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Institutional Review Board (institutional + review_board)
Terms modified by Institutional Review Board Selected AbstractsA novel approach to controlling bacterial contamination on toothbrushes: chlorhexidine coatingINTERNATIONAL JOURNAL OF DENTAL HYGIENE, Issue 4 2009LA Turner Abstract:, Purpose:, This project was conducted to determine the effectiveness of chlorhexidine-coated toothbrush filaments in reducing quantities of bacteria. Materials and methods:, An Institutional Review Board (IRB)-approved, two-group, double-blind, randomized, post-test only study was conducted. Sixty-four individuals utilized control and experimental toothbrushes, for 30 days. At the end of the study toothbrushes were returned and transported to the laboratory for analysis. Microorganisms were detached from the filaments by sonification and vortexing then plated on Mitis Salivarius (MS) (selective) and trypticase soy agar (TSA) 5% Sheep Blood (non-selective) media. Inoculated plates were incubated aerobically for 24 h at 37°C. After incubation, bacterial colony-forming units (CFU) were determined. Data were analysed using Wilcoxon and Kruskal,Wallis tests. Results:, Fifty-nine toothbrushes were returned for analysis; experimental (n = 31) and control (n = 28). Data from TSA media revealed a mean CFU for the control group of 5.41 × 105 compared with 6.28 × 105 for the experimental group. Data from MS agar resulted in a mean CFU for the control group of 4.32 × 105 compared with 4.20 × 105 for the experimental group. Conclusion:, Results revealed no statistically significant difference in the quantity of bacteria surviving on toothbrush filaments between control and experimental groups, on both selective and non-selective media, after 30 days. [source] Cell Types Obtained from the Epidural Space of Patients with Low Back Pain/RadiculopathyPAIN PRACTICE, Issue 3 2009James E. Heavner PhD Abstract Background: We investigated if correlations exist between medical history, tissue abnormalities, and cell types retrieved from the epidural space of patients with chronic low back pain (LBP) and chronic radicular pain (RP). Methods: Approval was obtained from the Institutional Review Board for the Protection of Human Subjects to study 191 patients undergoing epiduroscopy. Visual inspection was performed and abnormal areas were identified. A specimen obtained from the area using a cytology brush was processed by the Thin Prep technique. Patients were divided into four groups based on the presence or absence and intensity of LBP and RP. The gender and age of the patients were recorded, as was any history of prior back surgery. Areas of tissue abnormalities were rated according to changes in vascularity and amount of fat, fibrosis, and inflammation. Stenosis was assessed from magnetic resonance imaging or computerized tomography scan images. Cytologic assessments included notations of the presence or absence of erythrocytes, leukocytes, cell groups, lipocytes, spindled cells, and large round cells. Results: There was a significant difference in the number of patients from whom big round cells were obtained who had a high degree of LBP compared with the number of patients who had a high degree of both LBP and RP. Conclusions: The findings provide a foundation for future studies of cells obtained from similar patients with the goal of furthering the understanding of the pathogenesis of LBP/RP. [source] Introduction of Infection Control Measures to Reduce Infection Associated With Implantable Pain Therapy DevicesPAIN PRACTICE, Issue 3 2007Abram H. Burgher MD Abstract Introduction: Implantable pain therapy devices for chronic pain include spinal cord stimulators (SCS) and intrathecal drug delivery systems (IDDS). A number of different complications can occur after implantation of these devices, but among the most serious is infection. Based on Centers for Disease Control and Prevention guidelines for prevention of surgical site infection, published literature on infection risk with implantable pain therapy devices, and recommendations from groups within our own our institution, we introduced infection control measures for all patients receiving either SCS or IDDS. Methods: After approval from the Institutional Review Board, we performed a retrospective review of patients undergoing primary implantation of SCS or IDDS before and after introduction at our institution of safety measures designed to reduce device-related infection. We compared infection incidence and compliance to infection precautions before and after introduction of these measures. Results: Thirty-four SCS or IDDS were implanted before implementation of the infection control measures and 58 were placed after. Five device-related infections occurred. Adherence to most infection precautions improved during the study period, but 100% compliance was seen only with venue used for implantation. Infection incidence declined after introduction of the safety measures, but the reduction was not statistically significant. Conclusions: Introduction of infection control measures for implantable pain therapy devices improved adherence to most infection precautions in our practice. Lack of specific documentation could have hindered practice surveillance within our group. A tool to document performance of infection control measures would be useful not only as a marker of compliance but could also serve as a reminder to perform certain safety measures. [source] ProSealTM laryngeal mask airway in 120 pediatric surgical patients: a prospective evaluation of characteristics and performancePEDIATRIC ANESTHESIA, Issue 3 2006MELISSA WHEELER MD Summary Background:, The ProSealTM LMA (PLMATM) has recently been introduced in pediatric sizes (1.5, 2, 2.5, 3). Limited pediatric data have been published. Methods:, After Institutional Review Board (IRB) approval, the PLMATM was placed in 120 children aged 4 months to 13 years (5,50 kg). The following data were collected prospectively: induction agent, number of placement attempts (limited to three), placement success or failure, PLMATM size, leak pressure, ventilatory pattern [spontaneous (SV) or controlled positive pressure ventilation (PPV)], success or failure of gastric suction tube placement, hypoxemia, dislodgement, laryngospasm, bronchospasm, aspiration, and traumatic placement. Results:, The PLMATM was easily placed in children with a higher first attempt success rate (94%) than reported for adults. Overall PLMATM and gastric tube placement were both 100% successful. Leak pressures were similar to those reported for the PLMATM in adults