AJOB primary research最新文献

{"title":"Views of IRBs Concerning their Local Ecologies: Perceptions of Relationships, Systems, and Tensions between IRBs and their Institutions.","authors":"Robert Klitzman","doi":"10.1080/21507716.2012.757255","DOIUrl":"10.1080/21507716.2012.757255","url":null,"abstract":"<p><strong>Background: </strong>Research has generally examined institutional review boards (IRBs) in isolation, but critical questions arise of how these entities fit into the larger institutional contexts in which they operate and what the implications may be.</p><p><strong>Methods: </strong>Semi-structured interviews were conducted with leaders of IRBs from among the top 240 institutions receiving funding from the National Institutes of Health.</p><p><strong>Results: </strong>Interviewees felt that institutions may affect IRBs through both broad, indirect features (e.g., size, type of research, and culture of the institution), and more direct, IRB-related factors (e.g., amount of leadership and resource support for the IRB). Interviewees thought that institutional support of IRBs ranged from financial to non-financial, direct and indirect, and that these institutional factors can mold amounts of IRB staff and education, audits, and education of principal investigators (PIs), and tensions IRBs had to address. Respondents felt that these factors can in turn potentially affect IRB reviews of protocols and interactions with principle investigators (PIs). Within the complex systems of an institution, IRBs felt that PIs' experiences and complaints about the IRB to institutional leaders may also shape how the institution related to the IRB.</p><p><strong>Conclusions: </strong>These data are the first to show how IRBs perceive themselves as working within the contexts of dynamic local institutional relationships and systems that pose challenges and tensions that can potentially affect critical aspects of IRB functioning. The findings have implications for practice, future research, and policy.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"4 2","pages":"31-43"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3670805/pdf/nihms460483.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31488660","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Factors that Affect Integrity of Authorship of Scientific Meeting Abstracts.","authors":"John Lynch,&nbsp;Jane E Strasser,&nbsp;Christopher J Lindsell,&nbsp;Joel Tsevat","doi":"10.1080/21507716.2012.757259","DOIUrl":"https://doi.org/10.1080/21507716.2012.757259","url":null,"abstract":"Background: Strict criteria for article authorship exist to guide decisions on who should be considered an author. Less is known about how authorship for scientific meetings is determined. Our goal was to explore factors that influence decisions about authorship of conference abstracts. Methods: In 2010, we conducted qualitative focus groups with a stratified sample of 36 trainees, 19 junior faculty members, and 11 senior faculty members. Focus-group transcripts were coded using a coding scheme derived from an initial review of the transcripts and a preliminary theoretical framework, which was based on the literature, anecdotes, and personal experience. Results: We identified six themes related to abstract authorship: comparisons with articles; collaboration dynamics; time; experience and professional development; standards for authorship; and funding. We found that views of abstracts as a lesser form of publication lead to diminished integrity of authorship; trainee inexperience and the dynamics of collaboration adversely influence the integrity of authorship independently of the perceived difference between an abstract and an article; and early communication about authorship appears to increase the integrity of authorship decisions. Conclusions: Authors do not hold abstracts to the same standard as articles. As such, abstract authorship decisions are frequently inconsistent with authorship criteria pertaining to manuscripts. Such inconsistencies might be improved with stricter institutional rules, clear and consistent authorship guidelines for abstracts submitted to conferences, a requirement that all authors verify their contributions to the abstract, and additional training in the responsible conduct of research.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"4 2","pages":"15-22"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21507716.2012.757259","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31608314","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The IntegratedEthicsTM Staff Survey: A Tool to Evaluate and Improve Ethical Practices in Health Care","authors":"R. Pearlman, M. Bottrell, Jane K Altemose, M. Foglia, E. Fox","doi":"10.1080/21507716.2012.752416","DOIUrl":"https://doi.org/10.1080/21507716.2012.752416","url":null,"abstract":"Background: To improve ethics quality in health care, health care organizations need a way to characterize whether ethical practices throughout the organization are consistent with accepted ethics standards, norms, and expectations for the organization and its staff. We developed the IntegratedEthics™ Staff Survey (IESS) to fill this need. Methods: The IESS was developed and validated through a rigorous multiyear process. This process included reviews of the bioethics and health care literature to develop conceptual maps of common ethical issues in health care; focus groups and interviews with institutional stakeholders to identify key ethical concerns; cognitive