Federal Guidelines (federal + guideline)

Distribution by Scientific Domains


Selected Abstracts


A Review of the Federal Guidelines That Inform and Influence Relationships Between Physicians and Industry

ACADEMIC EMERGENCY MEDICINE, Issue 8 2009
Robert H. Birkhahn MD
Abstract The effective delivery and continued advancement of health care is critically dependent on the relationship between physicians and industry. The private sector accounts for 60% of the funding for clinical research and more than 50% of the funding sources for physician education. The nature of the physician,industry relationship and the role of the physician as a gatekeeper for health care make this association vulnerable to abuse if certain safeguards are not observed. This article will review the current federal guidelines that affect the physician,industry relationship and highlight several illustrative cases to show how the potential for abuse can subvert this relationship. The recommendations and "safe harbors" that have been designed to guide business relationships in health care are discussed. [source]


Historical Analysis of Siderail Use in American Hospitals

JOURNAL OF NURSING SCHOLARSHIP, Issue 4 2001
Barbara L. Brush
Purpose: To explore the social, economic, and legal influences on siderail use in 20th century American hospitals and how use of siderails became embedded in nursing practice. Design: Social historical research. Methods: Numerous primary and secondary sources were collected and interpreted to illustrate the pattern of siderail use, the value attached to siderails, and attitudes about using siderails. Findings: The persistent use of siderails in American hospitals indicates a gradual consensus between law and medicine rather than an empirically driven nursing intervention. Use of siderails became embedded in nursing practice as nurses assumed increasing responsibility for their actions as institutional employees. Conclusions: New federal guidelines, based on reports of adverse consequences associated with siderails, are limiting siderail use in hospitals and nursing homes across the United States. Lowering siderails and using alternatives will depend on new norms among health care providers, hospital administrators, bed manufacturers, insurers, attorneys, regulators, and patients and their families. [source]


Population Genomics and Research Ethics with Socially Identifable Groups

THE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 3 2007
Joan L. McGregor
In this paper, the author questions whether the research ethics guidelines and procedures are robust enough to protect groups when conducting genetics research with socially identifiable populations, particularly with Native American groups. The author argues for a change in the federal guidelines in substance and procedures of conducting genetic research with socially identifiable groups. [source]


A Review of the Federal Guidelines That Inform and Influence Relationships Between Physicians and Industry

ACADEMIC EMERGENCY MEDICINE, Issue 8 2009
Robert H. Birkhahn MD
Abstract The effective delivery and continued advancement of health care is critically dependent on the relationship between physicians and industry. The private sector accounts for 60% of the funding for clinical research and more than 50% of the funding sources for physician education. The nature of the physician,industry relationship and the role of the physician as a gatekeeper for health care make this association vulnerable to abuse if certain safeguards are not observed. This article will review the current federal guidelines that affect the physician,industry relationship and highlight several illustrative cases to show how the potential for abuse can subvert this relationship. The recommendations and "safe harbors" that have been designed to guide business relationships in health care are discussed. [source]


Informed Consent for Research: Current Practices in Academic Emergency Medicine

ACADEMIC EMERGENCY MEDICINE, Issue 6 2008
Edward Monico MD
Abstract Background:, The emergency department (ED) environment presents unique barriers to the process of obtaining informed consent for research. Objectives:, The objective was to identify commonalities and differences in informed consent practices for research employed in academic EDs. Methods:, Between July 1, 2006, and June 30, 2007, an online survey was sent to the research directors of 142 academic emergency medicine (EM) residency training programs identified through the Accreditation Council for Graduate Medical Education (ACGME). Results:, Seventy-one (50%) responded. The average number of simultaneous clinical ED-based research projects reported was 7.3 (95% confidence interval [CI] = 5.53 to 9.07). Almost half (49.3%) of respondents reported that EM residents are responsible for obtaining consent. Twenty-nine (41.4%) participating institutions do not require documentation of an individual resident's knowledge of the specific research protocol and consent procedure before he or she is allowed to obtain consent from research subjects. Conclusions:, It is common practice in academic EDs for clinical investigators to rely on on-duty health care personnel to obtain research informed consent from potential research subjects. This practice raises questions regarding the sufficiency of the information received by research subjects, and further study is needed to determine the compliance of this consent process with federal guidelines. [source]


Executive Summary: The Institute of Medicine Report and the Future of Academic Emergency Medicine: The Society for Academic Emergency Medicine and Association of Academic Chairs in Emergency Medicine Panel: Association of American Medical Colleges Annual Meeting, October 28, 2006

ACADEMIC EMERGENCY MEDICINE, Issue 3 2007
Daniel A. Handel MD
The findings in the Institute of Medicine's Future of Emergency Care reports, released in June 2006, emphasize that emergency physicians work in a fragmented system of emergency care with limited interhospital and out-of-hospital care coordination, too few on-call specialists, minimal disaster readiness, strained inpatient resources, and inadequate pediatric emergency services. Areas warranting special attention at academic medical centers (AMCs), both those included within the report and others warranting further attention, were reviewed by a distinguished panel and include the following: 1) opportunities to strengthen and leverage the educational environment within the AMC emergency department; 2) research opportunities created by emergency medicine (EM) serving as an interdisciplinary bridge in the area of clinical and translational research; 3) enhancement of federal guidelines for observational and interventional emergency care research; 4) recognition of the importance of EM residency training, the role of academic departments of EM, and EM subspecialty development in critical care medicine and out-of-hospital and disaster medicine; 5) further assessment of the impact of a regional emergency care model on patient outcomes and exploration of the role of AMCs in the development of such a model (e.g., geriatric and pediatric centers of EM excellence); 6) t e opportunity to use educational loan forgiveness to encourage rural EM practice and the development of innovative EM educational programs linked to rural hospitals; and 7) the need to address AMC emergency department crowding and its adverse effect on quality of care and patient safety. Strategic plans should be developed on a local level in conjunction with support from national EM organizations, allied health care, specialty organizations, and consumer groups to help implement the recommendations of the Institute of Medicine report. The report recommendations and other related recommendations brought forward during the panel discussions should be addressed through innovative programs and policy development at the regional and federal levels. [source]