and higher than reported for the ClassicTM LMATM in children. No bronchospasm, laryngospasm, hypoxemia, dislodgement, or aspiration occurred. Conclusions:, Although the PLMATM can be used with SV or PPV, the higher leak pressure achieved with the PLMATM, and the ability to evacuate fluid and air from the stomach suggest that it may be a useful alternative to tracheal intubation for procedures in which PPV is desired in children aged 4 months to 13 years. [source] Protecting human subjects: How much responsibility falls to editorial boards?,AMERICAN JOURNAL OF INDUSTRIAL MEDICINE, Issue 2 2009David H. Wegman MD Abstract Editorial policy for biomedical journals increasingly calls on authors to affirm that approval was received from an Institutional Review Board (IRB) (or equivalent) prior to initiating any human subjects research presented in a manuscript submitted for publication. For most investigations and investigators this does not present any problem. However, when research is carried out in a setting where there is no IRB, should editors consider a report of such a study based on the merits alone? There is no simple answer to this question. This commentary explores aspects of the question and presents issues to be considered in developing an answer. Am. J. Ind. Med. 52:172,175, 2009. © 2008 Wiley-Liss, Inc. [source] Modifications of Graduate Public/ Community Health Nursing Internships to Facilitate Compliance with Institutional Review Board and Health Insurance Portability and Accountability Act (HIPAA) RegulationsPUBLIC HEALTH NURSING, Issue 2 2005Gwendolyn F. Foss ABSTRACT, This paper describes the changes that were made to a two-semester graduate internship course to facilitate student compliance with Institutional Review Board (IRB) and agency requirements for compliance with the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA). Students now spend the first semester of the internship developing collaborative relationships with the agency and conceptualizing, planning, and developing all aspects of the project, including preparing materials for an IRB review. A series of workshops about the IRB process, the Privacy Rule of HIPAA, and on-line resources have been developed. A password-protected web site and other resources were developed for preceptors. The result of the changes has been primarily positive. By having to conceptualize and develop the entire project at the beginning, students demonstrate a better understanding of program development and evaluation. Their writing has markedly improved. Preceptors like the course revisions, the convenience of on-line resources, and the enhanced course focus on the protection of health care information and of potential participants in health education programs or program evaluation projects. [source] Neurologic Diagnosis and Treatment in Patients with Computed Tomography and Nasal Endoscopy Negative Facial PainTHE LARYNGOSCOPE, Issue 11 2004Eric P. Paulson MD Abstract Objective: To determine the helpfulness of specialist neurology referral for patients with facial pain, a normal sinus computed tomography (CT) scan, and normal nasal endoscopy findings. Study Design: Prospective identification of patients and analysis of data approved by the Institutional Review Board. Methods: The data of 104 consecutive patients presenting with facial pain, a normal sinus CT scan, and normal nasal endoscopy findings were reviewed. The patients presented to a single rhinologist in a tertiary care institution. All patients were referred for specialist neurologic evaluation and potential treatment. Further information was obtained from a patient survey. Results: Of the 104 patients, 81 were women and 23 were men. The average age was 46 years (range, 22,85). Fifty-six had clear CT scans, 48 had minimal change, and all had negative endoscopies. Twenty-nine had previous unsuccessful sinus surgery. The average follow-up period was 10.5 months. Forty of 75 patients seeing a neurologist were seen on multiple occasions. Four percent of patients seen by a neurologist had an unsuspected serious intracranial diagnosis. The most common diagnoses were migraine (37%), rebound headache (17%), chronic daily headache (17%), and obstructive sleep apnea (16%). Overall, 58% improved on medical therapy; 60% of those with a clear CT scan improved, and 53% of those with minimal change on CT scan improved (P = .749). Conclusions: Facial pain remains a difficult symptom to diagnose and treat in rhinologic practice. Patients often undergo surgery without help. Most patients with facial pain, a normal sinus CT scan, and normal endoscopy findings benefit from neurologic consultation. Serious intracranial pathologic conditions can be excluded and diagnosis-specific pharmacogenetic therapy instituted with improvement in more than 50%. [source] Local institutional review board (IRB) review of a multicenter trial: Local costs without local contextANNALS OF NEUROLOGY, Issue 2 2010Bernard Ravina MD, MSCE Multicenter clinical research involves parallel Institutional Review Board (IRB) reviews based on the premise that local review reflects aspects of the research environment. We examined the costs and effects of local IRB review of the consent and protocol in a multicenter clinical trial in Parkinson disease. Seventy-six percent of changes to the consent reflected standard institutional language, with no substantive changes to the protocol. The costs of this process exceeded $100,000. These findings support initiatives by the Office of Human Research Protections (OHRP) and the National Cancer Institute (NCI) to facilitate centralized reviews. This may be an opportune time for the National Institute of Neurological Disorders and Stroke (NINDS) to adopt a central review model. ANN NEUROL 2010;67:258,260 [source] Clinical optical coherence tomography of early articular cartilage degeneration in patients with degenerative meniscal tearsARTHRITIS & RHEUMATISM, Issue 5 2010Constance R. Chu Objective Quantitative and nondestructive methods for clinical diagnosis and staging of articular cartilage degeneration are important to the evaluation of potential disease-modifying treatments in osteoarthritis (OA). Optical coherence tomography (OCT) is a novel imaging technology that can generate microscopic-resolution cross-sectional images of articular cartilage in near real-time. This study tested the hypotheses that OCT can be used clinically to identify early cartilage degeneration and that OCT findings correlate with magnetic resonance imaging (MRI) T2 values and arthroscopy results. Methods Patients undergoing arthroscopy for degenerative meniscal