testing, pilot testing, and field testing to ensure that questions were understandable and useful; and item reduction and modification to reduce respondent burden. Results: The IESS addresses staff perceptions of ethical practices in nine domains: everyday workplace, business and management, government service, patient privacy and confidentiality, resource allocation, shared decision making with patients, professionalism in patient care, end-of-life care, and research. The 2010 version of the survey consisted of 76 questions (excluding 8 demographic questions), including questions about the degree to which facility staff demonstrate behavior consistent with specific ethical practices, systems-level or organizational factors that support or interfere with ethical practices, and the ethical environment and culture. The IESS has served as a catalyst for multiple quality improvement and educational activities. Conclusions: The IESS represents an across-the-board approach to measuring ethics quality in multiple areas encompassing clinical, organizational, and research ethics. In addition to its use in quality improvement efforts, the IESS may be used to assess whether there are systematic differences across different disciplines, services, and supervisory levels; to evaluate the effectiveness of ethics programs; and to identify trends in ethical practices over time.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"41 1","pages":"19 - 7"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81639640","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perceptions of Ethical Leadership and the Ethical Environment and Culture: IntegratedEthicsTM Staff Survey Data from the VA Health Care System","authors":"M. Foglia, Jennifer Cohen, R. Pearlman, M. Bottrell, E. Fox","doi":"10.1080/21507716.2012.751070","DOIUrl":"https://doi.org/10.1080/21507716.2012.751070","url":null,"abstract":"Background: To enhance understanding of ethical leadership and the ethical environment and culture (EL/EEC) in the Department of Veterans Affairs (VA) health care system, we mapped selected questions from the VA IntegratedEthics™ Staff Survey (IESS), a national survey of employees’ perceptions of ethical practices, to the Ethical Leadership Compass Points (ELC), a tool to help leaders cultivate an environment and culture that makes it easy for employees to “do the right thing.” The ELC distills insights and principles from organizational and business ethics and provides leaders with specific behaviors that can be incorporated into daily administrative routines. Methods: We analyzed the responses of 88,605 VA employees to the 2010 IESS questions that previously were mapped to the ELC. Descriptive statistics were used to characterize overall distribution of responses to the survey questions, and Pearson's chi-squared tests were performed to assess differences in responses by employee characteristics. Multiple regression analyses examined the association between perceptions of EL/EEC and perceptions of the organizations’ overall ethics quality. Results: Physicians and employees with a higher level of supervisory responsibility were more likely to have the most positive perceptions of EL/EEC and the organization's overall ethics quality. More than three-quarters of the variation in perceptions of overall ethics quality was explained by employee perceptions of EL/EEC. The IESS questions that showed the largest associations with perceptions of overall ethics quality addressed fair allocation of resources across programs and services, avoidance of mixed messages that create ethical uncertainty or conflict, fair treatment of employees, and following up on ethical concerns reported by employees. Conclusions: These results support the important relationships between ethical leadership, an organization's environment and culture, and overall ethics quality. Certain ethical leadership practices may have a larger impact on employees’ perceptions of overall ethics quality than others.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"8 1","pages":"44 - 58"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83549475","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Empirically-derived Knowledge on Adolescent Assent to Pediatric Biomedical Research.","authors":"David G Scherer, Janet L Brody, Robert D Annett, Charles Turner, Jeanne Dalen, Yesel Yoon","doi":"10.1080/21507716.2013.806967","DOIUrl":"10.1080/21507716.2013.806967","url":null,"abstract":"<p><strong>Background: </strong>There has been a recent growth in empirical research on assent with pediatric populations, due in part, to the demand for increased participation of this population in biomedical research. Despite methodological limitations, studies of adolescent capacities to assent have advanced and identified a number of salient psychological and social variables that are key to understanding assent.</p><p><strong>Methods: </strong>The authors review a subsection of the empirical literature on adolescent assent focusing primarily on asthma and cancer therapeutic research; adolescent competencies to assent to these studies; perceptions of protocol risk and benefit; the affects of various social context variables on adolescent research participation decision making; and the inter-relatedness of these psychological and social factors.