Structure and practice of institutional review boards in the United States

OBJECTIVE: The institutional review board (IRB) is a critical element in the protection of patients' and subjects' rights with regard to their participation in research protocols. The purpose of this study was to describe the structure and current practices of IRBs in the United States. METHODS: A self-administered questionnaire was mailed to the IRB chair of each U.S. hospital with a capacity of at least 400 beds (n = 907). The survey contained 21 questions outlining committee size and structure, review of research proposals, and policies concerning scientific misconduct. Chairs also were asked what advice they would offer a young investigator preparing a proposal for submission. RESULTS: A total of 488 surveys (54%) were returned; 447 of the responding institutions had an IRB committee. Committees had an average of 14 members, representing 27 medical specialties. Orthopedics had the least IRB representation (10% of committees), followed by emergency medicine (12%) and ophthalmology (15%). The majority of research proposals go through 5 specific steps once submitted for review. Common reasons for proposal rejection were improperly designed consent form (54%), poor study design (44%), unacceptable risk to subjects (34%), ethical or legal reasons (24%), and scientific merit (14%). When a research proposal is rejected, 86% of the responding IRBs assist the investigator in making appropriate revisions. Although a number of IRBs (17%) have dealt with scientific misconduct allegations, only 58% have a written policy regarding research integrity. CONCLUSION: Despite variations in committee structure and representation, IRBs have similar procedures for governing research. Investigators should be familiar with these procedures and are encouraged to discuss their proposal with an IRB representative prior to formal review.     

Ribose-enhanced synthesis of UTP, CTP, and GTP from parent nucleosides in cardiac myocytes

1. Characterization of allelic variants of the TPMT gene (TPMT) responsible for changes in TPMT activity, and elucidation of the mechanism by which these alleles act, are required because of the clinical importance of this polymorphism for patients receiving thiopurine drugs. 2. We defined the mutational and allelic spectrum of TPMT in a group of 191 Europeans. Using PCR-SSCP, we screened for mutation the entire coding sequence, the exon-intron boundaries, the promoter region and the 3'-flanking region of the gene. Six mutations were detected throughout the ten exons and seven TPMT alleles were characterized. Four of them, TPMT*2, *3A, *3C and *7, harbouring the known mutations, G238C, G460A, A719G or T681G, were nonfunctional and accounted for 0.5, 5.7, 0.8 and 0.3% of the allele totality, respectively. 3. Within the promoter region, six alleles corresponding to a variable number of tandem repeats (VNTR), were identified. VNTR*V4 and *V5a which harbour four or five repeats of a 17-18 bp unit, were the most frequent (55% and 34%, respectively). The other VNTR alleles, having from five to eight repeats, were rarer. 4. The TPMT phenotype was correctly predicted by genotyping for 87% of individuals. A clear negative correlation between the total number of repeats from both alleles and the TPMT activity level was observed, indicating that VNTRs contribute to interindividual variations of TPMT activity. Therefore, additional analysis of the promoter region of TPMT can improve the phenotype prediction rate by genotyping.     

Pulmonary vein stenosis after catheter ablation of atrial fibrillation

BACKGROUND: This report describes the complication of pulmonary vein stenosis with resultant severe pulmonary hypertension that developed in 2 patients after successful catheter ablation of chronic atrial fibrillation. METHODS AND RESULTS: Three months after successful catheter ablation of atrial fibrillation, both patients developed progressive dyspnea and pulmonary hypertension. Both were found to have severe stenosis of all 4 pulmonary veins near the junction with the left atrium. Balloon dilation of the stenotic pulmonary veins was performed in these patients, with improvement in dyspnea and pulmonary hypertension. CONCLUSIONS: The complication of pulmonary vein stenosis is potentially life-threatening, and the application of radiofrequency current within the pulmonary veins with standard catheter technology should be avoided. This complication can be treated with balloon dilation, although the long-term course is unknown.     

A primate model for enteral nutrition by tube

To establish an animal model for the controlled study of enteral nutrition by tube, five adult chair-adapted primates (Macaca fasicularis) had gastrostomy and jejunostomy tubes placed for the delivery of a modified protein isolate diet. Following 7 days of postoperative depletion with a hypocaloric infusion of dextrose (20 kcal, 0 g N/kg/day), the animals were repleted for 10 days with tube feedings (124 kcal, 0.73 g N/kg/day). There was no operative mortality or morbidity and each animal demonstrated conversion to anabolism by significant weight gain, positive nitrogen balance, and net protein synthesis as determined by [15N]glycine protein turnover rates. Significant correlation was found between caloric intake and nitrogen balance at the level of nitrogen provided in this diet (r = 0.88, p less than 0.05). This model was found to be well suited for the surgical and nutritional techniques required for the long-term study of enteral nutrition by tube.     

Sensory integration of auditory and visual information.

In exp. I with 3 male and 1 female o, the bisensory recognition of simultaneously presented auditory and visual verbal information was measured as a function of auditory and visual recognition. It is shown that bisensory performance is superior to performance predicted by a model that assumes the 2 modalities are processing the information independently. Instead integrative processing is suggested. In previous studies using theory of signal detectability (tsd), independent processing of bisensory presentations of mathematically equivalent stimuli has been shown. Present results suggest that the mathematically equated stimuli in those studies were not cognitively equivalent. Exp. Ii with 3 male os lends support to this notion by (a) using verbal information in a tsd paradigm, and (b) showing that when the stimuli are equivalent the results are consistent with a model in which bisensory processing occurs integratively on a common decision axis. However, when the stimuli to each mode are not equivalent, results are consistent with a model in which bisensory processing occurs independently on separate decision axes. (french summary) (PsycINFO Database Record (c) 2010 APA, all rights reserved)     

Comparison of urinary excretion of UV-absorbing constituents in healthy subjects and patients with rheumatoid arthritis using analytical isotachophoresis

Analytical isotachophoresis has been applied to the separation of urinary constituents in healthy controls and patients with rheumatoid and osteoarthritis. Various methods of comparing isotachograms have been investigated. Significant differences have been demonstrated between the pattern of UV-absorbing components in patients with rheumatoid arthritis and healthy subjects.     

Patient-therapist matching for prediction of optimal and minimal therapeutic outcome

Exp I (a) established outcome criteria using evaluation ratings from 24 patient-therapist dyads; (b) produced 11 quantifiable personality predictors through factor analysis of 18 therapists' and 65 patients' scores on a test battery (including the MMPI and the Omnibus Personality Inventory); (c) identified 3 typological categories of both patients and therapists homogeneous with respect to these variables and 2 groups of therapists each homogeneous with respect to therapeutic approach; and (d) derived 5 regression equations predicting outcome for each patient and therapist group. Exp II, with 24 therapists and 56 patients who were university students or their spouses, utilized these findings to form 2 experimental dyad groups for which (a) optimal or (b) minimal therapist outcome ratings were predicted, and 2 control groups each for both optimal and deterioration matches that controlled for patient type and therapist type, respectively. Results indicate significant differences between mean outcome in the comparison of the deterioration-matched group both with its control and the optimally matched group. Findings demonstrate the usefulness of carefully planned matching techniques. (18 ref) (PsycINFO Database Record (c) 2010 APA, all rights reserved)