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The views of members of Local Research Ethics Committees, researchers and members of the public towards the roles and functions of LRECs.

BACKGROUND: It can be argued that the ethical conduct of research involves achieving a balance between the rights and needs of three parties-potential research participants, society, and researchers. Local Research Ethics Committees (LRECs) have a number of roles and functions in the research enterprise, but there have been some indications that LREC members, researchers and the public can have different views about these responsibilities. Any such differences are potential sources of disagreement and misunderstanding. OBJECTIVES: To compare the views of LREC members, researchers and the public towards the roles and functions of LRECs. DESIGN: A questionnaire that contained items concerned with a variety of such roles was distributed to general practice patients (as proxies for potential research participants), researchers and LREC members. FINDINGS: While general practice patients believed that the main function of LRECs is to ensure that research participants come to no harm, LREC members were more concerned with the protection of participants' rights. There was also some disagreement between members and researchers with regard to the consideration of proposals on the grounds of scientific merit. CONCLUSIONS: Local Research Ethics Committee members need to be aware of potential differences in views, that they ought to make their priorities clear, and that membership of LRECs ought to reflect the views of both researchers and potential research participants.

Attitude of Health Personnel↗

The value of collaborative governance/staff empowerment.

OBJECTIVE: Collaborative governance is the decision-making process that places the authority, responsibility, and accountability for patient care with the practicing clinician. BACKGROUND: Collaborative governance was introduced as one of nine structures within the patient care services' professional practice model to facilitate communication and optimize staff participation in decision-making across disciplines. The concept of empowerment was used to evaluate the impact of the collaborative governance structure on members. METHODS: The purpose of the current study was to compare empowerment and power scores for both members and nonmembers of collaborative governance over a 3-year period. RESULTS: Initial survey data (baseline) from 136 staff from across disciplines was returned prior to beginning work on a committee. Study results were based on survey returns from 657 staff over a 3.5-year period. There were no significant differences between collaborative governance members and nonmembers on some demographic variables such as age, but there were significant differences on variables such as work status and education. All empowerment scores were significantly higher at the 2nd and 3rd measurement periods for collaborative governance members as compared to nonmembers. CONCLUSIONS: Findings suggest that membership on a collaborative governance committee increased staff sense of empowerment and fostered self-growth and organizational development.

Analysis of Variance↗

Society for Public Health Education: survey of membership.

The Society for Public Health Education, Inc. (SOPHE), through the Research and Evaluation Committee (REC) of the Tennessee chapter has surveyed its membership to determine characteristics of members, members' opinions of the organization and the benefits derived, usefulness of SOPHE publications, and the most important health education issues and goals. Survey results provide an employment profile of the membership, and indicate the membership benefits which are most valued; they also suggest that the organization's goals and its activities be expanded in scope to include, in addition to other areas, greater attention to health education practice, to planning legislation, to funding, and to cooperation with the American Public Health Association in the general promotion of health education. REC presents recommendations based on these findings.

Employment↗

[Clinical ethics committees are tested in Norway].

Health care ethics committees are now established at three hospitals in Norway as a result of a three year project in cooperation with the Centre for Medical Ethics and the Ministry of Health and Social Affairs. This article describes the project and discusses various difficulties regarding the establishment and functioning of health care ethics committees, such as their mandate and membership, the understanding of ethics and methodology, the role of ethical expertise and the relation between physicians' decision-making responsibility and a health care ethics committee.

Clinical Competence↗

Revising the British Occupational Hygiene Society asbestos standard: 1968-1982.

BACKGROUND: In 1968 the British Occupational Hygiene Society (BOHS) published a chrysotile asbestos hygiene standard. As a consequence of acknowledged inadequacies of the data, it underestimated the risks of exposure, but its influence was international and operated for longer than it merited. Five years later, BOHS reported the standard not to be in need of amending, despite its own doubts and no cognizance having been taken of the cancer hazard. Within months, stung by criticism from Dr. Irving J. Selikoff, industry required it to review the standard, which BOHS continued to do for a number of years before giving up. METHODS: Material obtained for the American Courts by means of legal discovery from an asbestos company's archive, provided information on the membership of the new BOHS committees, and on its operation. RESULTS: Alterations in the composition of the new committees included importantly the introduction of certain independent scientists, whose rigor militated against the ready production of a new hygiene standard acceptable to industry. CONCLUSIONS: There was a time in Britain when a learned society might with impunity omit to consult the views of workers or their representatives when making value judgments about their health and safety, but consider it proper to accede to industry's decision as to what hygiene standard it would accept. Health and Safety at Work legislation in 1974, established an organization on which industry and labor were represented, with the onus for recommending hygiene standards. For several years the BOHS Asbestos Sub-Committee continued attempting to reconcile the interests of industry, until finally abandoning hygiene standard setting as its mission.

