Background: The Veterans Administration is an ideal setting for multisite studies; however, individual VA Institutional Review Board (IRB) approval is necessary. This study examines the burden of multisite IRB approval on a Health Services Research and Development (HSRD) ventral hernia outcomes observational study.

Methods: Data gathered on the IRB process per site included time required for application completion, staff training and compliance, IRB affiliation (VA or university), approval status, and time to IRB approval. Wilcoxon rank sum tests were used to determine differences in median times for application completion and approval. Financial and temporal expenses were calculated.

Results: Significant differences were found in median time to complete applications by IRB affiliation (P < .01) and median time to approval by changes required to the consent letter (P < .05).

Conclusions: The IRB process for a multisite observational study is expensive in both time and money. A VA national IRB for multisite studies would significantly decrease the financial and temporal burden for observational studies.

Download full-text PDF

Source
http://dx.doi.org/10.1016/j.amjsurg.2005.07.024DOI Listing

Publication Analysis

Top Keywords

irb approval
12
institutional review
8
multisite observational
8
observational study
8
multisite studies
8
irb
8
irb process
8
application completion
8
irb affiliation
8
differences median
8

Similar Publications

Purpose: Vertebral body tethering (VBT) is a non-fusion surgical option for adolescent idiopathic scoliosis (AIS) that requires a postoperative (PO) chest tube. This study evaluates whether 48 h of PO TXA reduces chest tube (CT) drainage and retention compared to 24 h of TXA following VBT for AIS.

Methods: Consecutively treated patients with a diagnosis of AIS who underwent VBT were assessed.

View Article and Find Full Text PDF

Background: Artificial Intelligence (AI) is increasingly applied in healthcare to boost productivity, reduce administrative workloads, and improve patient outcomes. In nursing, AI offers both opportunities and challenges. This study explores nurses' perspectives on implementing AI in nursing practice within the context of Jordan, focusing on the perceived benefits and concerns related to its integration.

View Article and Find Full Text PDF

Menopause and obstructive sleep apnea: revealing an independent mediating role of visceral fat beyond body mass index.

BMC Endocr Disord

January 2025

Department of Respiratory and Critical Care Medicine, Renmin Hospital of Wuhan University, Wuhan, 430060, China.

Background: Menopause is a significant phase in women's health, in which the incidence of obstructive sleep apnea (OSA) is significantly increased. Body fat distribution changes with age and hormone levels in postmenopausal women, but the extent to which changes in body fat distribution affect the occurrence of OSA is unclear.

Methods: This research performed a cross-sectional analysis utilizing data from the 2015-2016 National Health and Nutrition Examination Survey (NHANES).

View Article and Find Full Text PDF

Background: Bullying, encompassing physical, psychological, social, or educational harm, affects approximately 1 in 20 United States teens aged 12-18. The prevalence and impact of bullying, including online bullying, necessitate a deeper understanding of risk and protective factors to enhance prevention efforts. This study investigated the key risk and protective factors most highly associated with adolescent bullying victimization.

View Article and Find Full Text PDF

Nowadays, chemotherapy and immunotherapy remain the major treatment strategies for Triple-Negative Breast Cancer (TNBC). Identifying biomarkers to pre-select and subclassify TNBC patients with distinct chemotherapy responses is essential. In the current study, we performed an unbiased Reverse Phase Protein Array (RPPA) on TNBC cells treated with chemotherapy compounds and found a leading significant increase of phosphor-AURKA/B/C, AURKA, AURKB, and PLK1, which fall into the mitotic kinase group.

View Article and Find Full Text PDF

Want AI Summaries of new PubMed Abstracts delivered to your In-box?

Enter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!