tears were recruited under Institutional Review Board,approved protocols. Thirty consecutive subjects completing preoperative 3.0T MRI, arthroscopy, and intraoperative OCT comprised the study group. Qualitative and quantitative OCT results and MRI T2 values were compared with modified Outerbridge cartilage degeneration scores (0,4 scale) assigned at arthroscopy. Results Arthroscopic grades showed cartilage abnormality in 23 of the 30 patients. OCT grades were abnormal in 28 of the 30 patients. Both qualitative and quantitative OCT strongly correlated with the arthroscopy results (P = 0.004 and P = 0.0002, respectively, by Kruskal-Wallis test). Neither the superficial nor the deep cartilage T2 values correlated with the arthroscopy results. The quantitative OCT results correlated with the T2 values in the superficial cartilage (Pearson's r = 0.39, P = 0.03). Conclusion These data show that OCT can be used clinically to provide qualitative and quantitative assessments of early articular cartilage degeneration that strongly correlate with arthroscopy results. The correlation between the quantitative OCT values and T2 values for the superficial cartilage further supports the utility of OCT as a clinical research tool, providing quantifiable microscopic resolution data on the articular cartilage structure. New technologies for nondestructive quantitative assessment of human articular cartilage degeneration may facilitate the development of strategies to delay or prevent the onset of OA. [source] Technology preview: X-ray fused with magnetic resonance during invasive cardiovascular proceduresCATHETERIZATION AND CARDIOVASCULAR INTERVENTIONS, Issue 6 2007Luis F. Gutiérrez PhD Abstract Background: We have developed and validated a system for real-time X-ray fused with magnetic resonance imaging, MRI (XFM), to guide catheter procedures with high spatial precision. Our implementation overlays roadmaps,MRI-derived soft-tissue features of interest,onto conventional X-ray fluoroscopy. We report our initial clinical experience applying XFM, using external fiducial markers, electrocardiogram (ECG)- gating, and automated real-time correction for gantry and table movement. Methods: This prospective case series for technical development was approved by the NHLBI Institutional Review Board and included 19 subjects. Multimodality external fiducial markers were affixed to patients' skin before MRI, which included contrast-enhanced, 3D T1-weighted, or breath-held and ECG-gated 2D steady state free precession imaging at 1.5T. MRI-derived roadmaps were manually segmented while patients were transferred to a calibrated X-ray fluoroscopy system. Image spaces were registered using the fiducial markers and thereafter permitted unrestricted gantry rotation, table panning, and magnification changes. Static and ECG-gated MRI data were transformed from 3D to 2D to correspond with gantry and table position and combined with live X-ray images. Results: Clinical procedures included graft coronary arteriography, right ventricular free-wall biopsy, and iliac and femoral artery recanalization and stenting. MRI roadmaps improved operator confidence, and in the biopsy cases, outperformed the best available alternative imaging modality. Registration errors were increased when external fiducial markers were affixed to more mobile skin positions, such as over the abdomen. Conclusion: XFM using external fiducial markers is feasible during X-ray guided catheter treatments. Multimodality image fusion may prove a useful adjunct to invasive cardiovascular procedures. © 2007 Wiley-Liss, Inc. [source] Institutional Review Boards and Multisite Studies in Health Services Research: Is There a Better Way?HEALTH SERVICES RESEARCH, Issue 1 2005Jennifer L. Gold Objective. The following paper examines the issue of whether the current system for ethics review of multisite health services research protocols is adequate, or whether there exist alternative methods that should be considered. Principal Findings. (1) Investigators at different sites in a multisite project often have very different experiences with respect to the requirements and requests of the review board. Other problems include the waste of time and resources spent on document preparation for review boards, and delays in the commencement of research activities. (2) There are several possible reasons why there is variability in ethics review. These include the absence of standardized forms, differences in the background and experiences of board members, the influence of institutional or professional culture, and regional thinking. (3) Given the limited benefits derived from the variability in recommendations of multiple boards and the numerous problems encountered in seeking ethics approval from multiple boards suggest that some sort of reform is in order. Conclusions. The increasing number of multisite, health services research studies calls for a centralized system of ethics review. The local review model is simply not conducive to multisite studies, and jeopardizes the integrity of the research process. Centralized multisite review boards, together with standardized documents and procedure, electronic access to documentation, and training for board members are all possible solutions. Changes to the current system are necessary not only to facilitate the conduct of multisite research, but also to preserve the integrity of the ethics approval process in general. [source] When Scientists Deceive: Applying the Federal RegulationsTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 2 2009Collin C. O'Neil Deception is a useful methodological device for studying attitudes and behavior, but deceptive studies fail to fulfill the informed consent requirements in the U.S. federal regulations. This means that before they can be approved by Institutional Review Boards, they must satisfy the four regulatory conditions for a waiver or alteration of these requirements. To illustrate our interpretation, we apply the conditions to a recent study that used deception to show that subjects judged the same wine as more enjoyable when they believed it had a higher price. [source] Disclosing Conflicts of Interest in Clinical Research: Views of Institutional Review Boards, Conflict of Interest Committees, and InvestigatorsTHE JOURNAL OF LAW, MEDICINE & ETHICS, Issue 3 2006Kevin P. Weinfurt Ph.D. Strategies for disclosing investigators' financial interests to potential research participants have been adopted by many research institutions. However, little is known about how decisions are made regarding disclosures of financial interests to potential research