Academies and Institutes↗

Shared leadership and the evolution of "one great department".

In 2001, Banner Baywood Medical Center's (BBMC) medical imaging department employed concepts to engage staff in a participative decision-making practice regarding those things that most impacted their jobs. A 5-member Oversight Committee was charged with defining a vision for the department to be achieved by 2005, determining obstacles or challenges that needed to be overcome in order to achieve the vision, and facilitating 12-week teams to find solutions to these obstacles. Several initiatives were implemented to ensure competitive salaries, more effective leadership, and overall greater participation by staff in the decision-making process. Within the project's first 18 months, the department's turnover rate was reduced from 40% to 14.5%. However, as the department continued to grow, it became evident that the structure of the Oversight Committee was no longer sufficient to achieve its goals. The members of the Oversight Committee decided to expand its membership to include a representative from every work group within the department. The new group was called the Strategic Thinking Group (STG). Shared leadership--defined by Conger and Pearce as "a dynamic", interactive process among individuals working in groups in which the objective is to lead one another to the achievement of the group goals--is a vital component of the department's operation. During the past 2 years, BBMC has been actively engaged in creating a workplace environment that promotes shared leadership. BBMC utilizes the Gallup Q12 Workplace Survey and the Press Ganey Patient Satisfaction Survey. These surveys use identical numerical ratings, with "5" (strongly agree/very good) the department's goal for employees and patients. Consequently, the department created a new slogan: "We Strive for 5." The outcomes of shared leadership have proven to have a positive impact on staff retention, the reduction of casual Iabor staff, employee satisfaction, and patient satisfaction.

Cost Control↗

Making research ethics review work in Zimbabwe--the case for investment in local capacity.

OBJECTIVE: To describe the status of ethics review as pertaining to medical research in Zimbabwe, to compare this with international guidelines, and thus to identify potential improvements in the process. DESIGN: The description includes background about the national review body, the Medical Research Council of Zimbabwe (MRCZ), and the findings of an analysis of institutional ethics review performed by the MRCZ liaison office. RESULTS: Discrepancies with international guidelines include application of the concepts of independent and competent review, monitoring of ongoing studies, and ensuring appropriate membership of institutional ethics review committees (IRECs). CONCLUSION: A focus on research ethics education for researchers and IREC members, as well as ensuring appropriate respect for IREC review, are opportunities for improvement in the process.

Ethical Review↗

Forum: trauma and infection: considerations for patient and health care professional.

Infection Control policies/procedures are written to reduce the risk for patient and HCW infection. But, if the policy or procedure is not practical, feasible or up-to-date, compliance will be low and risk may increase. Risk assessment within the community and evaluation of exposures to create changes using new technologies will help to protect the HCW. The ED should develop an open working relationship with the ICP and participate through active membership on the infection control committee. The ICP should spend time in the ED observing or, better yet, by spending some time walking in their shoes. Working together, sharing data on risk and exposures, compliance with PPE recommendations, and cleaning routines are ways to bring about a more risk-free environment for both patient and care provider.

Cross Infection↗

Hybrid fuzzy logic committee neural networks for recognition of swallow acceleration signals.

Biological signals are complex and often require intelligent systems for recognition of characteristic signals. In order to improve the reliability of the recognition or automated diagnostic systems, hybrid fuzzy logic committee neural networks were developed and the system was used for recognition of swallow acceleration signals from artifacts. Two sets of fuzzy logic-committee networks (FCN) each consisting of seven member networks were developed, trained and evaluated. The FCN-I was used to recognize dysphagic swallow from artifacts, and the second committee FCN-II was used to recognize normal swallow from artifacts. Several networks were trained and the best seven were recruited into each committee. Acceleration signals from the throat were bandpass filtered, and several parameters were extracted and fed to the fuzzy logic block of either FCN-I or FCN-II. The fuzzified membership values were fed to the committee of neural networks which provided the signal classification. A majority opinion of the member networks was used to arrive at the final decision. Evaluation results revealed that FCN correctly identified 16 out of 16 artifacts and 31 out of 33 dysphagic swallows. In two cases, the decision was ambiguous due to the lack of a majority opinion. FCN-II correctly identified 24 out of 24 normal swallows, and 28 out of 29 artifacts. In one case, the decision was ambiguous due to the lack of a majority opinion. The present hybrid intelligent system consisting of fuzzy logic and committee networks provides a reliable tool for recognition and classification of acceleration signals due to swallowing.

Acceleration↗

The multifocused faculty selection model: a design for hiring the best faculty.

The multifocused faculty selection model is designed to assist the faculty search committee in two ways. First, this model organizes the stages for obtaining information about the applicant's abilities related to faculty performance. Second, the model provides a consistent method for faculty selection as the membership of the department's search committee changes. The applicant selection techniques used in this model include descriptive interviewing, computer assisted data, and the teaching demonstration.