</p><p><strong>Results: </strong>Contemporary studies of assent, using multivariate methods and updated approaches to statistical modeling, have revealed the importance of studying the intercorrelation between adolescents' psychological capacities and their ability to employ these capacities in family and medical decision-making contexts. Understanding these dynamic relationships will enable researchers and ethicists to develop assent procedures that respect the authority of parents, while at the same time accord adolescents appropriate decision-making autonomy.</p><p><strong>Conclusions: </strong>Reviews of empirical literature on the assent process reveal that adolescents possess varying capacities for biomedical research participation decision making depending on their maturity and the social context in which the decision is made. The relationship between adolescents and physician-investigators can be used to attenuate concerns about research protocols and clarify risk and benefit information so adolescents, in concert with their families, can make the most informed and ethical decisions. Future assent researchers will be better able to navigate the complicated interplay of contextual and developmental factors and develop the empirical bases for research enrollment protocols that will support increased involvement of adolescents in biomedical research.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"4 3","pages":"15-26"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3728675/pdf/nihms484908.pdf","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31275603","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Ethics Quality","authors":"B. Crigger, M. Wynia","doi":"10.1080/21507716.2012.756837","DOIUrl":"https://doi.org/10.1080/21507716.2012.756837","url":null,"abstract":"This special issue of AJOB Primary Research includes a set of articles describing key aspects of the IntegratedEthicsTM (IE) program of the U.S. Department of Veterans Affairs (VA) health care system. The IE program (described more fully elsewhere; see, e.g., Fox et al. 2010) is intended to provide a comprehensive approach to promoting ethics quality in health care. Its goal is to transcend the traditional ethics committee approach by promoting ethical practices in health care using an assortment of tools to help systematize ethics consultation, support a perspective of continuous quality improvement in ethics, and foster an organizational environment and culture that makes it easy for health care personnel to “do the right thing.” IE program tools include educational resources, standardized approaches to various aspects of ethics work, outreach materials, administrative tools to help organize and document work, and assessment tools.1 This set of articles discusses two key components of the IE portfolio, the IE Staff Survey and the IE Facility Workbook, describing the development and field testing of these assessment tools and providing examples of how they have been used by VA to support and improve ethical practices in its health care facilities across the country. While the VA health care system is unique in a number of ways that have made it possible for the agency’s National Center for Ethics in Health Care (NCEHC) to develop and roll out the IE program, the remarkable and helpful body of work described in this special issue will be, we believe, influential well beyond the VA system. IntegratedEthics is groundbreaking in its breadth; its organized, systematic approach to ethical practices; its focus on the pragmatic; and its broad goals for improving ethics in health care, all of which are reflected in the tools discussed in these articles. The program’s aims are audacious, but clear. They include ensuring that ethics consultations use a","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"182 1","pages":"2 - 6"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21507716.2012.756837","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72490109","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Evaluating Ethics Quality in Health Care Organizations: Looking Back and Looking Forward","authors":"E. Fox","doi":"10.1080/21507716.2012.756836","DOIUrl":"https://doi.org/10.1080/21507716.2012.756836","url":null,"abstract":"To spark a conversation about how best to evaluate ethics quality, this article draws on the collective experience of the IntegratedEthicsTM evaluation team to reflect on what we have learned and to envision an agenda for future work. The article emphasizes the importance of beginning with a well-defined conceptual model, building an expert team, committing the resources necessary to do evaluation well, and tailoring the evaluation methods to the target audience. The article then describes a five-point agenda for future work on ethics quality in health care: further evaluate and improve ethics programs; further evaluate and improve specific ethical practices; examine the relationships among various aspects of ethics quality; examine the relationships between ethics quality and other important organizational outcomes; and foster cross-institutional collaborations to evaluate and improve ethics quality. The hope is that some day ethics will be fully integrated into the mainstream of health care quality management.