participants, including what is disclosed and the rationale for making these determinations. We sought to understand the attitudes, beliefs, and practices of institutional review board chairs, conflict of interest committee chairs, and investigators regarding disclosure of financial interests to potential research participants. Several themes emerged, including general attitudes toward conflicts of interest, circumstances in which financial interests should be disclosed, rationales and benefits of disclosure, what should be disclosed, negative effects of and barriers to disclosure, and timing and presentation of disclosure. Respondents cited several rationales for disclosure, including enabling informed decision making, promoting trust in researchers and research institutions, and reducing legal liability. There was general agreement that disclosure should happen early in the consent process. Respondents disagreed about whether to disclose the amounts of particular financial interests. Clarifying the goals of disclosure and understanding how potential research participants use the information will be critical in efforts to ensure the integrity of clinical research and to protect the rights and interests of participants. [source] VULNERABILITY IN RESEARCH AND HEALTH CARE; DESCRIBING THE ELEPHANT IN THE ROOM?BIOETHICS, Issue 4 2008SAMIA A. HURST ABSTRACT Despite broad agreement that the vulnerable have a claim to special protection, defining vulnerable persons or populations has proved more difficult than we would like. This is a theoretical as well as a practical problem, as it hinders both convincing justifications for this claim and the practical application of required protections. In this paper, I review consent-based, harm-based, and comprehensive definitions of vulnerability in healthcare and research with human subjects. Although current definitions are subject to critique, their underlying assumptions may be complementary. I propose that we should define vulnerability in research and healthcare as an identifiably increased likelihood of incurring additional or greater wrong. In order to identify the vulnerable, as well as the type of protection that they need, this definition requires that we start from the sorts of wrongs likely to occur and from identifiable increments in the likelihood, or to the likely degree, that these wrongs will occur. It is limited but appropriately so, as it only applies to special protection, not to any protection to which we have a valid claim. Using this definition would clarify that the normative force of claims for special protection does not rest with vulnerability itself, but with pre-existing claims when these are more likely to be denied. Such a clarification could help those who carry responsibility for the protection of vulnerable populations, such as Institutional Review Boards, to define the sort of protection required in a more targeted and effective manner. [source] Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research ProtocolACADEMIC EMERGENCY MEDICINE, Issue 4 2007Jonathan Mansbach MD Abstract Background: Multicenter studies are becoming more common, and variability in local institutional review board (IRB) assessments can be problematic. Objective: To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. Methods: The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network http://www.emnet-usa.org Results: Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional review boards returned initial applications in a median of 19 days (IQR, 11,34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27,61 d). Seven sites did not participate in patient recruitment: two had institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. Conclusions: There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the review process and facilitate multicenter clinical research. [source] Use of High-Frequency, High-Resolution Ultrasound Before Mohs SurgeryDERMATOLOGIC SURGERY, Issue 6 2010ELLEN S. MARMUR MD BACKGROUND Although ultrasound imaging is employed ubiquitously today, its use to examine and assess the skin is a relatively new technology. We explored the clinical application and use of high-frequency, high-resolution ultrasound in Mohs micrographic surgery. OBJECTIVE To evaluate the ability of ultrasound to accurately determine lesion length and width of tumor borders in order to reduce the number of surgical stages. METHODS AND MATERIALS This was an institutional review board,approved single-center study of 26 Mohs surgery patients. Ultrasound images were taken to record lesion dimensions, and then the investigator documented clinical estimation of the first stage. Extirpation of the tumor and histological analysis were performed thereafter. RESULTS The results of 20 patients were included in the analysis. A paired-samples t -test revealed no significant difference between clinical and ultrasound widths (t=,1.324, p=.20). Similarly, there was no significant difference between the lengths found from clinical assessment and ultrasound (t=,1.093, p=.29). For different tumor types, there was no significant difference between clinical and ultrasound widths or lengths for basal cell carcinoma (t=,1.307, p=.23; t=,1.389, p=.20) or squamous cell cancer (t=,0.342, p=.73; t=0.427, p=.68). CONCLUSION There is a diagnostic role for high-resolution ultrasound in Mohs surgery regarding the delineation of surgical margins, but its limitations preclude its practical adoption at this time. The ultrasound equipment was loaned to the investigators. Funding for the study was provided by Longport, Inc. [source] Combined Excimer Laser and Topical Tacrolimus for the Treatment of Vitiligo: A Pilot StudyDERMATOLOGIC SURGERY, Issue 2 2004Adam Z. Kawalek BA Background. Vitiligo is an acquired skin disorder that is characterized by well-defined, often symmetric white patches. Although current therapeutic modalities are directed toward increasing melanocyte melanin production, few treatment modalities address the immunologic nature of the disease. Objective. To determine whether excimer laser, a known therapeutic modality, in combination with tacrolimus, a topical immunomodulator, accelerate response time and/or improve the degree of response in patients with this disorder. Methods. Eight subjects diagnosed with vitiligo were recruited to participate in this institutional review board,approved double-blind, placebo-controlled study. Twenty-four symmetric vitiliginous patches (elbows, knees) from eight subjects received excimer laser treatment three times per week for 24 treatments or 10 weeks. Additionally, topical