. This review illustrates how community-based participatory research practices can provide working guidelines that can overcome past research harms. More important, the compilations of guidelines offer tested field methods for improving the ethical conduct of research with native community populations.

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

    ERIC Educational Resources Information Center

    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…

  16. Understanding Health Research Ethics in Nepal.

    PubMed

    Sharma, Jeevan Raj; Khatri, Rekha; Harper, Ian

    2016-12-01

    Unlike other countries in South Asia, in Nepal research in the health sector has a relatively recent history. Most health research activities in the country are sponsored by international collaborative assemblages of aid agencies and universities. Data from Nepal Health Research Council shows that, officially, 1,212 health research activities have been carried out between 1991 and 2014. These range from addressing immediate health problems at the country level through operational research, to evaluations and programmatic interventions that are aimed at generating evidence, to more systematic research activities that inform global scientific and policy debates. Established in 1991, the Ethical Review Board of the Nepal Health Research Council (NHRC) is the central body that has the formal regulating authority of all the health research activities in country, granted through an act of parliament. Based on research conducted between 2010 and 2013, and a workshop on research ethics that the authors conducted in July 2012 in Nepal as a part of the on-going research, this article highlights the emerging regulatory and ethical fields in this low-income country that has witnessed these increased health research activities. Issues arising reflect this particular political economy of research (what constitutes health research, where resources come from, who defines the research agenda, culture of contract research, costs of review, developing Nepal's research capacity, through to the politics of publication of data/findings) and includes questions to emerging regulatory and ethical frameworks. © 2016 The Authors Developing World Bioethics Published by John Wiley & Sons Ltd.

  17. 78 FR 69426 - Submission for OMB Review; 30-Day Comment Request: NIH NCI Central Institutional Review Board...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-19

    ... includes oncology physicians, surgeons, nurses, patient advocates, ethicists, statisticians, pharmacists... Pharmacist's Review of a Cooperative Board Members 10 1 2 20 Group Study. Pediatric Pharmacist's Review of a...

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

    PubMed

    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.

  19. 77 FR 21109 - Senior Executive Service; Appointment of Members to the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

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

    PubMed

    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.

  2. 12 CFR 239.66 - Board review of the voluntary supervisory conversion application.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 4 2012-01-01 2012-01-01 false Board review of the voluntary supervisory conversion application. 239.66 Section 239.66 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM (CONTINUED) MUTUAL HOLDING COMPANIES (REGULATION MM) Conversions...

  3. 12 CFR 239.66 - Board review of the voluntary supervisory conversion application.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 4 2013-01-01 2013-01-01 false Board review of the voluntary supervisory conversion application. 239.66 Section 239.66 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM (CONTINUED) MUTUAL HOLDING COMPANIES (REGULATION MM) Conversions...

  4. 12 CFR 239.66 - Board review of the voluntary supervisory conversion application.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 4 2014-01-01 2014-01-01 false Board review of the voluntary supervisory conversion application. 239.66 Section 239.66 Banks and Banking FEDERAL RESERVE SYSTEM (CONTINUED) BOARD OF GOVERNORS OF THE FEDERAL RESERVE SYSTEM (CONTINUED) MUTUAL HOLDING COMPANIES (REGULATION MM) Conversions...

  5. 76 FR 64430 - Notice of Performance Review Board Members

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-18

    ... DEPARTMENT OF VETERANS AFFAIRS Corporate Senior Executive Management Office Notice of Performance Review Board Members AGENCY: Department of Veterans Affairs. ACTION: Notice. SUMMARY: Under the..., Corporate Senior Executive Management Office, Department of Veterans Affairs, 810 Vermont Avenue, NW...

  6. 45 CFR 16.14 - How Board review is limited.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 45 Public Welfare 1 2010-10-01 2010-10-01 false How Board review is limited. 16.14 Section 16.14 Public Welfare DEPARTMENT OF HEALTH AND HUMAN SERVICES GENERAL ADMINISTRATION PROCEDURES OF THE... applicable laws and regulations. ...

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

    NASA Astrophysics Data System (ADS)

    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

  8. 78 FR 58383 - Senior Executive Service; Combined Performance Review Board (PRB)

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  9. 10 CFR 709.16 - Application of Counterintelligence Evaluation Review Boards in reaching conclusions regarding CI...