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"74 1","pages":"71 - 77"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"72677877","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Perceptions of Research Ethics Practices: IntegratedEthics™ Staff Survey Data from the VA Health Care System","authors":"R. Pearlman, Jennifer Cohen, M. Foglia, E. Fox","doi":"10.1080/21507716.2012.752417","DOIUrl":"https://doi.org/10.1080/21507716.2012.752417","url":null,"abstract":"Background: There are limited empirical data on factors that influence ethical practices in research settings. To broaden our understanding of ethical practices in research in the U.S. Department of Veterans Affairs (VA) and to understand researcher- and organizational-level factors associated with positive perceptions of practices, we assessed researchers’ perceptions of practices in research ethics. Methods: We analyzed data from 10,661 respondents to the 2010 IntegratedEthics™ Staff Survey (IESS) at VA who self-identified as research staff and who worked at facilities with Federalwide Assurance for the Protection of Human Subjects. We used descriptive statistics to evaluate these respondents’ perceptions of ethical practices in research and multivariate logistic regression analyses to evaluate associations between researcher- and organization-level characteristics and positive perceptions of ethical practices. Results: The results suggest that the majority of researcher respondents have positive perceptions of ethical practices in research at VA; for example, 85% almost never feel pressured to compromise ethical standards. Physicians and staff with managerial responsibilities tend to have more favorable impressions of ethical practices in research. The results also indicate areas for improvement. For example, 14–16% of respondents report that there are research staff members who regularly engage in behaviors that may inappropriately affect their research. Furthermore, results suggest that approximately 14% of VA research staff are not completely comfortable raising ethical concerns or reporting ethical violations related to research. Conclusions: Results from this study identify areas for quality improvement that can serve as a complement to the required education and training in research ethics, policy guidance, and rigorous institutional review board oversight and monitoring.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"16 1","pages":"34 - 43"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86374498","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Editors’ Note: Acknowledgment","authors":"","doi":"10.1080/21507716.2013.757083","DOIUrl":"https://doi.org/10.1080/21507716.2013.757083","url":null,"abstract":"The editors would like to express appreciation to Dr. Ellen Fox for coordinating the development and submission of the manuscripts for this special issue of AJOB Primary Research. As the Chief Ethics in Health Care Officer at the National Center for Ethics in Health Care (NCEHC), Dr. Fox has overseen the development and implementation of innovative programs to improve ethics quality in the Veterans Health Administration (VHA). We are pleased to publish a collection of research and analyses related to evaluating and improving ethics quality, which we believe will provide our audiences with a critical, in-depth understanding of the role of empirical data in assessing the impact of bioethics on health care delivery, management, and research.","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"10 1","pages":"1 - 1"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"87411834","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Behavioral Science Research Informs Bioethical Issues in the Conduct of Large-Scale Studies of Children's Disease Risk.","authors":"Kenneth P Tercyak,&nbsp;Ulrica Swartling,&nbsp;Darren Mays,&nbsp;Suzanne Bennett Johnson,&nbsp;Johnny Ludvigsson","doi":"10.1080/21507716.2013.806968","DOIUrl":"https://doi.org/10.1080/21507716.2013.806968","url":null,"abstract":"<p><strong>Background: </strong>Birth cohort studies of the natural history of pediatric common disease risk raise many bioethical issues, including re-consenting participants over time as children mature and cohort retention. Understanding participants' study-specific knowledge, attitudes, beliefs, and behavior may offer insights into these issues from a psychological perspective.</p><p><strong>Methods: </strong>We conducted an analysis of factors associated with parent-child communication about minor children's participation in a population-based birth cohort; children's knowledge about their own participation; and parental willingness to be re-contacted for future study among Swedish parents (<i>N</i> = 3,605) of children originally enrolled at birth in a prospective study of type 1 diabetes risk.</p><p><strong>Results: </strong>More open parent-child communication about disease risk screening research and greater knowledge among children about their own research participation facilitated greater parent willingness to participate in further study. Parents' decisions about further study participation were most strongly favorable among those who communicated openly with their child and with high study-specific knowledge.</p><p><strong>Conclusions: </strong>Epidemiologists, bioethicists, and others involved in the design and conduct of large-scale, prospective birth cohorts may consider embedding periodic assessments of participants' study-specific attitudes and behavior to address long-term retention and willingness to engage in future research.</p>","PeriodicalId":89316,"journal":{"name":"AJOB primary research","volume":"4 3","pages":"4-14"},"PeriodicalIF":0.0,"publicationDate":"2013-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://sci-hub-pdf.com/10.1080/21507716.2013.806968","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"31683646","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}