tacrolimus 0.1% ointment (Protopic) and placebo (Aquaphor) were applied to randomized patches (left or right) twice daily throughout the length of the trial. Vitiliginous patches were monitored with photographs at baseline, every 2 weeks, and 6 months after treatment. Biopsies were performed on subjects with significant results. Results. Twenty vitiliginous patches from six subjects qualified for evaluation. Fifty percent of patches treated with combination excimer laser and tacrolimus achieved a successful response (75% repigmentation) compared with 20% for the placebo group. Subjects who responded successfully repigmented faster (19%) with combination therapy compared with excimer laser alone. Additionally, three subjects experienced transient hyperpigmentation in lesions treated with combination therapy. Conclusion. Combining topical immunomodulators with known phototherapeutic modalities may represent a key advancement in the treatment of disease. [source] Evaluation of the hepatic artery anastomosis by intraoperative sonography with high-frequency transducer in right-lobe graft living donor liver transplantationJOURNAL OF CLINICAL ULTRASOUND, Issue 1 2010Han Song Mun MD Abstract Objective To describe the usefulness of intraoperative ultrasonography (IOUS) with high-frequency transducer in living donor liver transplantation (LDLT) using right-lobe graft (RLG). Method This retrospective study was approved by our institutional review board. We performed IOUS in 22 patients (17 men and 5 women, aged 51 ± 9.0 years) during LDLT with RLG using a Sequoia 512 scanner with an 8,12-MHz linear transducer. Hepatic artery (HA) anastomosis was identified on gray-scale US, and the diameter and percentage of stenosis of the anastomosis were measured. The HA was evaluated to detect thrombus or dissection in the region of anastomosis. Doppler study of the graft HA was also performed. Patients were divided into those with and without abnormalities, including thrombosis, dissection, and abnormal Doppler parameters (peak systolic velocity < 30 cm/s or > 2 m/s, resistance index < 0.5, and systolic acceleration time > 80 msec). Result On gray-scale and Doppler IOUS study, abnormalities were found in 10 of 22 patients. Diagnoses were anastomotic stenosis (n = 2), celiac stenosis (n = 1), compromise of HA inflow due to systemic hypotension (n = 1), HA thrombosis (n = 2), and HA dissection (n = 4). Re-anastomoses were done in 3 case (2 stenoses and 1 thrombosis). Uneventful postoperative recovery occurred in the other 7 patients without re-anastomosis. Conclusion IOUS with high-frequency transducer is a useful method to make an early diagnosis of HA complications of LDLT with RLG. © 2009 Wiley Periodicals, Inc. J Clin Ultrasound, 2010 [source] The perils of working at home: IRB "mission creep" as context and content for an ethnography of disciplinary knowledgesAMERICAN ETHNOLOGIST, Issue 4 2006RENA LEDERMAN Among kinds of fieldwork "at home," ethnographies of higher education inevitably draw on informal gleanings of everyday insider experience. Such informality is implicitly outlawed by federal human-subjects research regulations, which presume a clinical biomedical model that formally demarcates research from other activities. Intricately implicated in these circumstances, this article describes a comparative investigation into the methodologically embedded ethical conventions of anthropology and related disciplines for which institutional review board (IRB) participation itself became inadvertently informative, work that also reveals a conflict between the ethics of human-subjects protections (confidentiality) and of collegial exchange (citation). [source] Informed Consent: Documenting the Intersection of Bureaucratic Regulation and Ethnographic PracticePOLAR: POLITICAL AND LEGAL ANTHROPOLOGY REVIEW, Issue 2 2007Jennifer Shannon Standardized institutional review board (IRB) procedures suggest that informed consent can be enacted in the same way everywhere,across disciplines and across different cultural communities. With attention to documents as artifacts and embedding ethics, I consider consent documents to be located at a productive site for anthropological analysis the intersection of bureaucratic and ethnographic practice. Through fieldwork that engaged both American Indians in Chicago and museum professionals in Washington, D.C., I was able to view these procedures in a variety of contexts. Unlike the joking references to IRB scripts when interviewing museum professionals, American Indians were wary of such procedures. The particular meaning attached to signing documents varied in these communities and in one case prompted people to challenge and change the consent protocol that I would use in my fieldwork practice. This comparative approach shows how different institutions are represented by and transact through documents in ways that significantly impact the nature of fieldwork relations. [source] Auditory Brainstem Response versus Magnetic Resonance Imaging for the Evaluation of Asymmetric Sensorineural Hearing Loss,THE LARYNGOSCOPE, Issue 10 2004Roberto A. Cueva MD Abstract Objectives/Hypothesis: Auditory brainstem response (ABR) testing and magnetic resonance imaging (MRI) are compared for the evaluation of patients with asymmetric sensorineural hearing loss (SNHL). MRI with gadolinium administration is the current gold standard for identifying retrocochlear lesions causing asymmetric SNHL. The study seeks to determine the sensitivity and specificity of ABR in screening for possible retrocochlear pathology. Most important among SNHL etiologies are neoplastic lesions such as vestibular schwannomas, cerebellopontine angle (CPA) tumors, as well as multiple sclerosis, stroke, or other rare nonneoplastic causes. The study results will allow the author to recommend a screening algorithm for patients with asymmetric SNHL. Study Design: The study is a multi-institutional, institutional review board approved, prospective, nonrandomized comparison of ABR and MRI for the evaluation of patients with asymmetric SNHL. Methods: Three hundred twelve patients (between the ages of 18 and 87) with asymmetric SNHL completed the study. Asymmetric SNHL was defined as 15 dB or greater asymmetry in two or more frequencies or 15% or more asymmetry in speech discrimination scores (SDS). These patients prospectively underwent both ABR and MRI. The ABR and MRI were interpreted independently in a blinded fashion. In addition to the ABR and MRI results, a variety of clinical and demographic data were collected. Results: Thirty-one (9.94%) patients of the study population of 312 were