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... 10 Energy 4 2010-01-01 2010-01-01 false Application of Counterintelligence Evaluation Review Boards in reaching conclusions regarding CI evaluations. 709.16 Section 709.16 Energy DEPARTMENT OF... Counterintelligence Evaluation Review Board's views, including any consensus recommendation, or if the members are...

  10. 76 FR 69770 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    PubMed

    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.

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

    PubMed

    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.

  13. 4th annual primary care ethics conference: ethics education and lifelong learning

    PubMed Central

    Spicer, John; McKenzie-Edwards, Emma; Misselbrook, David

    2014-01-01

    Primary care ethics is a field of study that has recently found new life, with calls to establish the relevance of ethical discussion in general practice, to gather a body of literature and to carve out an intellectual space for primary care on the academic landscape of bioethics. In this report, we reflect on the key strands of the 4th primary care ethics conference held at the Royal Society of Medicine, on a theme of ethics education and lifelong learning: first, to produce insights that have relevance for policy and practice; and second, to illustrate the idea that not only is ethics relevant in primary care, but primary care is relevant in medical ethics. Core themes included the advantages and disadvantages of prescriptive ways of doing ethics in education, ethical reflection and potential risk to professional status, the need to deal with societal change and to take on board the insights gained from empirical work, whether this is about different kinds of fatherhood, or work on the causes of moral distress in healthcare workers. PMID:25949739

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

    PubMed Central

    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 differing theoretical approaches such as cognitive moral development and the four principles of biomedical ethics. Research with pharmacy student cohorts is common, as is representation from American pharmacists. Many examples of ethical problems are identified, as well as commercial and legal influences on ethical understanding and decision making. In this paper, it is argued that as pharmacy seeks to develop additional roles with concomitant ethical responsibilities, a new prescription is needed for empirical ethics research in pharmacy—one that embraces an agenda of systematic research using a plurality of methodological and theoretical approaches to better explore this under‐researched discipline. PMID:17264193

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

    PubMed

    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.

  16. 76 FR 61346 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

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

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-05

    ... OFFICE OF PERSONNEL MANAGEMENT Senior Executive Service-Performance Review Board AGENCY: Office of... evaluates the initial appraisal 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...

  18. 77 FR 60450 - Senior Executive Service Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  19. 48 CFR 749.111-70 - Termination settlement review boards.

    Code of Federal Regulations, 2010 CFR

    2010-10-01

    ... 48 Federal Acquisition Regulations System 5 2010-10-01 2010-10-01 false Termination settlement review boards. 749.111-70 Section 749.111-70 Federal Acquisition Regulations System AGENCY FOR INTERNATIONAL DEVELOPMENT CONTRACT MANAGEMENT TERMINATION OF CONTRACTS General Principles 749.111-70 Termination...

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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.

  4. 76 FR 47613 - Board Meeting: September 13-14, 2011-Salt Lake City, UT; the U.S. Nuclear Waste Technical Review...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-05

    ... NUCLEAR WASTE TECHNICAL REVIEW BOARD Board Meeting: September 13-14, 2011--Salt Lake City, UT; the U.S. Nuclear Waste Technical Review Board Will Meet To Discuss DOE Plans for Used Fuel Disposition R... Amendments Act of 1987, the U.S. Nuclear Waste Technical Review Board will hold a public meeting in Salt Lake...

  5. 12 CFR 1710.14 - Code of conduct and ethics.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... 12 Banks and Banking 7 2011-01-01 2011-01-01 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...

  6. 12 CFR 1710.14 - Code of conduct and ethics.

    Code of Federal Regulations, 2010 CFR

    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...

  7. 12 CFR 1710.14 - Code of conduct and ethics.

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... 12 Banks and Banking 9 2012-01-01 2012-01-01 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...

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

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... 12 Banks and Banking 10 2014-01-01 2014-01-01 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. 12 CFR 1710.14 - Code of conduct and ethics.

    Code of Federal Regulations, 2013 CFR

    2013-01-01

    ... 12 Banks and Banking 9 2013-01-01 2013-01-01 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...

  10. 78 FR 70352 - Notice of Appointments of Individuals to Serve as Members of Performance Review Boards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-11-25

    ... NATIONAL LABOR RELATIONS BOARD Notice of Appointments of Individuals to Serve as Members of Performance Review Boards AGENCY: National Labor Relations Board. ACTION: The National Labor Relations Board is issuing this notice that the individuals whose names and position titles appear below have been...