Faculty, Nursing↗

Articles address issues of integrated systems, authority, and payment.

Ethics committees are continually challenged by matters of identity. Does its membership reflect a fair representation of health care disciplines? Does the committee have the institution's or the patient's best interests at heart? Just when ethics committees seem to be getting a handle on these matters, the political environment is changing, with more hospitals becoming involved in managed care systems. So the question persists, but at a different level. The following articles summarize various ideas being proposed as solutions.

Ethics Committees↗

Monitoring of clinical trials: issues and recommendations.

Interim analyses of randomized trials enable investigators to make more efficient use of limited research resources and to satisfy ethical requirements that a regimen be discontinued as soon as it has been established to have an inferior efficacy/toxicity profile. Unfortunately, the integrity and credibility of these trials can be compromised if inappropriate procedures are used in monitoring interim data. In this paper we discuss how group sequential designs provide useful guidelines that enable one to satisfy the valid objectives of interim monitoring while avoiding undesirable consequences, and we consider how flexible one can be in the way such designs are implemented. We also provide motivation for the role of data-monitoring committees in preserving study integrity and credibility in either government- or industry-sponsored trials. In our view, these committees should have multidisciplinary representation and membership limited to individuals free of apparent significant conflict of interest, and ideally should be the only individuals to whom the data analysis center provides interim results on relative efficacy of treatment regimens. Finally, we discuss some important practical issues such as estimation following group sequential testing, analysis of secondary outcomes after using a group sequential design applied to a primary outcome, early stopping of negative trials, and the role of administrative analyses.

Clinical Trials as Topic↗

The prevalence, composition, and function of ethics committees in nursing facilities: results of a random, national survey of American Health Care Association members.

OBJECTIVES: To determine the prevalence, composition, and function of ethics committees in extended care facilities in the United States. DESIGN: Descriptive survey by mail. SETTING: A 5% random sample (n = 851) of nursing facility members of the American Health Care Association (n = 17,020). Most of these facilities (75%) are intermediate care facilities; the remainder include a varying number of skilled beds. METHODS: An eight-item questionnaire was sent to the randomly selected 851 extended care facilities. The questionnaire inquired about the existence of an ethics committee, plans for formation when applicable, composition of the ethics committee, and its function. Survey data was coded and merged with information on facility characteristics that are part of the American Health Care Association's database. RESULTS: Of the responding facilities (n = 394), 34% reported the presence of a functioning ethics committee, with an additional 19% indicating definite plans for ethic committee formation. Forty-three percent expressed no interest in establishing an ethics committee, and 4% reported having had an ethics committee sometime in the past. The greatest proportion of committee time was spent in case review (39%) with lesser amounts of time expended in areas of policy formation (27%) and education (27%). Forty percent of the ethics committees performed two or fewer case reviews per year. Nearly all committees included the following disciplines in the membership: nurses (96%), physicians (95%), and social workers (89%). Facility administrators (77%) and clergy (70%) were frequently represented. Very few facilities reported representation by residents (8%) and Certified Nursing Assistants (2%). The Medical Director served as a committee member on 75% of the ethics committees, and in more than one-half of those instances, he/she was the sole physician on the committee. CONCLUSION: Ethics committees are currently active in or there are plans for their development in more than 50% of extended care facilities in the U.S. this represents a very significant increase in prevalence during the last decade. This tendency to form ethics committee's may slow considerably in the future. Ethics committees exhibit considerable variability in structure and function.

Journal Article↗

Work activity of persons working as members of advisory committees established under the Federal Advisory Committee Act (FACA). Final rule.

We are revising our disability regulations under titles II and XVI of the Social Security Act to establish a new, special rule that affects individuals who are receiving payments or providing services as members or consultants of a committee, board, commission, council or similar group established under the Federal Advisory Committee Act (FACA). Under this special rule, we will not count any earnings an individual is receiving from serving as a member or consultant of a FACA advisory committee when we determine if the individual is engaging in substantial gainful activity under titles II and XVI of the Social Security Act (the Act). In addition, we will not evaluate any of the services the individual is providing as a member or consultant of the FACA advisory committee when determining if the individual has engaged in substantial gainful activity under titles II and XVI of the Act. Based on our experience with FACA advisory committees and the frequency and level of activity required by these committees, we believe that performance of activity on these committees does not demonstrate the ability to perform substantial gainful activity. We believe this to be consistent with Congress's view, as it has recognized in creating the Ticket to Work advisory committee, for example, that current disability beneficiaries should be considered for membership. This also will encourage individuals with disabilities to serve on FACA advisory committees, thereby providing the benefit of their unique perspective on policies and programs to the Federal Government.

Advisory Committees↗