found on MRI to have lesions causing their SNHL. Of the 31 patients with causative lesions on MRI there were 24 vestibular schwannomas, 2 glomus jugulare tumors, 2 ectatic basilar arteries with brainstem compression, 1 petrous apex cholesterol granuloma, 1 case of possible demyelinating disease, and 1 parietal lobe mass. Twenty-two of the 31 patients had abnormal ABRs, whereas 9 patients (7 with small vestibular schwannomas) had normal ABRs. This gives an overall false-negative rate for ABR of 29%. The false-positive rate was found to be 76.84%. Sensitivity of ABR as a screening test was 71%, and specificity was 74%. Conclusions: Ten percent of patients with asymmetric SNHL (by this study's criteria) are likely to have causative lesions found on MRI. Although the recently reported annual incidence of vestibular schwannoma in the general population is 0.00124%, for patients with asymmetric SNHL in this study, the incidence was 7.7% (nearly 4 orders of magnitude higher). ABR has been demonstrated to have low sensitivity and specificity in the evaluation of these patients and cannot be relied on as a screening test for patients with asymmetric SNHL. Keeping the use of MRI conditional on the results of ABR will annually result in missed or delayed diagnosis of causative lesions in 29 patients per 1,000 screened. The author recommends abandoning ABR as a screening test for asymmetric SNHL and adoption of a focused MRI protocol as the screening test of choice (within certain guidelines). [source] Using Screen-Based Simulation to Improve Performance During Pediatric ResuscitationACADEMIC EMERGENCY MEDICINE, Issue 2009Kevin J. Biese MD Abstract Objectives:, To assess the ability of a screen-based simulation-training program to improve emergency medicine and pediatric resident performance in critical pediatric resuscitation knowledge, confidence, and skills. Methods:, A pre,post, interventional design was used. Three measures of performance were created and assessed before and after intervention: a written pre-course knowledge examination, a self,efficacy confidence score, and a skills-based high-fidelity simulation code scenario. For the high-fidelity skills assessment, independent physician raters recorded and reviewed subject performance. The intervention consisted of eight screen-based pediatric resuscitation scenarios that subjects had 4 weeks to complete. Upon completion of the scenarios, all three measures were repeated. For the confidence assessment, summary pre- and post-test summary confidence scores were compared using a t-test, and for the skills assessment, pre-scores were compared with post-test measures for each individual using McNemar's chi-square test for paired samples. Results:, Twenty-six of 35 (71.3%) enrolled subjects completed the institutional review board,approved study. Increases were observed in written test scores, confidence, and some critical interventions in high-fidelity simulation. The mean improvement in cumulative confidence scores for all residents was 10.1 (SD ±4.9; range 0,19; p < 0.001), with no resident feeling less confident after the intervention. Although overall performance in simulated codes did not change significantly, with average scores of 6.65 (±1.76) to 7.04 (±1.37) out of 9 possible points (p = 0.58), improvement was seen in the administering of appropriate amounts of IV fluids (59,89%, p = 0.03). Conclusions:, In this study, improvements in resident knowledge, confidence, and performance of certain skills in simulated pediatric cardiac arrest scenarios suggest that screen-based simulations may be an effective way to enhance resuscitation skills of pediatric providers. These results should be confirmed using a randomized design with an appropriate control group. [source] Randomized Double-blind Placebo Controlled Crossover Study of Acetaminophen, Ibuprofen, Acetaminophen/Hydrocodone, and Placebo for the Relief of Pain From a Standard Painful StimulusACADEMIC EMERGENCY MEDICINE, Issue 9 2009James R. Miner MD Abstract Objectives:, The objective was to compare subjects' change in perceived acute pain from an identical painful stimulus after receiving three separate, commonly used pain medications and placebo. Methods:, This was an institutional review board,approved, randomized, double-blind crossover study of healthy human volunteers. Subjects received 1000 mg of acetaminophen, 800 mg of ibuprofen, the combination of 650 mg of acetaminophen with 10 mg of hydrocodone, or placebo (800 mg of lactose) in a randomized order over four separate occasions each 1 week apart. Prior to receiving the drug on each study day, subjects placed their nondominant hand in a bath of 0°C water for 45 seconds. The bath was divided into two sections; the larger was the reservoir of cooled water monitored at 0°C, and the other half was filled from constant overflow. Water drained from the overflow section into the cooling unit and was then pumped up into the base of the reservoir through a diffusion grid. Subjects completed a 100-mm visual analog scale (VAS) representing perceived pain during the exposure. The cold water exposure and VAS were repeated 1 hour after receiving the study drug, and then subjects were observed for side effects for 4 hours. Data were compared using descriptive statistics, 95% confidence intervals (CIs), and repeated-measures analysis of variance (ANOVA). Results:, Twenty-five subjects were enrolled. The mean VAS preexposure was 56.9 mm (±15.1 mm; range = 5 to 92 mm). The mean decrease in VAS after receiving the study drug for acetaminophen was 10.2% (95% CI = ,1.4 to 20.4), for ibuprofen was ,6.6% (95% CI = ,16.5 to 3.20), for acetaminophen/hydrocodone was 9.5% (95% CI = 1.4 to 20.4), and for placebo was ,6.9% (95% CI = ,15.2 to 1.4). The range in change in pain scores for all agents was ,91.3% to 57.6%. Mild side effects (nausea, dizziness, or somnolence) were reported in 11 subjects (44%) after receiving acetaminophen/hydrocodone; no other side effects were reported. Conclusions:, There was a wide range of changes in pain scores from this identical painful stimulus after receiving the study medications. Acetaminophen and acetaminophen/hydrocodone resulted in a similar decrease in pain (10.2 and 9.5%), while ibuprofen and placebo had a similar lack of effect (,6.6 and ,6.9%). Forty-four percent of subjects receiving acetaminophen/hydrocodone reported mild side effects; no other side effects were seen. In this noninflammatory pain model, the VAS is not able to distinguish differences in pain relief between acetaminophen and acetaminophen/hydrocodone or ibuprofen and placebo. [source] Local institutional