  11. Evaluating waste printed circuit boards recycling: Opportunities and challenges, a mini review.

    PubMed

    Awasthi, Abhishek Kumar; Zlamparet, Gabriel Ionut; Zeng, Xianlai; Li, Jinhui

    2017-04-01

    Rapid generation of waste printed circuit boards has become a very serious issue worldwide. Numerous techniques have been developed in the last decade to resolve the pollution from waste printed circuit boards, and also recover valuable metals from the waste printed circuit boards stream on a large-scale. However, these techniques have their own certain specific drawbacks that need to be rectified properly. In this review article, these recycling technologies are evaluated based on a strength, weaknesses, opportunities and threats analysis. Furthermore, it is warranted that, the substantial research is required to improve the current technologies for waste printed circuit boards recycling in the outlook of large-scale applications.

  12. 75 FR 67696 - Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    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...

  13. Chinese nurses' perceived barriers and facilitators of ethical sensitivity.

    PubMed

    Huang, Fei Fei; Yang, Qing; Zhang, Jie; Khoshnood, Kaveh; Zhang, Jing Ping

    2016-08-01

    An overview of ethical sensitivity among Chinese registered nurses is needed to develop and optimize the education programs and interventions to cultivate and improve ethical sensitivity. The study was conducted to explore the barriers to and facilitators of ethical sensitivity among Chinese registered nurses working in hospital settings. A convergent parallel mixed-methods research design was adopted. In the cross-sectional quantitative study, the Chinese Moral Sensitivity Questionnaire-revised version was used to assess the levels of ethical sensitivity among registered nurses, and the scores were correlated with key demographics, training experiences in ethics, and workplace cultural environments (n = 306). In the qualitative study, semi-structured interviews were used to elicit the nurses' perceptions of the barriers and facilitators in nurturing ethical sensitivity (n = 15). The data were collected from February to June 2014. This study was approved by the Institutional Review Boards of Yale University and Central South University. Despite moderately high overall Chinese Moral Sensitivity Questionnaire-revised version scores, the ethical sensitivity among Chinese nurses lags in practice. Barriers to ethical sensitivity include the lack of knowledge related to ethics, lack of working experience as a nurse, the hierarchical organizational climate, and the conformist working attitude. The positive workplace cultural environments and application of ethical knowledge in practice were considered potential facilitators of ethical sensitivity. The findings of this study were compared with studies from other countries to examine the barriers and facilitators of ethical sensitivity in Chinese nurses. This mixed-methods study showed that even though the Chinese nurses have moderately high sensitivity to the ethical issues encountered in hospitals, there is still room for improvement. The barriers to and facilitators of ethical sensitivity identified here offer new and

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

    PubMed

    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.

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

    PubMed

    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.

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

    PubMed

    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

  17. 75 FR 60090 - Membership of the Performance Review Board

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-09-29

    ...: Missile Defense Agency (MDA), DoD. ACTION: Notice. SUMMARY: This notice announces the appointment of the members of the Performance Review Board (PRB) of the Missile Defense Agency (MDA). The publication of PRB... CONTACT: Jovey Martir, MDA SES Program Management, Missile Defense Agency, Arlington, Virginia, (703) 693...

  18. Ethical Review as a Tool for Enhancing Postgraduate Supervision and Research Outcomes in the Creative Arts

    ERIC Educational Resources Information Center

    Romano, Angela

    2016-01-01

    This article outlines the potential for Research Higher Degree (RHD) supervisors at universities and similar institutions to use ethical review as a constructive, dynamic tool in guiding RHD students in the timely completion of effective, innovative research projects. Ethical review involves a bureaucratized process for checking that researchers…

  19. 75 FR 70268 - Submission for OMB Review; Comment Request; NIH NCI Central Institutional Review Board (CIRB...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2010-11-17

    ... number. Proposed Collection: Title: NIH NCI Central Institutional Review Board (CIRB). Type of... is absent of conflicts of interest with the protocols under review. Tools utilized to accomplish this... information on workflow and processes of CIRB operations as well as a non-disclosure agreement. A conflict of...

  20. 76 FR 52735 - Members of Senior Executive Service Performance Review Boards

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-08-23

    ... DEPARTMENT OF THE TREASURY Internal Revenue Service Members of Senior Executive Service Performance Review Boards AGENCY: Internal Revenue Service (IRS), Treasury. ACTION: Notice. SUMMARY: The... 52736