review board (IRB) review of a multicenter trial: Local costs without local contextANNALS OF NEUROLOGY, Issue 2 2010Bernard Ravina MD, MSCE Multicenter clinical research involves parallel Institutional Review Board (IRB) reviews based on the premise that local review reflects aspects of the research environment. We examined the costs and effects of local IRB review of the consent and protocol in a multicenter clinical trial in Parkinson disease. Seventy-six percent of changes to the consent reflected standard institutional language, with no substantive changes to the protocol. The costs of this process exceeded $100,000. These findings support initiatives by the Office of Human Research Protections (OHRP) and the National Cancer Institute (NCI) to facilitate centralized reviews. This may be an opportune time for the National Institute of Neurological Disorders and Stroke (NINDS) to adopt a central review model. ANN NEUROL 2010;67:258,260 [source] Short-term Functional Decline and Service Use in Older Emergency Department Patients With Blunt InjuriesACADEMIC EMERGENCY MEDICINE, Issue 7 2010Scott T. Wilber MD ACADEMIC EMERGENCY MEDICINE 2010; 17:679,686 © 2010 by the Society for Academic Emergency Medicine Abstract Background:, Injuries are a common reason for emergency department (ED) visits by older patients. Although injuries in older patients can be serious, 75% of these patients are discharged home after their ED visit. These patients may be at risk for short-term functional decline related to their injuries or treatment. Objectives:, The objectives were to determine the incidence of functional decline in older ED patients with blunt injuries not requiring hospital admission for treatment, to describe their care needs, and to determine the predictors of short-term functional decline in these patients. Methods:, This institutional review board,approved, prospective, longitudinal study was conducted in two community teaching hospital EDs with a combined census of 97,000 adult visits. Eligible patients were , 65 years old, with blunt injuries <48 hours old, who could answer questions or had a proxy. We excluded those too ill to participate; skilled nursing home patients; those admitted for surgery, major trauma, or acute medical conditions; patients with poor baseline function; and previously enrolled patients. Interviewers collected baseline data and the used the Older Americans Resources and Services (OARS) questionnaire to assess function and service use. Potential predictors of functional decline were derived from prior studies of functional decline after an ED visit and clinical experience. Follow-up occurred at 1 and 4 weeks, when the OARS questions were repeated. A three-point drop in activities of the daily living (ADL) score defined functional decline. Data are presented as means and proportions with 95% confidence intervals (CIs). Logistic regression was used to model potential predictors with functional decline at 1 week as the dependent variable. Results:, A total of 1,186 patients were evaluated for eligibility, 814 were excluded, 129 refused, and 13 were missed, leaving 230 enrolled patients. The mean (±SD) age was 77 (±7.5) years, and 70% were female. In the first week, 92 of 230 patients (40%, 95% CI = 34% to 47%) had functional decline, 114 of 230 (49%, 95% CI = 43% to 56%) had new services initiated, and 76 of 230 had an unscheduled medical contact (33%, 95% CI = 27% to 39%). At 4 weeks, 77 of 219 had functional decline (35%, 95% CI = 29% to 42%), 141 of 219 had new services (65%, 95% CI = 58% to 71%), and 123 of 219 had an unscheduled medical contact (56%, 95% CI = 49% to 63%), including 15% with a repeated ED visit and 11% with a hospital admission. Family members provided the majority of new services at both time periods. Significant predictors of functional decline at 1 week were female sex (odds ratio [OR] = 2.2, 95% CI = 1.1 to 4.5), instrumental ADL dependence (IADL; OR = 2.5, 95% CI = 1.3 to 4.8), upper extremity fracture or dislocation (OR = 5.5, 95% CI = 2.5 to 11.8), lower extremity fracture or dislocation (OR = 4.6, 95% CI = 1.4 to 15.4), trunk injury (OR = 2.4, 95% CI = 1.1 to 5.3), and head injury (OR = 0.48, 95% CI = 0.23 to 1.0). Conclusions:, Older patients have a significant risk of short-term functional decline and other adverse outcomes after ED visits for injuries not requiring hospitalization for treatment. The most significant predictors of functional decline are upper and lower extremity fractures. [source] U.S. Federal Regulations for Emergency Research: A Practical Guide and CommentaryACADEMIC EMERGENCY MEDICINE, Issue 1 2008Andrew McRae MD Abstract Emergency medicine research requires the enrollment of subjects with varying decision-making capacities, including capable adults, adults incapacitated by illness or injury, and children. These different categories of subjects are protected by multiple federal regulations. These include the federal Common Rule, the Department of Health and Human Services (DHHS) regulations for pediatric research, and the Food and Drug Administration's (FDA) Final Rule for the Exception from the Requirements of Informed Consent in Emergency Situations. Investigators should be familiar with the relevant federal research regulations to optimally protect vulnerable research subjects, and to facilitate the institutional review board (IRB) review process. IRB members face particular challenges in reviewing emergency research. No regulations exist for research enrolling incapacitated subjects using proxy consent. The wording of the Final Rule may not optimally protect vulnerable subjects. It is also difficult to apply conflicting regulations to a single study that enrolls subjects with differing decision-making capacities. This article is intended as a guide for emergency researchers and IRB members who review emergency research. It reviews the elements of Federal Regulations that apply to consent, subject selection, privacy protection, and the analysis of risks and benefits in all emergency research. It explores the challenges for IRB review listed above, and offers potential solutions to these problems. [source] Variation in Institutional Review Board Responses to a Standard, Observational, Pediatric Research ProtocolACADEMIC EMERGENCY MEDICINE, Issue 4 2007Jonathan Mansbach MD Abstract Background: Multicenter studies are becoming more common, and variability in local institutional review board (IRB) assessments can be problematic. Objective: To investigate the variability of IRB responses to a multicenter observational study of children presenting to emergency departments. Methods: The authors collected the original IRB applications, subsequent correspondence, and a survey assessing submission timing and response and the nature of IRB queries. The study was conducted as part of the Emergency Medicine Network http://www.emnet-usa.org Results: Of 37 sites initiating the IRB process, 34 (92%) participated in this IRB-approved study. Institutional review boards returned initial applications in a median of 19 days (IQR, 11,34 d), and 91% considered the protocol to be minimal risk. Of 34 submissions, 13 required no changes, 18 received conditional approvals, and 3 were deferred. The median time from initial submission to final approval was 42 days (IQR, 27,61 d). Seven sites did not participate in patient recruitment: two had institutional issues, one obtained IRB approval too late for participation, and four sites (12%) reported that IRB hurdles contributed to their lack of participation. Nonetheless, 68% of sites that recruited patients reported that the overall experience made them more likely to participate in future multicenter research. Conclusions: There was substantial variation in IRB assessment of a standard protocol in this study. The burden of the application process contributed to some investigators not participating, but the majority of investigators remain enthusiastic about multicenter research. A national IRB may streamline the review process and facilitate multicenter clinical research. [source] TOWARD CASE-BASED REASONING FOR DIABETES MANAGEMENT: A PRELIMINARY CLINICAL STUDY AND DECISION SUPPORT SYSTEM PROTOTYPECOMPUTATIONAL INTELLIGENCE, Issue 3 2009Cindy Marling This paper presents a case-based decision support system prototype to assist patients with Type 1 diabetes on insulin pump therapy. These patients must vigilantly maintain blood glucose levels within prescribed target ranges to prevent serious disease complications, including blindness, neuropathy, and heart failure. Case-based reasoning (CBR) was selected for this domain because (a) existing guidelines for managing diabetes are general and must be tailored to individual patient needs; (b) physical and lifestyle factors combine to influence blood glucose levels; and (c) CBR has been successfully applied to the management of other long-term medical conditions. An institutional review board (IRB) approved preliminary clinical study, involving 20 patients, was conducted to assess the feasibility of providing case-based decision support for these patients. Fifty cases were compiled in a case library, situation assessment routines were encoded to detect common problems in blood glucose control, and retrieval metrics were developed to find the most relevant past cases for solving current problems. Preliminary results encourage continued research and work toward development of a practical tool for patients. [source] HARMONIZING REGULATIONS FOR BIOMEDICAL RESEARCH: A CRITICAL ANALYSIS OF THE US AND VENEZUELAN SYSTEMSDEVELOPING WORLD BIOETHICS, Issue 3 2008DANNIE DI TILLIO-GONZALEZ ABSTRACT This article aims to compare the national legal systems that regulate biomedical research in an industrialized country (United States) and a developing country (Venezuela). A new international order is emerging in which Europe, Japan and the United States (US) are revising common guidelines and harmonizing standards. In this article, we analyze , as an example , the US system. This system is controlled by a federal agency structured to regulate research funded by the federal government uniformly, either in the US or abroad. In contrast, in Venezuela, a developing country, the creation of a centralized system is a slow process. Different types of ethical committees review research projects using non-uniform criteria. Consequently, various parallel organizations that conduct biomedical research, such as universities, research institutes and private hospitals have diverse regulations operating at a local level. Thus, the most relevant difference between the Venezuelan and the US systems is the degree of standardization. In the US, the review process is performed by institutional review boards (IRBs), which have a similar organization and maintain relationships with a centralized agency, following standard regulations. Although new proposals for establishing national regulations are currently being considered in Venezuela, the success of these initiatives will depend on promoting governmental efforts to create a more structured centralized system supported by a national regulatory framework. This system will need governmental financial support at all levels. This article proposes an integrated system to regulate research with human participants in Venezuela and other developing countries. [source] Variation in Institutional Review Board Responses to a Standard Protocol for a Multicenter Clinical TrialACADEMIC EMERGENCY MEDICINE, Issue 6 2001Thomas O. Stair MD Abstract. Multicenter clinical trials require approval by multiple local institutional review boards (IRBs). The Multicenter Airway Research Collaboration mailed a clinical trial protocol to its U.S. investigators and 44 IRBs ultimately reviewed it. Objective: To describe IRB responses to one standard protocol and thereby gain insight into the advantages and disadvantages of local IRB review. Methods: Two surveys were mailed to participants, with telephone follow-up of nonrespondents. Survey 1 was mailed to 82 investigators across North America. Survey 2 was mailed to investigators from 44 medical centers in 17 U.S. states. Survey 1 asked about each investigator's local IRB (e.g., frequency of meetings, membership), whereas survey 2 asked about IRB queries and concerns related to the submitted clinical trial. Results: Both surveys had 100% response rate. Investigators submitted applications a median of 58 days (interquartile range [IQR], 40-83) after receipt of the protocol, and IRB approval took an additional 38 days (IQR, 26-62). Although eight applications were approved with little or no changes, IRBs requested an average of 3.5 changes per site. Changes involved study logistics and supervision for 45%, the research process for 43%, and the consent form for 91%. Despite these numerous requests, all eventually approved the basic protocol, including inclusion criteria, intervention, and data collection. Conclusions: The IRBs showed extreme variability in their initial responses to a standard protocol, but ultimately all gave approval. Almost all IRBs changed the consent form. A national, multicenter IRB process might streamline ethical review and warrants further consideration. [source] | ||||||||||||||||